Difference between revisions of "Adult T-cell leukemia-lymphoma"
Warner-admin (talk | contribs) m (Text replacement - "font-size:200%"> Hello!<br> We're happy that you've chosen to use HemOnc.org, and hope that you will return often. From now until January 31, we are conducting a survey to learn more about our users and how we can make the site better and more useful.<br> Please help us by filling it out!<br>" to "font-size:300%"> Just 10 days left to fill out a survey on how we can make HemOnc.org better and more useful.<br>") |
Warner-admin (talk | contribs) m (Text replacement - "http://www.ncbi.nlm.nih.gov/pmc" to "https://www.ncbi.nlm.nih.gov/pmc") |
||
(95 intermediate revisions by 4 users not shown) | |||
Line 1: | Line 1: | ||
− | + | <span id="BackToTop"></span> | |
− | + | <div class="noprint" style="background-color:LightGray; position:fixed; bottom:2%; right:0.25%; padding-left:5px; