Difference between revisions of "Cutaneous T-cell lymphoma"
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[[#top|Back to Top]] | [[#top|Back to Top]] | ||
</div> | </div> | ||
− | {{#lst: | + | {{#lst:Editorial board transclusions|tcl}} |
''Are you looking for a regimen but can't find it here? For placebo or observational studies in this condition, please visit [[Cutaneous T-cell lymphoma - null regimens|this page]]. If you still can't find it, please let us know so we can add it!'' | ''Are you looking for a regimen but can't find it here? For placebo or observational studies in this condition, please visit [[Cutaneous T-cell lymphoma - null regimens|this page]]. If you still can't find it, please let us know so we can add it!'' | ||
+ | *''We have moved [[How I Treat]] articles to a dedicated page.'' | ||
{| class="wikitable" style="float:right; margin-right: 5px;" | {| class="wikitable" style="float:right; margin-right: 5px;" | ||
|- | |- | ||
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{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
=Guidelines= | =Guidelines= | ||
+ | '''Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.''' | ||
==ESMO== | ==ESMO== | ||
− | *'''2018:''' Willemze et al. [https://www. | + | *'''2018:''' Willemze et al. [https://doi.org/10.1093/annonc/mdy133 Primary cutaneous lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up] [https://www.ncbi.nlm.nih.gov/pubmed/29878045 PubMed] |
− | + | **'''2013:''' Willemze et al. [https://doi.org/10.1093/annonc/mdt242 Primary cutaneous lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up] [https://pubmed.ncbi.nlm.nih.gov/23868906/ PubMed] | |
− | *''' | + | **'''2010:''' Willemze & Dreyling. [https://doi.org/10.1093/annonc/mdq183 Primary cutaneous lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up] [https://pubmed.ncbi.nlm.nih.gov/20555075/ PubMed] |
− | + | **'''2009:''' Willemze & Dreyling. [https://doi.org/10.1093/annonc/mdp147 Primary cutaneous lymphoma: ESMO clinical recommendations for diagnosis, treatment and follow-up] [https://pubmed.ncbi.nlm.nih.gov/19454428/ PubMed] | |
− | *[https://www.nccn.org/ | + | **'''2008:''' Dummer & Dreyling. [https://doi.org/10.1093/annonc/mdn095 Primary cutaneous lymphoma: ESMO clinical recommendations for diagnosis, treatment and follow-up] [https://pubmed.ncbi.nlm.nih.gov/18456777/ PubMed] |
− | *[https://www.nccn.org/ | + | **'''2007:''' Dummer. [https://doi.org/10.1093/annonc/mdm040 Primary cutaneous lymphomas: ESMO clinical recommendations for diagnosis, treatment and follow-up] [https://pubmed.ncbi.nlm.nih.gov/17491051/ PubMed] |
+ | |||
+ | ==NCCN== | ||
+ | *[https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1491 NCCN Guidelines - Primary Cutaneous Lymphomas] | ||
+ | *[https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1483 NCCN Guidelines - T-cell Lymphomas] | ||
+ | |||
=Upfront therapy= | =Upfront therapy= | ||
==PUVA== | ==PUVA== | ||
Line 26: | Line 33: | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
Line 40: | Line 47: | ||
|2003-2010 | |2003-2010 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
− | |[[#PUVA_. | + | |[[#PUVA_.26_Bexarotene_999|PUVA & Bexarotene]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of ORR | | style="background-color:#ffffbf" |Did not meet primary endpoint of ORR | ||
|- | |- | ||
Line 50: | Line 57: | ||
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
− | # Edelson R, Berger C, Gasparro F, Jegasothy B, Heald P, Wintroub B, Vonderheid E, Knobler R, Wolff K, Plewig G, McKiernan G, Christiansen I, Oster M, Honigsmann H, Wilford H, Kokoschka E, Rehle T, Perez M, Stingl G, Laroche L. Treatment of cutaneous T-cell lymphoma by extracorporeal photochemotherapy: preliminary results. N Engl J Med. 1987 Feb 5;316(6):297-303. [https://doi.org/10.1056/NEJM198702053160603 link to original article] [https://pubmed.ncbi.nlm.nih.gov/3543674 PubMed] | + | # Edelson R, Berger C, Gasparro F, Jegasothy B, Heald P, Wintroub B, Vonderheid E, Knobler R, Wolff K, Plewig G, McKiernan G, Christiansen I, Oster M, Honigsmann H, Wilford H, Kokoschka E, Rehle T, Perez M, Stingl G, Laroche L. Treatment of cutaneous T-cell lymphoma by extracorporeal photochemotherapy: preliminary results. N Engl J Med. 1987 Feb 5;316(6):297-303. [https://doi.org/10.1056/NEJM198702053160603 link to original article] [https://pubmed.ncbi.nlm.nih.gov/3543674/ PubMed] |
− | # '''EORTC 21011:''' Whittaker S, Ortiz P, Dummer R, Ranki A, Hasan B, Meulemans B, Gellrich S, Knobler R, Stadler R, Karrasch M. Efficacy and safety of bexarotene combined with psoralen-ultraviolet A (PUVA) compared with PUVA treatment alone in stage IB-IIA mycosis fungoides: final results from the EORTC Cutaneous Lymphoma Task Force phase III randomized clinical trial (NCT00056056). Br J Dermatol. 2012 Sep;167(3):678-87. [https://doi.org/10.1111/j.1365-2133.2012.11156.x link to original article] [https://pubmed.ncbi.nlm.nih.gov/22924950 PubMed] NCT00056056 | + | # '''EORTC 21011:''' Whittaker S, Ortiz P, Dummer R, Ranki A, Hasan B, Meulemans B, Gellrich S, Knobler R, Stadler R, Karrasch M. Efficacy and safety of bexarotene combined with psoralen-ultraviolet A (PUVA) compared with PUVA treatment alone in stage IB-IIA mycosis fungoides: final results from the EORTC Cutaneous Lymphoma Task Force phase III randomized clinical trial (NCT00056056). Br J Dermatol. 2012 Sep;167(3):678-87. [https://doi.org/10.1111/j.1365-2133.2012.11156.x link to original article] [https://pubmed.ncbi.nlm.nih.gov/22924950/ PubMed] [https://clinicaltrials.gov/study/NCT00056056 NCT00056056] |
+ | |||
==Topical therapy== | ==Topical therapy== | ||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
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{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
Line 65: | Line 73: | ||
|1979-1987 | |1979-1987 | ||
| style="background-color:#1a9851" |Randomized, >20 pts (C) | | style="background-color:#1a9851" |Randomized, >20 pts (C) | ||
− | |[[#CAV-E_. | + | |[[#CAV-E_.26_RT_999|CAV-E & RT]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS60 | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS60 | ||
|- | |- | ||
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</div></div> | </div></div> | ||
===References=== | ===References=== | ||
− | # Kaye FJ, Bunn PA Jr, Steinberg SM, Stocker JL, Ihde DC, Fischmann AB, Glatstein EJ, Schechter GP, Phelps RM, Foss FM, Parlette HL, Anderson MJ, Sausville EA. A randomized trial comparing combination electron-beam radiation and chemotherapy with topical therapy in the initial treatment of mycosis fungoides. N Engl J Med. 1989 Dec 28;321(26):1784-90. [https://doi.org/10.1056/NEJM198912283212603 link to original article] [https://pubmed.ncbi.nlm.nih.gov/2594037 PubMed] | + | # Kaye FJ, Bunn PA Jr, Steinberg SM, Stocker JL, Ihde DC, Fischmann AB, Glatstein EJ, Schechter GP, Phelps RM, Foss FM, Parlette HL, Anderson MJ, Sausville EA. A randomized trial comparing combination electron-beam radiation and chemotherapy with topical therapy in the initial treatment of mycosis fungoides. N Engl J Med. 1989 Dec 28;321(26):1784-90. [https://doi.org/10.1056/NEJM198912283212603 link to original article] [https://pubmed.ncbi.nlm.nih.gov/2594037/ PubMed] |
=Relapsed or refractory= | =Relapsed or refractory= | ||
==Alemtuzumab monotherapy {{#subobject:cd1346|Regimen=1}}== | ==Alemtuzumab monotherapy {{#subobject:cd1346|Regimen=1}}== | ||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:7a3b21|Variant=1}}=== | ===Regimen {{#subobject:7a3b21|Variant=1}}=== | ||
− | {| class="wikitable" style="width: | + | {| class="wikitable sortable" style="width: 80%; text-align:center;" |
− | !style="width: | + | !style="width: 25%"|Study |
− | !style="width: | + | !style="width: 25%"|Dates of enrollment |
− | !style="width: | + | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] |
+ | !style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | ||
|- | |- | ||
− | |[ | + | |[https://doi.org/10.1182/blood-2002-09-2802 Lundin et al. 2003] |
+ | |NR | ||
|style="background-color:#91cf61"|Phase 2 | |style="background-color:#91cf61"|Phase 2 | ||
| style="background-color:#9ebcda" |ORR: 55% | | style="background-color:#9ebcda" |ORR: 55% | ||
Line 93: | Line 103: | ||
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
− | # Lundin J, Hagberg H, Repp R, Cavallin-Ståhl E, Fredén S, Juliusson G, Rosenblad E, Tjønnfjord G, Wiklund T, Osterborg A. Phase 2 study of alemtuzumab (anti-CD52 monoclonal antibody) in patients with advanced mycosis fungoides/Sezary syndrome. Blood. 2003 Jun 1;101(11):4267-72. Epub 2003 Jan 23. [ | + | # Lundin J, Hagberg H, Repp R, Cavallin-Ståhl E, Fredén S, Juliusson G, Rosenblad E, Tjønnfjord G, Wiklund T, Osterborg A. Phase 2 study of alemtuzumab (anti-CD52 monoclonal antibody) in patients with advanced mycosis fungoides/Sezary syndrome. Blood. 2003 Jun 1;101(11):4267-72. Epub 2003 Jan 23. [https://doi.org/10.1182/blood-2002-09-2802 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/12543862/ PubMed] |
==Belinostat monotherapy {{#subobject:f8519|Regimen=1}}== | ==Belinostat monotherapy {{#subobject:f8519|Regimen=1}}== | ||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
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</div></div> | </div></div> | ||
===References=== | ===References=== | ||
− | <!-- # '''Abstract:''' Pohlman, Brad, Advani, Ranjana, Duvic, Madeleine, Hymes, Kenneth B., Intragumtornchai, Tanin, Lekhakula, Arnuparp, Shpilberg, Ofer, Lerner, Adam, Ben-Yehuda, Dina, beylot-Barry, Marie, Hillen, Uwe, Fagerberg, Jan, Foss, Francine M. Final Results of a Phase II Trial of Belinostat (PXD101) in Patients with Recurrent or Refractory Peripheral or Cutaneous T-Cell Lymphoma. ASH Annual Meeting Abstracts 2009 114: 920. | + | <!-- # '''Abstract:''' Pohlman, Brad, Advani, Ranjana, Duvic, Madeleine, Hymes, Kenneth B., Intragumtornchai, Tanin, Lekhakula, Arnuparp, Shpilberg, Ofer, Lerner, Adam, Ben-Yehuda, Dina, beylot-Barry, Marie, Hillen, Uwe, Fagerberg, Jan, Foss, Francine M. Final Results of a Phase II Trial of Belinostat (PXD101) in Patients with Recurrent or Refractory Peripheral or Cutaneous T-Cell Lymphoma. ASH Annual Meeting Abstracts 2009 114: 920.--> |
− | # '''PXD101-CLN-6:''' Foss F, Advani R, Duvic M, Hymes KB, Intragumtornchai T, Lekhakula A, Shpilberg O, Lerner A, Belt RJ, Jacobsen ED, Laurent G, Ben-Yehuda D, Beylot-Barry M, Hillen U, Knoblauch P, Bhat G, Chawla S, Allen LF, Pohlman B. A phase II trial of belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma. Br J Haematol. 2015 Mar;168(6):811-9. Epub 2014 Nov 17. [https://doi.org/10.1111/bjh.13222 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/25404094 PubMed] NCT00274651 | + | # '''PXD101-CLN-6:''' Foss F, Advani R, Duvic M, Hymes KB, Intragumtornchai T, Lekhakula A, Shpilberg O, Lerner A, Belt RJ, Jacobsen ED, Laurent G, Ben-Yehuda D, Beylot-Barry M, Hillen U, Knoblauch P, Bhat G, Chawla S, Allen LF, Pohlman B. A phase II trial of belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma. Br J Haematol. 2015 Mar;168(6):811-9. Epub 2014 Nov 17. [https://doi.org/10.1111/bjh.13222 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/25404094/ PubMed] [https://clinicaltrials.gov/study/NCT00274651 NCT00274651] |
==Bendamustine monotherapy {{#subobject:1a5a99|Regimen=1}}== | ==Bendamustine monotherapy {{#subobject:1a5a99|Regimen=1}}== | ||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
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</div></div> | </div></div> | ||
===References=== | ===References=== | ||
− | # '''BENTLY:''' Damaj G, Gressin R, Bouabdallah K, Cartron G, Choufi B, Gyan E, Banos A, Jaccard A, Park S, Tournilhac O, Schiano-de Collela JM, Voillat L, Joly B, Le Gouill S, Saad A, Cony-Makhoul P, Vilque JP, Sanhes L, Schmidt-Tanguy A, Bubenheim M, Houot R, Diouf M, Marolleau JP, Béné MC, Martin A, Lamy T. Results from a prospective, open-label, phase II trial of bendamustine in refractory or relapsed T-cell lymphomas: the BENTLY trial. J Clin Oncol. 2013 Jan 1;31(1):104-10. Epub 2012 Oct 29. [https://doi.org/10.1200/jco.2012.43.7285 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/23109692 PubMed] NCT00959686 | + | # '''BENTLY:''' Damaj G, Gressin R, Bouabdallah K, Cartron G, Choufi B, Gyan E, Banos A, Jaccard A, Park S, Tournilhac O, Schiano-de Collela JM, Voillat L, Joly B, Le Gouill S, Saad A, Cony-Makhoul P, Vilque JP, Sanhes L, Schmidt-Tanguy A, Bubenheim M, Houot R, Diouf M, Marolleau JP, Béné MC, Martin A, Lamy T. Results from a prospective, open-label, phase II trial of bendamustine in refractory or relapsed T-cell lymphomas: the BENTLY trial. J Clin Oncol. 2013 Jan 1;31(1):104-10. Epub 2012 Oct 29. [https://doi.org/10.1200/jco.2012.43.7285 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/23109692/ PubMed] [https://clinicaltrials.gov/study/NCT00959686 NCT00959686] |
==Bexarotene monotherapy {{#subobject:feb851|Regimen=1}}== | ==Bexarotene monotherapy {{#subobject:feb851|Regimen=1}}== | ||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
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{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
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{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
Line 174: | Line 184: | ||
| style="background-color:#9ebcda" |ORR: 55% | | style="background-color:#9ebcda" |ORR: 55% | ||
|- | |- | ||
− | |[ | + | |[https://archderm.jamanetwork.com/article.aspx?articleid=478334 Duvic et al. 2001b] |
− | |1997-1998 | + | |1997-02 to 1998-11 |
|style="background-color:#1a9851"|Phase 2/3 (E-RT-esc) | |style="background-color:#1a9851"|Phase 2/3 (E-RT-esc) | ||
|[[#Bexarotene_monotherapy|Bexarotene]]; 6.5 mg/m<sup>2</sup>/d | |[[#Bexarotene_monotherapy|Bexarotene]]; 6.5 mg/m<sup>2</sup>/d | ||
− | | style="background-color:#1a9850" |Superior ORR | + | | style="background-color:#1a9850" |Superior ORR (primary endpoint) |
|- | |- | ||
|} | |} | ||
Line 187: | Line 197: | ||
'''Continued indefinitely''' | '''Continued indefinitely''' | ||
</div></div> | </div></div> | ||
+ | |||
===References=== | ===References=== | ||
− | # Duvic M, Hymes K, Heald P, Breneman D, Martin AG, Myskowski P, Crowley C, Yocum RC; Bexarotene Worldwide Study Group. Bexarotene is effective and safe for treatment of refractory advanced-stage cutaneous T-cell lymphoma: multinational phase II-III trial results. J Clin Oncol. 2001 May 1;19(9):2456-71. [https://doi.org/10.1200/jco.2001.19.9.2456 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/11331325 PubMed] | + | # Duvic M, Hymes K, Heald P, Breneman D, Martin AG, Myskowski P, Crowley C, Yocum RC; Bexarotene Worldwide Study Group. Bexarotene is effective and safe for treatment of refractory advanced-stage cutaneous T-cell lymphoma: multinational phase II-III trial results. J Clin Oncol. 2001 May 1;19(9):2456-71. [https://doi.org/10.1200/jco.2001.19.9.2456 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/11331325/ PubMed] |
− | # Duvic M, Martin AG, Kim Y, Olsen E, Wood GS, Crowley CA, Yocum RC; Worldwide Bexarotene Study Group. Phase 2 and 3 clinical trial of oral bexarotene (Targretin capsules) for the treatment of refractory or persistent early-stage cutaneous T-cell lymphoma. Arch Dermatol. 2001 May;137(5):581-93. [ | + | # Duvic M, Martin AG, Kim Y, Olsen E, Wood GS, Crowley CA, Yocum RC; Worldwide Bexarotene Study Group. Phase 2 and 3 clinical trial of oral bexarotene (Targretin capsules) for the treatment of refractory or persistent early-stage cutaneous T-cell lymphoma. Arch Dermatol. 2001 May;137(5):581-93. [https://archderm.jamanetwork.com/article.aspx?articleid=478334 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/11346336/ PubMed] |
− | # '''ALCANZA:''' Prince HM, Kim YH, Horwitz SM, Dummer R, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Sanches JA, Ortiz-Romero PL, Akilov OE, Geskin L, Trotman J, Taylor K, Dalle S, Weichenthal M, Walewski J, Fisher D, Dréno B, Stadler R, Feldman T, Kuzel TM, Wang Y, Palanca-Wessels MC, Zagadailov E, Trepicchio WL, Zhang W, Lin HM, Liu Y, Huebner D, Little M, Whittaker S, Duvic M; ALCANZA study group. Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial. Lancet. 2017 Aug 5;390(10094):555-566. Epub 2017 Jun 7. [https://doi.org/10.1016/S0140-6736(17)31266-7 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28600132 PubMed] NCT01578499 | + | # '''ALCANZA:''' Prince HM, Kim YH, Horwitz SM, Dummer R, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Sanches JA, Ortiz-Romero PL, Akilov OE, Geskin L, Trotman J, Taylor K, Dalle S, Weichenthal M, Walewski J, Fisher D, Dréno B, Stadler R, Feldman T, Kuzel TM, Wang Y, Palanca-Wessels MC, Zagadailov E, Trepicchio WL, Zhang W, Lin HM, Liu Y, Huebner D, Little M, Whittaker S, Duvic M; ALCANZA study group. Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial. Lancet. 2017 Aug 5;390(10094):555-566. Epub 2017 Jun 7. [https://doi.org/10.1016/S0140-6736(17)31266-7 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28600132/ PubMed] [https://clinicaltrials.gov/study/NCT01578499 NCT01578499] |
− | ##'''Update:''' Horwitz SM, Scarisbrick JJ, Dummer R, Whittaker S, Duvic M, Kim YH, Quaglino P, Zinzani PL, Bechter O, Eradat H, Pinter-Brown L, Akilov OE, Geskin L, Sanches JA, Ortiz-Romero PL, Weichenthal M, Fisher DC, Walewski J, Trotman J, Taylor K, Dalle S, Stadler R, Lisano J, Bunn V, Little M, Prince HM. Randomized phase 3 ALCANZA study of brentuximab vedotin vs physician's choice in cutaneous T-cell lymphoma: final data. Blood Adv. 2021 Dec 14;5(23):5098-5106. [https://doi.org/10.1182/bloodadvances.2021004710 link to original article] [ | + | ##'''Update:''' Horwitz SM, Scarisbrick JJ, Dummer R, Whittaker S, Duvic M, Kim YH, Quaglino P, Zinzani PL, Bechter O, Eradat H, Pinter-Brown L, Akilov OE, Geskin L, Sanches JA, Ortiz-Romero PL, Weichenthal M, Fisher DC, Walewski J, Trotman J, Taylor K, Dalle S, Stadler R, Lisano J, Bunn V, Little M, Prince HM. Randomized phase 3 ALCANZA study of brentuximab vedotin vs physician's choice in cutaneous T-cell lymphoma: final data. Blood Adv. 2021 Dec 14;5(23):5098-5106. [https://doi.org/10.1182/bloodadvances.2021004710 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc9153035/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/34507350/ PubMed] |
==Bexarotene & Pralatrexate {{#subobject:8d4e8d|Regimen=1}}== | ==Bexarotene & Pralatrexate {{#subobject:8d4e8d|Regimen=1}}== | ||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
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{| class="wikitable sortable" style="width: 80%; text-align:center;" | {| class="wikitable sortable" style="width: 80%; text-align:center;" | ||
!style="width: 25%"|Study | !style="width: 25%"|Study | ||
− | !style="width: 25%"| | + | !style="width: 25%"|Dates of enrollment |
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | !style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | ||
Line 210: | Line 221: | ||
<div class="toccolours" style="background-color:#b3e2cd"> | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
− | *[[Bexarotene (Targretin)]] 150 mg/m<sup>2</sup> PO once per day | + | *[[Bexarotene (Targretin)]] 150 mg/m<sup>2</sup> PO once per day on days 1 to 28 |
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Pralatrexate (Folotyn)]] 15 mg/m<sup>2</sup> IV once per day on days 1, 8, 15 | *[[Pralatrexate (Folotyn)]] 15 mg/m<sup>2</sup> IV once per day on days 1, 8, 15 | ||
Line 216: | Line 227: | ||
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
− | # '''PDX-018:''' Duvic M, Kim YH, Zinzani PL, Horwitz SM. Results from a phase I/II open-label, dose-finding study of pralatrexate and oral bexarotene in patients with relapsed/refractory cutaneous T-cell lymphoma. Clin Cancer Res. 2017 Jul;23(14):3552-6. Epub 2017 Feb 6. [ | + | # '''PDX-018:''' Duvic M, Kim YH, Zinzani PL, Horwitz SM. Results from a phase I/II open-label, dose-finding study of pralatrexate and oral bexarotene in patients with relapsed/refractory cutaneous T-cell lymphoma. Clin Cancer Res. 2017 Jul;23(14):3552-6. Epub 2017 Feb 6. [https://doi.org/10.1158/1078-0432.ccr-16-2064 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5511551/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28167509/ PubMed] [https://clinicaltrials.gov/study/NCT01134341 NCT01134341] |
==Brentuximab vedotin monotherapy {{#subobject:2781ab|Regimen=1}}== | ==Brentuximab vedotin monotherapy {{#subobject:2781ab|Regimen=1}}== | ||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
Line 222: | Line 233: | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
Line 243: | Line 254: | ||
|style="background-color:#1a9851"|Phase 3 (E-RT-switch-ooc) | |style="background-color:#1a9851"|Phase 3 (E-RT-switch-ooc) | ||
|Investigator's choice of:<br>1a. [[#Bexarotene_monotherapy|Bexarotene]]<br>1b. [[#Methotrexate_monotherapy|Methotrexate]] | |Investigator's choice of:<br>1a. [[#Bexarotene_monotherapy|Bexarotene]]<br>1b. [[#Methotrexate_monotherapy|Methotrexate]] | ||
− | |style="background-color:#1a9850"|Superior PFS<sup>1</sup><br>Median PFS: 16.7 vs 3.5 mo<br>(HR 0.27, 95% CI 0.17-0.43) | + | |style="background-color:#1a9850"|Superior PFS<sup>1</sup> (secondary endpoint)<br>Median PFS: 16.7 vs 3.5 mo<br>(HR 0.27, 95% CI 0.17-0.43)<br><br>Superior objective global response lasting at least 4 months (primary endpoint) |
|- | |- | ||
|} | |} | ||
Line 255: | Line 266: | ||
===References=== | ===References=== | ||
<!-- Presented in part at the 54th Annual Meeting of the American Society of Hematology, December 8-11, 2012, Atlanta, GA, the 56th Annual Meeting of the American Society of Hematology, December 6-9, 2014, San Francisco, CA, and the 72nd Annual Meeting of the Society for Investigative Dermatology, May 9-12, 2012, Raleigh, NC. --> | <!-- Presented in part at the 54th Annual Meeting of the American Society of Hematology, December 8-11, 2012, Atlanta, GA, the 56th Annual Meeting of the American Society of Hematology, December 6-9, 2014, San Francisco, CA, and the 72nd Annual Meeting of the Society for Investigative Dermatology, May 9-12, 2012, Raleigh, NC. --> | ||
− | # '''SU-06212011-7946:''' Kim YH, Tavallaee M, Sundram U, Salva KA, Wood GS, Li S, Rozati S, Nagpal S, Krathen M, Reddy S, Hoppe RT, Nguyen-Lin A, Weng WK, Armstrong R, Pulitzer M, Advani RH, Horwitz SM. Phase II investigator-initiated study of brentuximab vedotin in mycosis fungoides and Sézary syndrome with variable CD30 expression level: A multi-institution collaborative project. J Clin Oncol. 2015 Nov 10;33(32):3750-8. Epub 2015 Jul 20. [https://doi.org/10.1200/jco.2014.60.3969 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5089160/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26195720 PubMed] NCT01396070 | + | # '''SU-06212011-7946:''' Kim YH, Tavallaee M, Sundram U, Salva KA, Wood GS, Li S, Rozati S, Nagpal S, Krathen M, Reddy S, Hoppe RT, Nguyen-Lin A, Weng WK, Armstrong R, Pulitzer M, Advani RH, Horwitz SM. Phase II investigator-initiated study of brentuximab vedotin in mycosis fungoides and Sézary syndrome with variable CD30 expression level: A multi-institution collaborative project. J Clin Oncol. 2015 Nov 10;33(32):3750-8. Epub 2015 Jul 20. [https://doi.org/10.1200/jco.2014.60.3969 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5089160/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26195720/ PubMed] [https://clinicaltrials.gov/study/NCT01396070 NCT01396070] |
<!-- Presented in part at the 54th Annual Meeting of the American Society of Hematology, Atlanta, GA, December 8-11, 2012; the 55th Annual Meeting of the American Society of Hematology, New Orleans, LA, December 7-10, 2013; the 75th Annual Meeting of the Society of Investigative Dermatology, Raleigh, NC, May 9-12, 2012; the International Investigative Dermatology Meeting, Edinburgh, United Kingdom, May 8-11, 2013; the 2nd World Congress Cutaneous Lymphoma, Berlin, Germany, February 6-9, 2013; and the 6th Annual T-Cell Lymphoma Forum, San Francisco, CA, January 23-25, 2014. --> | <!-- Presented in part at the 54th Annual Meeting of the American Society of Hematology, Atlanta, GA, December 8-11, 2012; the 55th Annual Meeting of the American Society of Hematology, New Orleans, LA, December 7-10, 2013; the 75th Annual Meeting of the Society of Investigative Dermatology, Raleigh, NC, May 9-12, 2012; the International Investigative Dermatology Meeting, Edinburgh, United Kingdom, May 8-11, 2013; the 2nd World Congress Cutaneous Lymphoma, Berlin, Germany, February 6-9, 2013; and the 6th Annual T-Cell Lymphoma Forum, San Francisco, CA, January 23-25, 2014. --> | ||
− | # '''MDACC 2010-0914:''' Duvic M, Tetzlaff MT, Gangar P, Clos AL, Sui D, Talpur R. Results of a phase II trial of brentuximab vedotin for CD30+ cutaneous T-cell lymphoma and lymphomatoid papulosis. J Clin Oncol. 2015 Nov 10;33(32):3759-65. Epub 2015 Aug 10. [https://doi.org/10.1200/jco.2014.60.3787 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4737859/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26261247 PubMed] NCT01352520 | + | # '''MDACC 2010-0914:''' Duvic M, Tetzlaff MT, Gangar P, Clos AL, Sui D, Talpur R. Results of a phase II trial of brentuximab vedotin for CD30+ cutaneous T-cell lymphoma and lymphomatoid papulosis. J Clin Oncol. 2015 Nov 10;33(32):3759-65. Epub 2015 Aug 10. [https://doi.org/10.1200/jco.2014.60.3787 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4737859/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26261247/ PubMed] [https://clinicaltrials.gov/study/NCT01352520 NCT01352520] |
− | # '''ALCANZA:''' Prince HM, Kim YH, Horwitz SM, Dummer R, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Sanches JA, Ortiz-Romero PL, Akilov OE, Geskin L, Trotman J, Taylor K, Dalle S, Weichenthal M, Walewski J, Fisher D, Dréno B, Stadler R, Feldman T, Kuzel TM, Wang Y, Palanca-Wessels MC, Zagadailov E, Trepicchio WL, Zhang W, Lin HM, Liu Y, Huebner D, Little M, Whittaker S, Duvic M; ALCANZA study group. Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial. Lancet. 2017 Aug 5;390(10094):555-566. Epub 2017 Jun 7. [https://doi.org/10.1016/S0140-6736(17)31266-7 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28600132 PubMed] NCT01578499 | + | # '''ALCANZA:''' Prince HM, Kim YH, Horwitz SM, Dummer R, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Sanches JA, Ortiz-Romero PL, Akilov OE, Geskin L, Trotman J, Taylor K, Dalle S, Weichenthal M, Walewski J, Fisher D, Dréno B, Stadler R, Feldman T, Kuzel TM, Wang Y, Palanca-Wessels MC, Zagadailov E, Trepicchio WL, Zhang W, Lin HM, Liu Y, Huebner D, Little M, Whittaker S, Duvic M; ALCANZA study group. Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial. Lancet. 2017 Aug 5;390(10094):555-566. Epub 2017 Jun 7. [https://doi.org/10.1016/S0140-6736(17)31266-7 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28600132/ PubMed] [https://clinicaltrials.gov/study/NCT01578499 NCT01578499] |
− | ##'''Update:''' Horwitz SM, Scarisbrick JJ, Dummer R, Whittaker S, Duvic M, Kim YH, Quaglino P, Zinzani PL, Bechter O, Eradat H, Pinter-Brown L, Akilov OE, Geskin L, Sanches JA, Ortiz-Romero PL, Weichenthal M, Fisher DC, Walewski J, Trotman J, Taylor K, Dalle S, Stadler R, Lisano J, Bunn V, Little M, Prince HM. Randomized phase 3 ALCANZA study of brentuximab vedotin vs physician's choice in cutaneous T-cell lymphoma: final data. Blood Adv. 2021 Dec 14;5(23):5098-5106. [https://doi.org/10.1182/bloodadvances.2021004710 link to original article] [ | + | ##'''Update:''' Horwitz SM, Scarisbrick JJ, Dummer R, Whittaker S, Duvic M, Kim YH, Quaglino P, Zinzani PL, Bechter O, Eradat H, Pinter-Brown L, Akilov OE, Geskin L, Sanches JA, Ortiz-Romero PL, Weichenthal M, Fisher DC, Walewski J, Trotman J, Taylor K, Dalle S, Stadler R, Lisano J, Bunn V, Little M, Prince HM. Randomized phase 3 ALCANZA study of brentuximab vedotin vs physician's choice in cutaneous T-cell lymphoma: final data. Blood Adv. 2021 Dec 14;5(23):5098-5106. [https://doi.org/10.1182/bloodadvances.2021004710 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc9153035/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/34507350/ PubMed] |
==Denileukin diftitox monotherapy {{#subobject:751a63|Regimen=1}}== | ==Denileukin diftitox monotherapy {{#subobject:751a63|Regimen=1}}== | ||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
Line 265: | Line 276: | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
Line 280: | Line 291: | ||
|rowspan=2 style="background-color:#1a9851"|Phase 3 (E-RT-esc) | |rowspan=2 style="background-color:#1a9851"|Phase 3 (E-RT-esc) | ||
|1. [[#Denileukin_diftitox_monotherapy|Denileukin diftitox]]; 9 mcg/kg | |1. [[#Denileukin_diftitox_monotherapy|Denileukin diftitox]]; 9 mcg/kg | ||
− | |style="background-color:#1a9850"|Superior ORR | + | |style="background-color:#1a9850"|Superior ORR (primary endpoint) |
|- | |- | ||
− | |2. [[Cutaneous_T-cell_lymphoma_-_null_regimens# | + | |2. [[Cutaneous_T-cell_lymphoma_-_null_regimens#Placebo_2|Placebo]] |
− | |style="background-color:#1a9850"|Superior PFS | + | |style="background-color:#1a9850"|Superior PFS (secondary endpoint) |
|- | |- | ||
|} | |} | ||
Line 297: | Line 308: | ||
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
− | # '''L4389-10:''' Olsen E, Duvic M, Frankel A, Kim Y, Martin A, Vonderheid E, Jegasothy B, Wood G, Gordon M, Heald P, Oseroff A, Pinter-Brown L, Bowen G, Kuzel T, Fivenson D, Foss F, Glode M, Molina A, Knobler E, Stewart S, Cooper K, Stevens S, Craig F, Reuben J, Bacha P, Nichols J. Pivotal phase III trial of two dose levels of denileukin diftitox for the treatment of cutaneous T-cell lymphoma. J Clin Oncol. 2001 Jan 15;19(2):376-88. [https://doi.org/10.1200/jco.2001.19.2.376 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/11208829 PubMed] | + | # '''L4389-10:''' Olsen E, Duvic M, Frankel A, Kim Y, Martin A, Vonderheid E, Jegasothy B, Wood G, Gordon M, Heald P, Oseroff A, Pinter-Brown L, Bowen G, Kuzel T, Fivenson D, Foss F, Glode M, Molina A, Knobler E, Stewart S, Cooper K, Stevens S, Craig F, Reuben J, Bacha P, Nichols J. Pivotal phase III trial of two dose levels of denileukin diftitox for the treatment of cutaneous T-cell lymphoma. J Clin Oncol. 2001 Jan 15;19(2):376-88. [https://doi.org/10.1200/jco.2001.19.2.376 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/11208829/ PubMed] |
<!-- Presented in part at the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL; and the 44th Annual Meeting of the American Society of Clinical Oncology, May 30-June 3, 2008, Chicago, IL. --> | <!-- Presented in part at the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL; and the 44th Annual Meeting of the American Society of Clinical Oncology, May 30-June 3, 2008, Chicago, IL. --> | ||
− | # '''L4389-11:''' Prince HM, Duvic M, Martin A, Sterry W, Assaf C, Sun Y, Straus D, Acosta M, Negro-Vilar A. Phase III placebo-controlled trial of denileukin diftitox for patients with cutaneous T-cell lymphoma. J Clin Oncol. 2010 Apr 10;28(11):1870-7. Epub 2010 Mar 8. [https://doi.org/10.1200/jco.2009.26.2386 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/20212249 PubMed] NCT00050999 | + | # '''L4389-11:''' Prince HM, Duvic M, Martin A, Sterry W, Assaf C, Sun Y, Straus D, Acosta M, Negro-Vilar A. Phase III placebo-controlled trial of denileukin diftitox for patients with cutaneous T-cell lymphoma. J Clin Oncol. 2010 Apr 10;28(11):1870-7. Epub 2010 Mar 8. [https://doi.org/10.1200/jco.2009.26.2386 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/20212249/ PubMed] [https://clinicaltrials.gov/study/NCT00050999 NCT00050999] |
<!-- Presented in part at the 46th Annual Meeting of the American Society of Clinical Oncology in Chicago, IL, June 4-8, 2010 --> | <!-- Presented in part at the 46th Annual Meeting of the American Society of Clinical Oncology in Chicago, IL, June 4-8, 2010 --> | ||
− | # '''Meta-analysis:''' Duvic M, Geskin L, Prince HM. Duration of response in cutaneous T-cell lymphoma patients treated with denileukin diftitox: results from 3 phase III studies. Clin Lymphoma Myeloma Leuk. 2013 Aug;13(4):377-84. Epub 2013 Jun 14. [ | + | # '''Meta-analysis:''' Duvic M, Geskin L, Prince HM. Duration of response in cutaneous T-cell lymphoma patients treated with denileukin diftitox: results from 3 phase III studies. Clin Lymphoma Myeloma Leuk. 2013 Aug;13(4):377-84. Epub 2013 Jun 14. [https://doi.org/10.1016/j.clml.2013.02.020 link to original article] [https://pubmed.ncbi.nlm.nih.gov/23770157/ PubMed] |
+ | |||
==Lenalidomide monotherapy {{#subobject:d48e4c|Regimen=1}}== | ==Lenalidomide monotherapy {{#subobject:d48e4c|Regimen=1}}== | ||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:2dd505|Variant=1}}=== | ===Regimen {{#subobject:2dd505|Variant=1}}=== | ||
− | {| class="wikitable" style="width: | + | {| class="wikitable sortable" style="width: 80%; text-align:center;" |
− | !style="width: | + | !style="width: 25%"|Study |
− | !style="width: | + | !style="width: 25%"|Dates of enrollment |
− | !style="width: | + | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] |
+ | !style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | ||
|- | |- | ||
− | |[ | + | |[https://doi.org/10.1182/blood-2013-09-525915 Querfeld et al. 2013 (NU 04H5)] |
+ | |2005-2010 | ||
|style="background-color:#91cf61"|Phase 2 | |style="background-color:#91cf61"|Phase 2 | ||
| style="background-color:#8c6bb1" |ORR: 28% | | style="background-color:#8c6bb1" |ORR: 28% | ||
|- | |- | ||
|} | |} | ||
+ | ''Note: dose escalations only occurred if the prior dose was tolerated.'' | ||
<div class="toccolours" style="background-color:#b3e2cd"> | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
*[[Lenalidomide (Revlimid)]] as follows: | *[[Lenalidomide (Revlimid)]] as follows: | ||
**Cycle 1: 10 mg PO once per day on days 1 to 21 | **Cycle 1: 10 mg PO once per day on days 1 to 21 | ||
− | **Cycle 2 | + | **Cycle 2: 15 mg PO once per day on days 1 to 21 |
− | **Cycle 3 | + | **Cycle 3: 20 mg PO once per day on days 1 to 21 |
− | ** | + | **Cycles 4 to 26: 25 mg PO once per day on days 1 to 21 |
'''28-day cycle for up to 26 cycles (2 years)''' | '''28-day cycle for up to 26 cycles (2 years)''' | ||
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
− | # '''NU 04H5:''' Querfeld C, Rosen ST, Guitart J, Duvic M, Kim YH, Dusza SW, Kuzel TM. Results of an open-label multicenter phase II trial of lenalidomide monotherapy in refractory mycosis fungoides and Sezary syndrome. Blood. 2014 Feb 20;123(8):1159-66. Epub 2013 Dec 11. [ | + | # '''NU 04H5:''' Querfeld C, Rosen ST, Guitart J, Duvic M, Kim YH, Dusza SW, Kuzel TM. Results of an open-label multicenter phase II trial of lenalidomide monotherapy in refractory mycosis fungoides and Sezary syndrome. Blood. 2014 Feb 20;123(8):1159-66. Epub 2013 Dec 11. [https://doi.org/10.1182/blood-2013-09-525915 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/24335103/ PubMed] [https://clinicaltrials.gov/study/NCT00466921 NCT00466921] |
+ | |||
==Methotrexate monotherapy {{#subobject:0ff378|Regimen=1}}== | ==Methotrexate monotherapy {{#subobject:0ff378|Regimen=1}}== | ||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
Line 331: | Line 347: | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
Line 347: | Line 363: | ||
<div class="toccolours" style="background-color:#b3e2cd"> | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | *[[Methotrexate (MTX)]] 5 to 50 mg PO once | + | *[[Methotrexate (MTX)]] 5 to 50 mg PO once on day 1 |
− | ''' | + | '''7-day cycle for 48 cycles''' |
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
− | # '''Retrospective:''' Zackheim HS, Kashani-Sabet M, McMillan A. Low-dose methotrexate to treat mycosis fungoides: a retrospective study in 69 patients. J Am Acad Dermatol. 2003 Nov;49(5):873-8. [https://www.jaad.org/article/S0190-9622(03)01591-3 link to original article] [https://pubmed.ncbi.nlm.nih.gov/14576667 PubMed] | + | # '''Retrospective:''' Zackheim HS, Kashani-Sabet M, McMillan A. Low-dose methotrexate to treat mycosis fungoides: a retrospective study in 69 patients. J Am Acad Dermatol. 2003 Nov;49(5):873-8. [https://www.jaad.org/article/S0190-9622(03)01591-3 link to original article] [https://pubmed.ncbi.nlm.nih.gov/14576667/ PubMed] |
− | # '''ALCANZA:''' Prince HM, Kim YH, Horwitz SM, Dummer R, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Sanches JA, Ortiz-Romero PL, Akilov OE, Geskin L, Trotman J, Taylor K, Dalle S, Weichenthal M, Walewski J, Fisher D, Dréno B, Stadler R, Feldman T, Kuzel TM, Wang Y, Palanca-Wessels MC, Zagadailov E, Trepicchio WL, Zhang W, Lin HM, Liu Y, Huebner D, Little M, Whittaker S, Duvic M; ALCANZA study group. Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial. Lancet. 2017 Aug 5;390(10094):555-566. Epub 2017 Jun 7. [https://doi.org/10.1016/S0140-6736(17)31266-7 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28600132 PubMed] NCT01578499 | + | # '''ALCANZA:''' Prince HM, Kim YH, Horwitz SM, Dummer R, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Sanches JA, Ortiz-Romero PL, Akilov OE, Geskin L, Trotman J, Taylor K, Dalle S, Weichenthal M, Walewski J, Fisher D, Dréno B, Stadler R, Feldman T, Kuzel TM, Wang Y, Palanca-Wessels MC, Zagadailov E, Trepicchio WL, Zhang W, Lin HM, Liu Y, Huebner D, Little M, Whittaker S, Duvic M; ALCANZA study group. Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial. Lancet. 2017 Aug 5;390(10094):555-566. Epub 2017 Jun 7. [https://doi.org/10.1016/S0140-6736(17)31266-7 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28600132/ PubMed] [https://clinicaltrials.gov/study/NCT01578499 NCT01578499] |
− | ##'''Update:''' Horwitz SM, Scarisbrick JJ, Dummer R, Whittaker S, Duvic M, Kim YH, Quaglino P, Zinzani PL, Bechter O, Eradat H, Pinter-Brown L, Akilov OE, Geskin L, Sanches JA, Ortiz-Romero PL, Weichenthal M, Fisher DC, Walewski J, Trotman J, Taylor K, Dalle S, Stadler R, Lisano J, Bunn V, Little M, Prince HM. Randomized phase 3 ALCANZA study of brentuximab vedotin vs physician's choice in cutaneous T-cell lymphoma: final data. Blood Adv. 2021 Dec 14;5(23):5098-5106. [https://doi.org/10.1182/bloodadvances.2021004710 link to original article] [ | + | ##'''Update:''' Horwitz SM, Scarisbrick JJ, Dummer R, Whittaker S, Duvic M, Kim YH, Quaglino P, Zinzani PL, Bechter O, Eradat H, Pinter-Brown L, Akilov OE, Geskin L, Sanches JA, Ortiz-Romero PL, Weichenthal M, Fisher DC, Walewski J, Trotman J, Taylor K, Dalle S, Stadler R, Lisano J, Bunn V, Little M, Prince HM. Randomized phase 3 ALCANZA study of brentuximab vedotin vs physician's choice in cutaneous T-cell lymphoma: final data. Blood Adv. 2021 Dec 14;5(23):5098-5106. [https://doi.org/10.1182/bloodadvances.2021004710 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc9153035/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/34507350/ PubMed] |
==Mogamulizumab monotherapy {{#subobject:8d8ae3|Regimen=1}}== | ==Mogamulizumab monotherapy {{#subobject:8d8ae3|Regimen=1}}== | ||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
Line 367: | Line 383: | ||
<div class="toccolours" style="background-color:#b3e2cd"> | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
− | *[[Mogamulizumab (Poteligeo)]] 1 mg/kg IV once | + | *[[Mogamulizumab (Poteligeo)]] 1 mg/kg IV once on day 1 |
− | ''' | + | '''7-day cycle for 8 cycles''' |
</div></div><br> | </div></div><br> | ||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
Line 378: | Line 394: | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
Line 393: | Line 409: | ||
| style="background-color:#1a9851" |Phase 3 (E-RT-switch-ooc) | | style="background-color:#1a9851" |Phase 3 (E-RT-switch-ooc) | ||
|[[#Vorinostat_monotherapy|Vorinostat]] | |[[#Vorinostat_monotherapy|Vorinostat]] | ||
− | | style="background-color:#1a9850" |Superior PFS | + | | style="background-color:#1a9850" |Superior PFS (primary endpoint) |
|- | |- | ||
|} | |} | ||
Line 405: | Line 421: | ||
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
− | # '''KW-0761-004:''' Ogura M, Ishida T, Hatake K, Taniwaki M, Ando K, Tobinai K, Fujimoto K, Yamamoto K, Miyamoto T, Uike N, Tanimoto M, Tsukasaki K, Ishizawa K, Suzumiya J, Inagaki H, Tamura K, Akinaga S, Tomonaga M, Ueda R. Multicenter phase II study of mogamulizumab (KW-0761), a defucosylated anti-cc chemokine receptor 4 antibody, in patients with relapsed peripheral T-cell lymphoma and cutaneous T-cell lymphoma. J Clin Oncol. 2014 Apr 10;32(11):1157-63. Epub 2014 Mar 10. [https://doi.org/10.1200/jco.2013.52.0924 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/24616310 PubMed] NCT01192984 | + | # '''KW-0761-004:''' Ogura M, Ishida T, Hatake K, Taniwaki M, Ando K, Tobinai K, Fujimoto K, Yamamoto K, Miyamoto T, Uike N, Tanimoto M, Tsukasaki K, Ishizawa K, Suzumiya J, Inagaki H, Tamura K, Akinaga S, Tomonaga M, Ueda R. Multicenter phase II study of mogamulizumab (KW-0761), a defucosylated anti-cc chemokine receptor 4 antibody, in patients with relapsed peripheral T-cell lymphoma and cutaneous T-cell lymphoma. J Clin Oncol. 2014 Apr 10;32(11):1157-63. Epub 2014 Mar 10. [https://doi.org/10.1200/jco.2013.52.0924 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/24616310/ PubMed] [https://clinicaltrials.gov/study/NCT01192984 NCT01192984] |
− | # '''KW-0761-001:''' Duvic M, Pinter-Brown LC, Foss FM, Sokol L, Jorgensen JL, Challagundla P, Dwyer KM, Zhang X, Kurman MR, Ballerini R, Liu L, Kim YH. Phase 1/2 study of mogamulizumab, a defucosylated anti-CCR4 antibody, in previously treated patients with cutaneous T-cell lymphoma. Blood. 2015 Mar 19;125(12):1883-9. Epub 2015 Jan 20. [ | + | # '''KW-0761-001:''' Duvic M, Pinter-Brown LC, Foss FM, Sokol L, Jorgensen JL, Challagundla P, Dwyer KM, Zhang X, Kurman MR, Ballerini R, Liu L, Kim YH. Phase 1/2 study of mogamulizumab, a defucosylated anti-CCR4 antibody, in previously treated patients with cutaneous T-cell lymphoma. Blood. 2015 Mar 19;125(12):1883-9. Epub 2015 Jan 20. [https://doi.org/10.1182/blood-2014-09-600924 link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc4375715/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/25605368/ PubMed] [https://clinicaltrials.gov/study/NCT00888927 NCT00888927] |
− | # '''MAVORIC:''' Kim YH, Bagot M, Pinter-Brown L, Rook AH, Porcu P, Horwitz SM, Whittaker S, Tokura Y, Vermeer M, Zinzani PL, Sokol L, Morris S, Kim EJ, Ortiz-Romero PL, Eradat H, Scarisbrick J, Tsianakas A, Elmets C, Dalle S, Fisher DC, Halwani A, Poligone B, Greer J, Fierro MT, Khot A, Moskowitz AJ, Musiek A, Shustov A, Pro B, Geskin LJ, Dwyer K, Moriya J, Leoni M, Humphrey JS, Hudgens S, Grebennik DO, Tobinai K, Duvic M; MAVORIC Investigators. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018 Sep;19(9):1192-1204. Epub 2018 Aug 9. [https://doi.org/10.1016/S1470-2045(18)30379-6 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/30100375 PubMed] NCT01728805 | + | # '''MAVORIC:''' Kim YH, Bagot M, Pinter-Brown L, Rook AH, Porcu P, Horwitz SM, Whittaker S, Tokura Y, Vermeer M, Zinzani PL, Sokol L, Morris S, Kim EJ, Ortiz-Romero PL, Eradat H, Scarisbrick J, Tsianakas A, Elmets C, Dalle S, Fisher DC, Halwani A, Poligone B, Greer J, Fierro MT, Khot A, Moskowitz AJ, Musiek A, Shustov A, Pro B, Geskin LJ, Dwyer K, Moriya J, Leoni M, Humphrey JS, Hudgens S, Grebennik DO, Tobinai K, Duvic M; MAVORIC Investigators. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018 Sep;19(9):1192-1204. Epub 2018 Aug 9. [https://doi.org/10.1016/S1470-2045(18)30379-6 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/30100375/ PubMed] [https://clinicaltrials.gov/study/NCT01728805 NCT01728805] |
==Pralatrexate monotherapy {{#subobject:1df1c0|Regimen=1}}== | ==Pralatrexate monotherapy {{#subobject:1df1c0|Regimen=1}}== | ||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:ac3b67|Variant=1}}=== | ===Regimen {{#subobject:ac3b67|Variant=1}}=== | ||
− | {| class="wikitable" style="width: | + | {| class="wikitable sortable" style="width: 80%; text-align:center;" |
− | !style="width: | + | !style="width: 25%"|Study |
− | !style="width: | + | !style="width: 25%"|Dates of enrollment |
− | !style="width: | + | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] |
+ | !style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | ||
|- | |- | ||
− | |[ | + | |[https://doi.org/10.1182/blood-2011-11-390211 Horwitz et al. 2012] |
+ | |2007-08 to 2010-10 | ||
|style="background-color:#91cf61"|Phase 2 | |style="background-color:#91cf61"|Phase 2 | ||
|style="background-color:#737373; color:white"|RR: 45% | |style="background-color:#737373; color:white"|RR: 45% | ||
Line 432: | Line 450: | ||
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
− | # Horwitz SM, Kim YH, Foss F, Zain JM, Myskowski PL, Lechowicz MJ, Fisher DC, Shustov AR, Bartlett NL, Delioukina ML, Koutsoukos T, Saunders ME, O'Connor OA, Duvic M. Identification of an active, well-tolerated dose of pralatrexate in patients with relapsed or refractory cutaneous T-cell lymphoma. Blood. 2012 May 3;119(18):4115-22. Epub 2012 Mar 6. [ | + | # Horwitz SM, Kim YH, Foss F, Zain JM, Myskowski PL, Lechowicz MJ, Fisher DC, Shustov AR, Bartlett NL, Delioukina ML, Koutsoukos T, Saunders ME, O'Connor OA, Duvic M. Identification of an active, well-tolerated dose of pralatrexate in patients with relapsed or refractory cutaneous T-cell lymphoma. Blood. 2012 May 3;119(18):4115-22. Epub 2012 Mar 6. [https://doi.org/10.1182/blood-2011-11-390211 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/22394596/ PubMed] |
==Romidepsin monotherapy {{#subobject:b4c097|Regimen=1}}== | ==Romidepsin monotherapy {{#subobject:b4c097|Regimen=1}}== | ||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
Line 438: | Line 456: | ||
{| class="wikitable sortable" style="width: 80%; text-align:center;" | {| class="wikitable sortable" style="width: 80%; text-align:center;" | ||
!style="width: 25%"|Study | !style="width: 25%"|Study | ||
− | !style="width: 25%"| | + | !style="width: 25%"|Dates of enrollment |
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | !style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | ||
|- | |- | ||
− | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2773225/ Piekarz et al. 2009 (NIH 01-C-0049)] | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2773225/ Piekarz et al. 2009 (NIH 01-C-0049<sub>CTCL</sub>)] |
|NR | |NR | ||
|style="background-color:#91cf61"|Phase 2 (RT) | |style="background-color:#91cf61"|Phase 2 (RT) | ||
Line 459: | Line 477: | ||
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
− | # '''NIH 01-C-0049:''' Piekarz RL, Frye R, Turner M, Wright JJ, Allen SL, Kirschbaum MH, Zain J, Prince HM, Leonard JP, Geskin LJ, Reeder C, Joske D, Figg WD, Gardner ER, Steinberg SM, Jaffe ES, Stetler-Stevenson M, Lade S, Fojo AT, Bates SE. Phase II multi-institutional trial of the histone deacetylase inhibitor romidepsin as monotherapy for patients with cutaneous T-cell lymphoma. J Clin Oncol. 2009 Nov 10;27(32):5410-7. Epub 2009 Oct 13. [https://doi.org/10.1200/jco.2008.21.6150 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2773225/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/19826128 PubMed] NCT00007345 | + | # '''NIH 01-C-0049<sub>CTCL</sub>:''' Piekarz RL, Frye R, Turner M, Wright JJ, Allen SL, Kirschbaum MH, Zain J, Prince HM, Leonard JP, Geskin LJ, Reeder C, Joske D, Figg WD, Gardner ER, Steinberg SM, Jaffe ES, Stetler-Stevenson M, Lade S, Fojo AT, Bates SE. Phase II multi-institutional trial of the histone deacetylase inhibitor romidepsin as monotherapy for patients with cutaneous T-cell lymphoma. J Clin Oncol. 2009 Nov 10;27(32):5410-7. Epub 2009 Oct 13. [https://doi.org/10.1200/jco.2008.21.6150 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2773225/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/19826128/ PubMed] [https://clinicaltrials.gov/study/NCT00007345 NCT00007345] |
− | # '''GPI-04-0001:''' Whittaker SJ, Demierre MF, Kim EJ, Rook AH, Lerner A, Duvic M, Scarisbrick J, Reddy S, Robak T, Becker JC, Samtsov A, McCulloch W, Kim YH. Final results from a multicenter, international, pivotal study of romidepsin in refractory cutaneous T-cell lymphoma. J Clin Oncol. 2010 Oct 10;28(29):4485-91. Epub 2010 Aug 9. [https://doi.org/10.1200/jco.2010.28.9066 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/20697094 PubMed] NCT00106431 | + | # '''GPI-04-0001:''' Whittaker SJ, Demierre MF, Kim EJ, Rook AH, Lerner A, Duvic M, Scarisbrick J, Reddy S, Robak T, Becker JC, Samtsov A, McCulloch W, Kim YH. Final results from a multicenter, international, pivotal study of romidepsin in refractory cutaneous T-cell lymphoma. J Clin Oncol. 2010 Oct 10;28(29):4485-91. Epub 2010 Aug 9. [https://doi.org/10.1200/jco.2010.28.9066 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/20697094/ PubMed] [https://clinicaltrials.gov/study/NCT00106431 NCT00106431] |
==Vorinostat monotherapy {{#subobject:6a3a5b|Regimen=1}}== | ==Vorinostat monotherapy {{#subobject:6a3a5b|Regimen=1}}== | ||
Line 471: | Line 489: | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
Line 502: | Line 520: | ||
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
− | # Duvic M, Talpur R, Ni X, Zhang C, Hazarika P, Kelly C, Chiao JH, Reilly JF, Ricker JL, Richon VM, Frankel SR. Phase 2 trial of oral vorinostat (suberoylanilide hydroxamic acid, SAHA) for refractory cutaneous T-cell lymphoma (CTCL). Blood. 2007 Jan 1;109(1):31-9. Epub 2006 Sep 7. Erratum in: Blood. 2007 Jun 15;109(12):5086. [ | + | # Duvic M, Talpur R, Ni X, Zhang C, Hazarika P, Kelly C, Chiao JH, Reilly JF, Ricker JL, Richon VM, Frankel SR. Phase 2 trial of oral vorinostat (suberoylanilide hydroxamic acid, SAHA) for refractory cutaneous T-cell lymphoma (CTCL). Blood. 2007 Jan 1;109(1):31-9. Epub 2006 Sep 7. Erratum in: Blood. 2007 Jun 15;109(12):5086. [https://doi.org/10.1182/blood-2006-06-025999 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1785068/ link to PMC article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/16960145/ PubMed] |
− | # '''Merck 0683-001:''' Olsen EA, Kim YH, Kuzel TM, Pacheco TR, Foss FM, Parker S, Frankel SR, Chen C, Ricker JL, Arduino JM, Duvic M. Phase IIb multicenter trial of vorinostat in patients with persistent, progressive, or treatment refractory cutaneous T-cell lymphoma. J Clin Oncol. 2007 Jul 20;25(21):3109-15. [https://doi.org/10.1200/jco.2006.10.2434 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/17577020 PubMed] NCT00091559 | + | # '''Merck 0683-001:''' Olsen EA, Kim YH, Kuzel TM, Pacheco TR, Foss FM, Parker S, Frankel SR, Chen C, Ricker JL, Arduino JM, Duvic M. Phase IIb multicenter trial of vorinostat in patients with persistent, progressive, or treatment refractory cutaneous T-cell lymphoma. J Clin Oncol. 2007 Jul 20;25(21):3109-15. Epub 2007 Jun 18. [https://doi.org/10.1200/jco.2006.10.2434 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/17577020/ PubMed] [https://clinicaltrials.gov/study/NCT00091559 NCT00091559] |
− | ## '''Update:''' Duvic M, Olsen EA, Breneman D, Pacheco TR, Parker S, Vonderheid EC, Abuav R, Ricker JL, Rizvi S, Chen C, Boileau K, Gunchenko A, Sanz-Rodriguez C, Geskin LJ. Evaluation of the long-term tolerability and clinical benefit of vorinostat in patients with advanced cutaneous T-cell lymphoma. Clin Lymphoma Myeloma. 2009 Dec;9(6):412-6. [https://doi.org/10.3816/clm.2009.n.082 link to original article] [https://pubmed.ncbi.nlm.nih.gov/19951879 PubMed] | + | ## '''Update:''' Duvic M, Olsen EA, Breneman D, Pacheco TR, Parker S, Vonderheid EC, Abuav R, Ricker JL, Rizvi S, Chen C, Boileau K, Gunchenko A, Sanz-Rodriguez C, Geskin LJ. Evaluation of the long-term tolerability and clinical benefit of vorinostat in patients with advanced cutaneous T-cell lymphoma. Clin Lymphoma Myeloma. 2009 Dec;9(6):412-6. [https://doi.org/10.3816/clm.2009.n.082 link to original article] [https://pubmed.ncbi.nlm.nih.gov/19951879/ PubMed] |
− | # '''MAVORIC:''' Kim YH, Bagot M, Pinter-Brown L, Rook AH, Porcu P, Horwitz SM, Whittaker S, Tokura Y, Vermeer M, Zinzani PL, Sokol L, Morris S, Kim EJ, Ortiz-Romero PL, Eradat H, Scarisbrick J, Tsianakas A, Elmets C, Dalle S, Fisher DC, Halwani A, Poligone B, Greer J, Fierro MT, Khot A, Moskowitz AJ, Musiek A, Shustov A, Pro B, Geskin LJ, Dwyer K, Moriya J, Leoni M, Humphrey JS, Hudgens S, Grebennik DO, Tobinai K, Duvic M; MAVORIC Investigators. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018 Sep;19(9):1192-1204. Epub 2018 Aug 9. [https://doi.org/10.1016/S1470-2045(18)30379-6 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/30100375 PubMed] NCT01728805 | + | # '''MAVORIC:''' Kim YH, Bagot M, Pinter-Brown L, Rook AH, Porcu P, Horwitz SM, Whittaker S, Tokura Y, Vermeer M, Zinzani PL, Sokol L, Morris S, Kim EJ, Ortiz-Romero PL, Eradat H, Scarisbrick J, Tsianakas A, Elmets C, Dalle S, Fisher DC, Halwani A, Poligone B, Greer J, Fierro MT, Khot A, Moskowitz AJ, Musiek A, Shustov A, Pro B, Geskin LJ, Dwyer K, Moriya J, Leoni M, Humphrey JS, Hudgens S, Grebennik DO, Tobinai K, Duvic M; MAVORIC Investigators. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018 Sep;19(9):1192-1204. Epub 2018 Aug 9. [https://doi.org/10.1016/S1470-2045(18)30379-6 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/30100375/ PubMed] [https://clinicaltrials.gov/study/NCT01728805 NCT01728805] |
+ | |||
=Relapsed or refractory, subsequent lines of treatment= | =Relapsed or refractory, subsequent lines of treatment= | ||
==Denileukin diftitox monotherapy {{#subobject:bf44d8|Regimen=1}}== | ==Denileukin diftitox monotherapy {{#subobject:bf44d8|Regimen=1}}== | ||
Line 519: | Line 538: | ||
|} | |} | ||
<div class="toccolours" style="background-color:#b3e2cd"> | <div class="toccolours" style="background-color:#b3e2cd"> | ||
− | ==== | + | ====Targeted therapy==== |
*[[Denileukin diftitox (Ontak)]] 18 mcg/kg IV once per day on days 1 to 5 | *[[Denileukin diftitox (Ontak)]] 18 mcg/kg IV once per day on days 1 to 5 | ||
'''21-day cycle for up to 8 cycles''' | '''21-day cycle for up to 8 cycles''' | ||
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
− | # Duvic M, Martin AG, Olsen EA, Fivenson DP, Prince HM. Efficacy and safety of denileukin diftitox retreatment in patients with relapsed cutaneous T-cell lymphoma. Leuk Lymphoma. 2013 Mar;54(3):514-9. Epub 2012 Sep 3. [https://doi.org/10.3109/10428194.2012.720372 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/22891708 PubMed] | + | # Duvic M, Martin AG, Olsen EA, Fivenson DP, Prince HM. Efficacy and safety of denileukin diftitox retreatment in patients with relapsed cutaneous T-cell lymphoma. Leuk Lymphoma. 2013 Mar;54(3):514-9. Epub 2012 Sep 3. [https://doi.org/10.3109/10428194.2012.720372 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/22891708/ PubMed] |
+ | |||
+ | =Consolidation, all lines of therapy= | ||
+ | ==Busulfan & Fludarabine, then allo HSCT {{#subobject:3fe0f0|Regimen=1}}== | ||
+ | BuFlu: '''<u>Bu</u>'''sulfan & '''<u>Flu</u>'''darabine | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen {{#subobject:a7e574|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
+ | !style="width: 20%"|Study | ||
+ | !style="width: 20%"|Dates of enrollment | ||
+ | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | !style="width: 20%"|Comparator | ||
+ | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
+ | |- | ||
+ | |[https://doi.org/10.1016/s0140-6736(23)00329-x de Masson et al. 2023 (CUTALLO)] | ||
+ | |2016-06-01 to 2022-03-03 | ||
+ | | style="background-color:#1a9851" |Propensity score analysis (E-esc) | ||
+ | |No transplant | ||
+ | | style="background-color:#1a9850" |Superior PFS (primary endpoint)<br>Median PFS: 9 vs 3 mo<br>(HR 0.38, 95% CI 0.21-0.69) | ||
+ | |- | ||
+ | |} | ||
+ | {{#lst:Allogeneic HSCT|a7ehw4}} | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | #'''CUTALLO:''' de Masson A, Beylot-Barry M, Ram-Wolff C, Mear JB, Dalle S, d'Incan M, Ingen-Housz-Oro S, Orvain C, Abraham J, Dereure O, Charbonnier A, Cornillon J, Longvert C, Barete S, Boulinguez S, Wierzbicka-Hainaut E, Aubin F, Rubio MT, Bernard M, Schmidt-Tanguy A, Houot R, Pham-Ledard A, Michonneau D, Brice P, Labussière-Wallet H, Bouaziz JD, Grange F, Moins-Teisserenc H, Jondeau K, Michel L, Mourah S, Battistella M, Daguindau E, Loschi M, Picard A, Franck N, Maillard N, Huynh A, Nguyen S, Marçais A, Chaby G, Ceballos P, Le Corre Y, Maury S, Bay JO, Adamski H, Bachy E, Forcade E, Socié G, Bagot M, Chevret S, Peffault de Latour R; CUTALLO Investigators; Groupe Français d'Etude des Lymphomes Cutanés; Société Française de Greffe de Moëlle et Thérapie Cellulaire. Allogeneic transplantation in advanced cutaneous T-cell lymphomas (CUTALLO): a propensity score matched controlled prospective study. Lancet. 2023 Jun 10;401(10392):1941-1950. Epub 2023 Apr 24. [https://doi.org/10.1016/s0140-6736(23)00329-x link to original article] '''contains dosing details in supplement''' [https://pubmed.ncbi.nlm.nih.gov/37105210/ PubMed] [https://clinicaltrials.gov/study/NCT02520908 NCT02520908] | ||
+ | |||
+ | ==Busulfan, Fludarabine, Thiotepa, then allo HSCT {{#subobject:3ogjc3|Regimen=1}}== | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen {{#subobject:iyrc24|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
+ | !style="width: 20%"|Study | ||
+ | !style="width: 20%"|Dates of enrollment | ||
+ | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | !style="width: 20%"|Comparator | ||
+ | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
+ | |- | ||
+ | |[https://doi.org/10.1016/s0140-6736(23)00329-x de Masson et al. 2023 (CUTALLO)] | ||
+ | |2016-06-01 to 2022-03-03 | ||
+ | | style="background-color:#1a9851" |Propensity score analysis (E-esc) | ||
+ | |No transplant | ||
+ | | style="background-color:#1a9850" |Superior PFS (primary endpoint)<br>Median PFS: 9 vs 3 mo<br>(HR 0.38, 95% CI 0.21-0.69) | ||
+ | |- | ||
+ | |} | ||
+ | {{#lst:Allogeneic HSCT|iyrc24}} | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | #'''CUTALLO:''' de Masson A, Beylot-Barry M, Ram-Wolff C, Mear JB, Dalle S, d'Incan M, Ingen-Housz-Oro S, Orvain C, Abraham J, Dereure O, Charbonnier A, Cornillon J, Longvert C, Barete S, Boulinguez S, Wierzbicka-Hainaut E, Aubin F, Rubio MT, Bernard M, Schmidt-Tanguy A, Houot R, Pham-Ledard A, Michonneau D, Brice P, Labussière-Wallet H, Bouaziz JD, Grange F, Moins-Teisserenc H, Jondeau K, Michel L, Mourah S, Battistella M, Daguindau E, Loschi M, Picard A, Franck N, Maillard N, Huynh A, Nguyen S, Marçais A, Chaby G, Ceballos P, Le Corre Y, Maury S, Bay JO, Adamski H, Bachy E, Forcade E, Socié G, Bagot M, Chevret S, Peffault de Latour R; CUTALLO Investigators; Groupe Français d'Etude des Lymphomes Cutanés; Société Française de Greffe de Moëlle et Thérapie Cellulaire. Allogeneic transplantation in advanced cutaneous T-cell lymphomas (CUTALLO): a propensity score matched controlled prospective study. Lancet. 2023 Jun 10;401(10392):1941-1950. Epub 2023 Apr 24. [https://doi.org/10.1016/s0140-6736(23)00329-x link to original article] '''contains dosing details in supplement''' [https://pubmed.ncbi.nlm.nih.gov/37105210/ PubMed] [https://clinicaltrials.gov/study/NCT02520908 NCT02520908] | ||
+ | |||
+ | ==Fludarabine & Melphalan, then allo HSCT {{#subobject:3fe0f0|Regimen=1}}== | ||
+ | FluMel: '''<u>Flu</u>'''darabine & '''<u>Mel</u>'''phalan | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen {{#subobject:ojnvwc|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
+ | !style="width: 20%"|Study | ||
+ | !style="width: 20%"|Dates of enrollment | ||
+ | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | !style="width: 20%"|Comparator | ||
+ | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
+ | |- | ||
+ | |[https://doi.org/10.1016/s0140-6736(23)00329-x de Masson et al. 2023 (CUTALLO)] | ||
+ | |2016-06-01 to 2022-03-03 | ||
+ | | style="background-color:#1a9851" |Propensity score analysis (E-esc) | ||
+ | |No transplant | ||
+ | | style="background-color:#1a9850" |Superior PFS (primary endpoint)<br>Median PFS: 9 vs 3 mo<br>(HR 0.38, 95% CI 0.21-0.69) | ||
+ | |- | ||
+ | |} | ||
+ | {{#lst:Allogeneic HSCT|ojnvwc}} | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | #'''CUTALLO:''' de Masson A, Beylot-Barry M, Ram-Wolff C, Mear JB, Dalle S, d'Incan M, Ingen-Housz-Oro S, Orvain C, Abraham J, Dereure O, Charbonnier A, Cornillon J, Longvert C, Barete S, Boulinguez S, Wierzbicka-Hainaut E, Aubin F, Rubio MT, Bernard M, Schmidt-Tanguy A, Houot R, Pham-Ledard A, Michonneau D, Brice P, Labussière-Wallet H, Bouaziz JD, Grange F, Moins-Teisserenc H, Jondeau K, Michel L, Mourah S, Battistella M, Daguindau E, Loschi M, Picard A, Franck N, Maillard N, Huynh A, Nguyen S, Marçais A, Chaby G, Ceballos P, Le Corre Y, Maury S, Bay JO, Adamski H, Bachy E, Forcade E, Socié G, Bagot M, Chevret S, Peffault de Latour R; CUTALLO Investigators; Groupe Français d'Etude des Lymphomes Cutanés; Société Française de Greffe de Moëlle et Thérapie Cellulaire. Allogeneic transplantation in advanced cutaneous T-cell lymphomas (CUTALLO): a propensity score matched controlled prospective study. Lancet. 2023 Jun 10;401(10392):1941-1950. Epub 2023 Apr 24. [https://doi.org/10.1016/s0140-6736(23)00329-x link to original article] '''contains dosing details in supplement''' [https://pubmed.ncbi.nlm.nih.gov/37105210/ PubMed] [https://clinicaltrials.gov/study/NCT02520908 NCT02520908] | ||
+ | |||
[[Category:Cutaneous T-cell lymphoma regimens]] | [[Category:Cutaneous T-cell lymphoma regimens]] | ||
[[Category:Disease-specific pages]] | [[Category:Disease-specific pages]] | ||
[[Category:Cutaneous lymphomas]] | [[Category:Cutaneous lymphomas]] | ||
[[Category:T-cell lymphomas]] | [[Category:T-cell lymphomas]] |
Latest revision as of 20:28, 27 June 2024
Section editor | |
---|---|
Bhagirathbhai Dholaria, MBBS Vanderbilt University Nashville, TN, USA |
Are you looking for a regimen but can't find it here? For placebo or observational studies in this condition, please visit this page. If you still can't find it, please let us know so we can add it!
- We have moved How I Treat articles to a dedicated page.
16 regimens on this page
19 variants on this page
|
Guidelines
Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.
ESMO
- 2018: Willemze et al. Primary cutaneous lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up PubMed
- 2013: Willemze et al. Primary cutaneous lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up PubMed
- 2010: Willemze & Dreyling. Primary cutaneous lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up PubMed
- 2009: Willemze & Dreyling. Primary cutaneous lymphoma: ESMO clinical recommendations for diagnosis, treatment and follow-up PubMed
- 2008: Dummer & Dreyling. Primary cutaneous lymphoma: ESMO clinical recommendations for diagnosis, treatment and follow-up PubMed
- 2007: Dummer. Primary cutaneous lymphomas: ESMO clinical recommendations for diagnosis, treatment and follow-up PubMed
NCCN
Upfront therapy
PUVA
PUVA: Psoralen & Ultra-Violet A
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Edelson et al. 1987 | NR | Non-randomized (RT) | ||
Whittaker et al. 2012 (EORTC 21011) | 2003-2010 | Phase 3 (C) | PUVA & Bexarotene | Did not meet primary endpoint of ORR |
Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm.
Chemotherapy
- Methoxsalen (Uvadex) (see papers for details)
References
- Edelson R, Berger C, Gasparro F, Jegasothy B, Heald P, Wintroub B, Vonderheid E, Knobler R, Wolff K, Plewig G, McKiernan G, Christiansen I, Oster M, Honigsmann H, Wilford H, Kokoschka E, Rehle T, Perez M, Stingl G, Laroche L. Treatment of cutaneous T-cell lymphoma by extracorporeal photochemotherapy: preliminary results. N Engl J Med. 1987 Feb 5;316(6):297-303. link to original article PubMed
- EORTC 21011: Whittaker S, Ortiz P, Dummer R, Ranki A, Hasan B, Meulemans B, Gellrich S, Knobler R, Stadler R, Karrasch M. Efficacy and safety of bexarotene combined with psoralen-ultraviolet A (PUVA) compared with PUVA treatment alone in stage IB-IIA mycosis fungoides: final results from the EORTC Cutaneous Lymphoma Task Force phase III randomized clinical trial (NCT00056056). Br J Dermatol. 2012 Sep;167(3):678-87. link to original article PubMed NCT00056056
Topical therapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Kaye et al. 1989 | 1979-1987 | Randomized, >20 pts (C) | CAV-E & RT | Did not meet primary endpoint of OS60 |
Usually consists of high-dose topical steroids or nitrogen mustards; see paper for details.
References
- Kaye FJ, Bunn PA Jr, Steinberg SM, Stocker JL, Ihde DC, Fischmann AB, Glatstein EJ, Schechter GP, Phelps RM, Foss FM, Parlette HL, Anderson MJ, Sausville EA. A randomized trial comparing combination electron-beam radiation and chemotherapy with topical therapy in the initial treatment of mycosis fungoides. N Engl J Med. 1989 Dec 28;321(26):1784-90. link to original article PubMed
Relapsed or refractory
Alemtuzumab monotherapy
Regimen
Study | Dates of enrollment | Evidence | Efficacy |
---|---|---|---|
Lundin et al. 2003 | NR | Phase 2 | ORR: 55% |
Targeted therapy
- Alemtuzumab (Campath) 3 mg IV once on day 1, then increased to 10 mg IV once as soon as infusion-related reactions tolerated, then increased to 30 mg IV once as soon as infusion-related reactions tolerated, then 30 mg IV 3 days per week
Up to 12-week course
References
- Lundin J, Hagberg H, Repp R, Cavallin-Ståhl E, Fredén S, Juliusson G, Rosenblad E, Tjønnfjord G, Wiklund T, Osterborg A. Phase 2 study of alemtuzumab (anti-CD52 monoclonal antibody) in patients with advanced mycosis fungoides/Sezary syndrome. Blood. 2003 Jun 1;101(11):4267-72. Epub 2003 Jan 23. link to original article contains dosing details in abstract PubMed
Belinostat monotherapy
Regimen
Study | Evidence | Efficacy |
---|---|---|
Foss et al. 2014 (PXD101-CLN-6) | Phase 2 | ORR: 14% |
Targeted therapy
- Belinostat (Beleodaq) 1000 mg/m2 IV over 30 minutes once per day on days 1 to 5
21-day cycles
References
- PXD101-CLN-6: Foss F, Advani R, Duvic M, Hymes KB, Intragumtornchai T, Lekhakula A, Shpilberg O, Lerner A, Belt RJ, Jacobsen ED, Laurent G, Ben-Yehuda D, Beylot-Barry M, Hillen U, Knoblauch P, Bhat G, Chawla S, Allen LF, Pohlman B. A phase II trial of belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma. Br J Haematol. 2015 Mar;168(6):811-9. Epub 2014 Nov 17. link to original article contains dosing details in abstract PubMed NCT00274651
Bendamustine monotherapy
Regimen
Study | Evidence | Efficacy |
---|---|---|
Demaj et al. 2013 (BENTLY) | Phase 2 | ORR: 50% |
References
- BENTLY: Damaj G, Gressin R, Bouabdallah K, Cartron G, Choufi B, Gyan E, Banos A, Jaccard A, Park S, Tournilhac O, Schiano-de Collela JM, Voillat L, Joly B, Le Gouill S, Saad A, Cony-Makhoul P, Vilque JP, Sanhes L, Schmidt-Tanguy A, Bubenheim M, Houot R, Diouf M, Marolleau JP, Béné MC, Martin A, Lamy T. Results from a prospective, open-label, phase II trial of bendamustine in refractory or relapsed T-cell lymphomas: the BENTLY trial. J Clin Oncol. 2013 Jan 1;31(1):104-10. Epub 2012 Oct 29. link to original article contains dosing details in manuscript PubMed NCT00959686
Bexarotene monotherapy
Regimen variant #1, 48 weeks
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Prince et al. 2017 (ALCANZA) | 2012-2015 | Phase 3 (C) | Brentuximab vedotin | Inferior PFS1 |
1Reported efficacy is based on the 2021 update.
Note: This dose is considered the target dose in ALCANZA.
Regimen variant #2, indefinite
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Duvic et al. 2001a | 1996-1998 | Phase 2 (RT) | ORR: 55% | |
Duvic et al. 2001b | 1997-02 to 1998-11 | Phase 2/3 (E-RT-esc) | Bexarotene; 6.5 mg/m2/d | Superior ORR (primary endpoint) |
Note: This dose is considered the optimal starting dose by Duvic et al. 2001a.
References
- Duvic M, Hymes K, Heald P, Breneman D, Martin AG, Myskowski P, Crowley C, Yocum RC; Bexarotene Worldwide Study Group. Bexarotene is effective and safe for treatment of refractory advanced-stage cutaneous T-cell lymphoma: multinational phase II-III trial results. J Clin Oncol. 2001 May 1;19(9):2456-71. link to original article contains dosing details in manuscript PubMed
- Duvic M, Martin AG, Kim Y, Olsen E, Wood GS, Crowley CA, Yocum RC; Worldwide Bexarotene Study Group. Phase 2 and 3 clinical trial of oral bexarotene (Targretin capsules) for the treatment of refractory or persistent early-stage cutaneous T-cell lymphoma. Arch Dermatol. 2001 May;137(5):581-93. link to original article contains dosing details in manuscript PubMed
- ALCANZA: Prince HM, Kim YH, Horwitz SM, Dummer R, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Sanches JA, Ortiz-Romero PL, Akilov OE, Geskin L, Trotman J, Taylor K, Dalle S, Weichenthal M, Walewski J, Fisher D, Dréno B, Stadler R, Feldman T, Kuzel TM, Wang Y, Palanca-Wessels MC, Zagadailov E, Trepicchio WL, Zhang W, Lin HM, Liu Y, Huebner D, Little M, Whittaker S, Duvic M; ALCANZA study group. Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial. Lancet. 2017 Aug 5;390(10094):555-566. Epub 2017 Jun 7. link to original article contains dosing details in manuscript PubMed NCT01578499
- Update: Horwitz SM, Scarisbrick JJ, Dummer R, Whittaker S, Duvic M, Kim YH, Quaglino P, Zinzani PL, Bechter O, Eradat H, Pinter-Brown L, Akilov OE, Geskin L, Sanches JA, Ortiz-Romero PL, Weichenthal M, Fisher DC, Walewski J, Trotman J, Taylor K, Dalle S, Stadler R, Lisano J, Bunn V, Little M, Prince HM. Randomized phase 3 ALCANZA study of brentuximab vedotin vs physician's choice in cutaneous T-cell lymphoma: final data. Blood Adv. 2021 Dec 14;5(23):5098-5106. link to original article link to PMC article PubMed
Bexarotene & Pralatrexate
Regimen
Study | Dates of enrollment | Evidence | Efficacy |
---|---|---|---|
Duvic et al. 2017 (PDX-018) | 2010-2015 | Phase 1/2 | ORR: 60% |
Note: This dose is the MTD. Note that the abstract contains a typo for bexarotene dosing; the authors have been contacted.
Targeted therapy
- Bexarotene (Targretin) 150 mg/m2 PO once per day on days 1 to 28
Chemotherapy
- Pralatrexate (Folotyn) 15 mg/m2 IV once per day on days 1, 8, 15
28-day cycles
References
- PDX-018: Duvic M, Kim YH, Zinzani PL, Horwitz SM. Results from a phase I/II open-label, dose-finding study of pralatrexate and oral bexarotene in patients with relapsed/refractory cutaneous T-cell lymphoma. Clin Cancer Res. 2017 Jul;23(14):3552-6. Epub 2017 Feb 6. link to original article contains dosing details in manuscript link to PMC article PubMed NCT01134341
Brentuximab vedotin monotherapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Kim et al. 2015 (SU-06212011-7946) | NR | Phase 2 | OGRR: 70% (90% CI, 53-83) | |
Duvic et al. 2015 (MDACC 2010-0914) | 2011-2013 | Phase 2 | ORR: 73% (95% CI, 60-86) | |
Prince et al. 2017 (ALCANZA) | 2012-2015 | Phase 3 (E-RT-switch-ooc) | Investigator's choice of: 1a. Bexarotene 1b. Methotrexate |
Superior PFS1 (secondary endpoint) Median PFS: 16.7 vs 3.5 mo (HR 0.27, 95% CI 0.17-0.43) Superior objective global response lasting at least 4 months (primary endpoint) |
1Reported efficacy is based on the 2021 update.
Antibody-drug conjugate therapy
- Brentuximab vedotin (Adcetris) 1.8 mg/kg IV over 30 minutes once on day 1
21-day cycle for up to 16 cycles
References
- SU-06212011-7946: Kim YH, Tavallaee M, Sundram U, Salva KA, Wood GS, Li S, Rozati S, Nagpal S, Krathen M, Reddy S, Hoppe RT, Nguyen-Lin A, Weng WK, Armstrong R, Pulitzer M, Advani RH, Horwitz SM. Phase II investigator-initiated study of brentuximab vedotin in mycosis fungoides and Sézary syndrome with variable CD30 expression level: A multi-institution collaborative project. J Clin Oncol. 2015 Nov 10;33(32):3750-8. Epub 2015 Jul 20. link to original article contains dosing details in manuscript link to PMC article PubMed NCT01396070
- MDACC 2010-0914: Duvic M, Tetzlaff MT, Gangar P, Clos AL, Sui D, Talpur R. Results of a phase II trial of brentuximab vedotin for CD30+ cutaneous T-cell lymphoma and lymphomatoid papulosis. J Clin Oncol. 2015 Nov 10;33(32):3759-65. Epub 2015 Aug 10. link to original article contains dosing details in manuscript link to PMC article PubMed NCT01352520
- ALCANZA: Prince HM, Kim YH, Horwitz SM, Dummer R, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Sanches JA, Ortiz-Romero PL, Akilov OE, Geskin L, Trotman J, Taylor K, Dalle S, Weichenthal M, Walewski J, Fisher D, Dréno B, Stadler R, Feldman T, Kuzel TM, Wang Y, Palanca-Wessels MC, Zagadailov E, Trepicchio WL, Zhang W, Lin HM, Liu Y, Huebner D, Little M, Whittaker S, Duvic M; ALCANZA study group. Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial. Lancet. 2017 Aug 5;390(10094):555-566. Epub 2017 Jun 7. link to original article contains dosing details in manuscript PubMed NCT01578499
- Update: Horwitz SM, Scarisbrick JJ, Dummer R, Whittaker S, Duvic M, Kim YH, Quaglino P, Zinzani PL, Bechter O, Eradat H, Pinter-Brown L, Akilov OE, Geskin L, Sanches JA, Ortiz-Romero PL, Weichenthal M, Fisher DC, Walewski J, Trotman J, Taylor K, Dalle S, Stadler R, Lisano J, Bunn V, Little M, Prince HM. Randomized phase 3 ALCANZA study of brentuximab vedotin vs physician's choice in cutaneous T-cell lymphoma: final data. Blood Adv. 2021 Dec 14;5(23):5098-5106. link to original article link to PMC article PubMed
Denileukin diftitox monotherapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Olsen et al. 2001 (L4389-10) | NR | Phase 3 (E-RT-esc) | Denileukin diftitox; 9 mcg/kg | Did not meet primary endpoint of ORR |
Prince et al. 2010 (L4389-11) | NR | Phase 3 (E-RT-esc) | 1. Denileukin diftitox; 9 mcg/kg | Superior ORR (primary endpoint) |
2. Placebo | Superior PFS (secondary endpoint) |
Note: Dose is that which was recommended in L4389-11 based on superior response. Up to 3 additional cycles allowed in L4389-10 for patients who had ongoing response.
Targeted therapy
- Denileukin diftitox (Ontak) 18 mcg/kg IV over 15 to 60 minutes once per day on days 1 to 5
Supportive therapy
- "Premedication with Acetaminophen (Tylenol) (650 mg in Olsen et al. 2001) and an antihistamine was required 30 to 60 minutes before each infusion" and could be used after infusions as needed.
- Olsen et al. 2001 used Promethazine (Phenergan) 25 mg or Prochlorperazine (Compazine) 10 mg (route/schedule not specified) as needed for nausea.
- Corticosteroid use was not allowed.
21-day cycles for up to 8 cycles (see note)
References
- L4389-10: Olsen E, Duvic M, Frankel A, Kim Y, Martin A, Vonderheid E, Jegasothy B, Wood G, Gordon M, Heald P, Oseroff A, Pinter-Brown L, Bowen G, Kuzel T, Fivenson D, Foss F, Glode M, Molina A, Knobler E, Stewart S, Cooper K, Stevens S, Craig F, Reuben J, Bacha P, Nichols J. Pivotal phase III trial of two dose levels of denileukin diftitox for the treatment of cutaneous T-cell lymphoma. J Clin Oncol. 2001 Jan 15;19(2):376-88. link to original article contains dosing details in manuscript PubMed
- L4389-11: Prince HM, Duvic M, Martin A, Sterry W, Assaf C, Sun Y, Straus D, Acosta M, Negro-Vilar A. Phase III placebo-controlled trial of denileukin diftitox for patients with cutaneous T-cell lymphoma. J Clin Oncol. 2010 Apr 10;28(11):1870-7. Epub 2010 Mar 8. link to original article contains dosing details in manuscript PubMed NCT00050999
- Meta-analysis: Duvic M, Geskin L, Prince HM. Duration of response in cutaneous T-cell lymphoma patients treated with denileukin diftitox: results from 3 phase III studies. Clin Lymphoma Myeloma Leuk. 2013 Aug;13(4):377-84. Epub 2013 Jun 14. link to original article PubMed
Lenalidomide monotherapy
Regimen
Study | Dates of enrollment | Evidence | Efficacy |
---|---|---|---|
Querfeld et al. 2013 (NU 04H5) | 2005-2010 | Phase 2 | ORR: 28% |
Note: dose escalations only occurred if the prior dose was tolerated.
Targeted therapy
- Lenalidomide (Revlimid) as follows:
- Cycle 1: 10 mg PO once per day on days 1 to 21
- Cycle 2: 15 mg PO once per day on days 1 to 21
- Cycle 3: 20 mg PO once per day on days 1 to 21
- Cycles 4 to 26: 25 mg PO once per day on days 1 to 21
28-day cycle for up to 26 cycles (2 years)
References
- NU 04H5: Querfeld C, Rosen ST, Guitart J, Duvic M, Kim YH, Dusza SW, Kuzel TM. Results of an open-label multicenter phase II trial of lenalidomide monotherapy in refractory mycosis fungoides and Sezary syndrome. Blood. 2014 Feb 20;123(8):1159-66. Epub 2013 Dec 11. link to original article contains dosing details in manuscript PubMed NCT00466921
Methotrexate monotherapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Prince et al. 2017 (ALCANZA) | 2012-2015 | Phase 3 (C) | Brentuximab vedotin | Inferior PFS1 |
1Reported efficacy is based on the 2021 update.
Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm.
References
- Retrospective: Zackheim HS, Kashani-Sabet M, McMillan A. Low-dose methotrexate to treat mycosis fungoides: a retrospective study in 69 patients. J Am Acad Dermatol. 2003 Nov;49(5):873-8. link to original article PubMed
- ALCANZA: Prince HM, Kim YH, Horwitz SM, Dummer R, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Sanches JA, Ortiz-Romero PL, Akilov OE, Geskin L, Trotman J, Taylor K, Dalle S, Weichenthal M, Walewski J, Fisher D, Dréno B, Stadler R, Feldman T, Kuzel TM, Wang Y, Palanca-Wessels MC, Zagadailov E, Trepicchio WL, Zhang W, Lin HM, Liu Y, Huebner D, Little M, Whittaker S, Duvic M; ALCANZA study group. Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial. Lancet. 2017 Aug 5;390(10094):555-566. Epub 2017 Jun 7. link to original article contains dosing details in manuscript PubMed NCT01578499
- Update: Horwitz SM, Scarisbrick JJ, Dummer R, Whittaker S, Duvic M, Kim YH, Quaglino P, Zinzani PL, Bechter O, Eradat H, Pinter-Brown L, Akilov OE, Geskin L, Sanches JA, Ortiz-Romero PL, Weichenthal M, Fisher DC, Walewski J, Trotman J, Taylor K, Dalle S, Stadler R, Lisano J, Bunn V, Little M, Prince HM. Randomized phase 3 ALCANZA study of brentuximab vedotin vs physician's choice in cutaneous T-cell lymphoma: final data. Blood Adv. 2021 Dec 14;5(23):5098-5106. link to original article link to PMC article PubMed
Mogamulizumab monotherapy
Regimen variant #1, 8-week course
Study | Evidence |
---|---|
Ogura et al. 2014 (KW-0761-004) | Phase 2 |
Regimen variant #2, indefinite
FDA-recommended dose |
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Duvic et al. 2015 (KW-0761-001) | 2009-NR | Phase 1/2 | ||
Kim et al. 2018 (MAVORIC) | 2012-2016 | Phase 3 (E-RT-switch-ooc) | Vorinostat | Superior PFS (primary endpoint) |
Note: in KW-0761-001, a two-week "period of observation" was undertaken after cycle 1.
Targeted therapy
- Mogamulizumab (Poteligeo) as follows:
- Cycle 1: 1 mg/kg IV once per day on days 1, 8, 15, 22
- Cycle 2 onwards: 1 mg/kg IV once per day on days 1 & 15
28-day cycles
References
- KW-0761-004: Ogura M, Ishida T, Hatake K, Taniwaki M, Ando K, Tobinai K, Fujimoto K, Yamamoto K, Miyamoto T, Uike N, Tanimoto M, Tsukasaki K, Ishizawa K, Suzumiya J, Inagaki H, Tamura K, Akinaga S, Tomonaga M, Ueda R. Multicenter phase II study of mogamulizumab (KW-0761), a defucosylated anti-cc chemokine receptor 4 antibody, in patients with relapsed peripheral T-cell lymphoma and cutaneous T-cell lymphoma. J Clin Oncol. 2014 Apr 10;32(11):1157-63. Epub 2014 Mar 10. link to original article contains dosing details in abstract PubMed NCT01192984
- KW-0761-001: Duvic M, Pinter-Brown LC, Foss FM, Sokol L, Jorgensen JL, Challagundla P, Dwyer KM, Zhang X, Kurman MR, Ballerini R, Liu L, Kim YH. Phase 1/2 study of mogamulizumab, a defucosylated anti-CCR4 antibody, in previously treated patients with cutaneous T-cell lymphoma. Blood. 2015 Mar 19;125(12):1883-9. Epub 2015 Jan 20. link to original article contains dosing details in abstract link to PMC article PubMed NCT00888927
- MAVORIC: Kim YH, Bagot M, Pinter-Brown L, Rook AH, Porcu P, Horwitz SM, Whittaker S, Tokura Y, Vermeer M, Zinzani PL, Sokol L, Morris S, Kim EJ, Ortiz-Romero PL, Eradat H, Scarisbrick J, Tsianakas A, Elmets C, Dalle S, Fisher DC, Halwani A, Poligone B, Greer J, Fierro MT, Khot A, Moskowitz AJ, Musiek A, Shustov A, Pro B, Geskin LJ, Dwyer K, Moriya J, Leoni M, Humphrey JS, Hudgens S, Grebennik DO, Tobinai K, Duvic M; MAVORIC Investigators. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018 Sep;19(9):1192-1204. Epub 2018 Aug 9. link to original article contains dosing details in abstract PubMed NCT01728805
Pralatrexate monotherapy
Regimen
Study | Dates of enrollment | Evidence | Efficacy |
---|---|---|---|
Horwitz et al. 2012 | 2007-08 to 2010-10 | Phase 2 | RR: 45% |
Note: Dose is that identified as recommended based on de-escalation strategy.
Chemotherapy
- Pralatrexate (Folotyn) 15 mg/m2 IV push once per day on days 1, 8, 15
Supportive therapy
- Cyanocobalamin (Vitamin B12) 1 mg IM once every 8 to 10 weeks, within 10 weeks of treatment initiation
- Folic acid (Folate) 1 mg PO once per day, starting at least 10 days prior to treatment initiation
28-day cycles
References
- Horwitz SM, Kim YH, Foss F, Zain JM, Myskowski PL, Lechowicz MJ, Fisher DC, Shustov AR, Bartlett NL, Delioukina ML, Koutsoukos T, Saunders ME, O'Connor OA, Duvic M. Identification of an active, well-tolerated dose of pralatrexate in patients with relapsed or refractory cutaneous T-cell lymphoma. Blood. 2012 May 3;119(18):4115-22. Epub 2012 Mar 6. link to original article contains dosing details in manuscript PubMed
Romidepsin monotherapy
Regimen
Study | Dates of enrollment | Evidence | Efficacy |
---|---|---|---|
Piekarz et al. 2009 (NIH 01-C-0049CTCL) | NR | Phase 2 (RT) | ORR: 34% (95% CI, 23-46) |
Whittaker et al. 2010 (GPI-04-0001) | 2005-2007 | Phase 2 (RT) | ORR: 34% (95% CI, 25-45) |
Targeted therapy
- Romidepsin (Istodax) 14 mg/m2 IV over 4 hours once per day on days 1, 8, 15
28-day cycle for up to 6 cycles; optional extension of treatment for patients with SD or better
References
- NIH 01-C-0049CTCL: Piekarz RL, Frye R, Turner M, Wright JJ, Allen SL, Kirschbaum MH, Zain J, Prince HM, Leonard JP, Geskin LJ, Reeder C, Joske D, Figg WD, Gardner ER, Steinberg SM, Jaffe ES, Stetler-Stevenson M, Lade S, Fojo AT, Bates SE. Phase II multi-institutional trial of the histone deacetylase inhibitor romidepsin as monotherapy for patients with cutaneous T-cell lymphoma. J Clin Oncol. 2009 Nov 10;27(32):5410-7. Epub 2009 Oct 13. link to original article contains dosing details in manuscript link to PMC article PubMed NCT00007345
- GPI-04-0001: Whittaker SJ, Demierre MF, Kim EJ, Rook AH, Lerner A, Duvic M, Scarisbrick J, Reddy S, Robak T, Becker JC, Samtsov A, McCulloch W, Kim YH. Final results from a multicenter, international, pivotal study of romidepsin in refractory cutaneous T-cell lymphoma. J Clin Oncol. 2010 Oct 10;28(29):4485-91. Epub 2010 Aug 9. link to original article contains dosing details in manuscript PubMed NCT00106431
Vorinostat monotherapy
Regimen
FDA-recommended dose |
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Duvic et al. 2006 | NR | Phase 2a (RT) | ORR: 24% | |
Olsen et al. 2007 (Merck 0683-001) | NR | Phase 2b (RT) | ORR: 30% | |
Kim et al. 2018 (MAVORIC) | 2012-2016 | Phase 3 (C) | Mogamulizumab | Inferior PFS |
Note: Duvic et al. 2006 evaluated several different doses, but this is the one that "had the most favorable safety profile". To our knowledge, this regimen was not tested as an experimental arm in an RCT prior to becoming a standard comparator arm.
References
- Duvic M, Talpur R, Ni X, Zhang C, Hazarika P, Kelly C, Chiao JH, Reilly JF, Ricker JL, Richon VM, Frankel SR. Phase 2 trial of oral vorinostat (suberoylanilide hydroxamic acid, SAHA) for refractory cutaneous T-cell lymphoma (CTCL). Blood. 2007 Jan 1;109(1):31-9. Epub 2006 Sep 7. Erratum in: Blood. 2007 Jun 15;109(12):5086. link to original article link to PMC article contains dosing details in abstract PubMed
- Merck 0683-001: Olsen EA, Kim YH, Kuzel TM, Pacheco TR, Foss FM, Parker S, Frankel SR, Chen C, Ricker JL, Arduino JM, Duvic M. Phase IIb multicenter trial of vorinostat in patients with persistent, progressive, or treatment refractory cutaneous T-cell lymphoma. J Clin Oncol. 2007 Jul 20;25(21):3109-15. Epub 2007 Jun 18. link to original article contains dosing details in manuscript PubMed NCT00091559
- Update: Duvic M, Olsen EA, Breneman D, Pacheco TR, Parker S, Vonderheid EC, Abuav R, Ricker JL, Rizvi S, Chen C, Boileau K, Gunchenko A, Sanz-Rodriguez C, Geskin LJ. Evaluation of the long-term tolerability and clinical benefit of vorinostat in patients with advanced cutaneous T-cell lymphoma. Clin Lymphoma Myeloma. 2009 Dec;9(6):412-6. link to original article PubMed
- MAVORIC: Kim YH, Bagot M, Pinter-Brown L, Rook AH, Porcu P, Horwitz SM, Whittaker S, Tokura Y, Vermeer M, Zinzani PL, Sokol L, Morris S, Kim EJ, Ortiz-Romero PL, Eradat H, Scarisbrick J, Tsianakas A, Elmets C, Dalle S, Fisher DC, Halwani A, Poligone B, Greer J, Fierro MT, Khot A, Moskowitz AJ, Musiek A, Shustov A, Pro B, Geskin LJ, Dwyer K, Moriya J, Leoni M, Humphrey JS, Hudgens S, Grebennik DO, Tobinai K, Duvic M; MAVORIC Investigators. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018 Sep;19(9):1192-1204. Epub 2018 Aug 9. link to original article contains dosing details in abstract PubMed NCT01728805
Relapsed or refractory, subsequent lines of treatment
Denileukin diftitox monotherapy
Regimen
Study | Evidence |
---|---|
Duvic et al. 2012 | Non-randomized |
Targeted therapy
- Denileukin diftitox (Ontak) 18 mcg/kg IV once per day on days 1 to 5
21-day cycle for up to 8 cycles
References
- Duvic M, Martin AG, Olsen EA, Fivenson DP, Prince HM. Efficacy and safety of denileukin diftitox retreatment in patients with relapsed cutaneous T-cell lymphoma. Leuk Lymphoma. 2013 Mar;54(3):514-9. Epub 2012 Sep 3. link to original article contains dosing details in abstract PubMed
Consolidation, all lines of therapy
Busulfan & Fludarabine, then allo HSCT
BuFlu: Busulfan & Fludarabine
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
de Masson et al. 2023 (CUTALLO) | 2016-06-01 to 2022-03-03 | Propensity score analysis (E-esc) | No transplant | Superior PFS (primary endpoint) Median PFS: 9 vs 3 mo (HR 0.38, 95% CI 0.21-0.69) |
Chemotherapy
- Fludarabine (Fludara) 30 mg/m2 IV once per day for 3 days (days not specified)
- Busulfan (Myleran) 3.2 mg/kg/day IV for 2 days (days not specified)
Immunotherapy
- Allogeneic stem cells transfused on day 0
GVHD prophylaxis
- Cyclosporine started on day -1, tapered on day +90 if no GVHD
- Methotrexate (MTX) 15 mg/m2 IV once on day +1, then 10 mg/m2 IV once per day on days +3, +6, +11
One course
References
- CUTALLO: de Masson A, Beylot-Barry M, Ram-Wolff C, Mear JB, Dalle S, d'Incan M, Ingen-Housz-Oro S, Orvain C, Abraham J, Dereure O, Charbonnier A, Cornillon J, Longvert C, Barete S, Boulinguez S, Wierzbicka-Hainaut E, Aubin F, Rubio MT, Bernard M, Schmidt-Tanguy A, Houot R, Pham-Ledard A, Michonneau D, Brice P, Labussière-Wallet H, Bouaziz JD, Grange F, Moins-Teisserenc H, Jondeau K, Michel L, Mourah S, Battistella M, Daguindau E, Loschi M, Picard A, Franck N, Maillard N, Huynh A, Nguyen S, Marçais A, Chaby G, Ceballos P, Le Corre Y, Maury S, Bay JO, Adamski H, Bachy E, Forcade E, Socié G, Bagot M, Chevret S, Peffault de Latour R; CUTALLO Investigators; Groupe Français d'Etude des Lymphomes Cutanés; Société Française de Greffe de Moëlle et Thérapie Cellulaire. Allogeneic transplantation in advanced cutaneous T-cell lymphomas (CUTALLO): a propensity score matched controlled prospective study. Lancet. 2023 Jun 10;401(10392):1941-1950. Epub 2023 Apr 24. link to original article contains dosing details in supplement PubMed NCT02520908
Busulfan, Fludarabine, Thiotepa, then allo HSCT
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
de Masson et al. 2023 (CUTALLO) | 2016-06-01 to 2022-03-03 | Propensity score analysis (E-esc) | No transplant | Superior PFS (primary endpoint) Median PFS: 9 vs 3 mo (HR 0.38, 95% CI 0.21-0.69) |
Note: this preparative regimen was intended for haploidentical HSCT.
Chemotherapy
- Fludarabine (Fludara) 50 mg/m2 IV once per day for 3 days (days not specified)
- Busulfan (Myleran) 3.2 mg/kg/day IV for 3 days (days not specified)
- Thiotepa (Tepadina) 5 mg/kg IV once (day not specified)
Immunotherapy
- Allogeneic stem cells transfused on day 0
GVHD prophylaxis
- Cyclophosphamide (Cytoxan) 50 mg/kg IV once per day on days +3 & +5
- Cyclosporine started on day -1, tapered on day +90 if no GVHD
- Mycophenolate mofetil (CellCept) 15 mg/kg PO three times per day until day +35
One course
References
- CUTALLO: de Masson A, Beylot-Barry M, Ram-Wolff C, Mear JB, Dalle S, d'Incan M, Ingen-Housz-Oro S, Orvain C, Abraham J, Dereure O, Charbonnier A, Cornillon J, Longvert C, Barete S, Boulinguez S, Wierzbicka-Hainaut E, Aubin F, Rubio MT, Bernard M, Schmidt-Tanguy A, Houot R, Pham-Ledard A, Michonneau D, Brice P, Labussière-Wallet H, Bouaziz JD, Grange F, Moins-Teisserenc H, Jondeau K, Michel L, Mourah S, Battistella M, Daguindau E, Loschi M, Picard A, Franck N, Maillard N, Huynh A, Nguyen S, Marçais A, Chaby G, Ceballos P, Le Corre Y, Maury S, Bay JO, Adamski H, Bachy E, Forcade E, Socié G, Bagot M, Chevret S, Peffault de Latour R; CUTALLO Investigators; Groupe Français d'Etude des Lymphomes Cutanés; Société Française de Greffe de Moëlle et Thérapie Cellulaire. Allogeneic transplantation in advanced cutaneous T-cell lymphomas (CUTALLO): a propensity score matched controlled prospective study. Lancet. 2023 Jun 10;401(10392):1941-1950. Epub 2023 Apr 24. link to original article contains dosing details in supplement PubMed NCT02520908
Fludarabine & Melphalan, then allo HSCT
FluMel: Fludarabine & Melphalan
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
de Masson et al. 2023 (CUTALLO) | 2016-06-01 to 2022-03-03 | Propensity score analysis (E-esc) | No transplant | Superior PFS (primary endpoint) Median PFS: 9 vs 3 mo (HR 0.38, 95% CI 0.21-0.69) |
Chemotherapy
- Fludarabine (Fludara) 30 mg/m2 IV once per day for 3 days (days not specified)
- Melphalan (Alkeran) 140 mg/m2 IV once (day not specified)
Immunotherapy
- Allogeneic stem cells transfused on day 0
GVHD prophylaxis
- Cyclosporine started on day -1, tapered on day +90 if no GVHD
- Methotrexate (MTX) 15 mg/m2 IV once on day +1, then 10 mg/m2 IV once per day on days +3, +6, +11
One course
References
- CUTALLO: de Masson A, Beylot-Barry M, Ram-Wolff C, Mear JB, Dalle S, d'Incan M, Ingen-Housz-Oro S, Orvain C, Abraham J, Dereure O, Charbonnier A, Cornillon J, Longvert C, Barete S, Boulinguez S, Wierzbicka-Hainaut E, Aubin F, Rubio MT, Bernard M, Schmidt-Tanguy A, Houot R, Pham-Ledard A, Michonneau D, Brice P, Labussière-Wallet H, Bouaziz JD, Grange F, Moins-Teisserenc H, Jondeau K, Michel L, Mourah S, Battistella M, Daguindau E, Loschi M, Picard A, Franck N, Maillard N, Huynh A, Nguyen S, Marçais A, Chaby G, Ceballos P, Le Corre Y, Maury S, Bay JO, Adamski H, Bachy E, Forcade E, Socié G, Bagot M, Chevret S, Peffault de Latour R; CUTALLO Investigators; Groupe Français d'Etude des Lymphomes Cutanés; Société Française de Greffe de Moëlle et Thérapie Cellulaire. Allogeneic transplantation in advanced cutaneous T-cell lymphomas (CUTALLO): a propensity score matched controlled prospective study. Lancet. 2023 Jun 10;401(10392):1941-1950. Epub 2023 Apr 24. link to original article contains dosing details in supplement PubMed NCT02520908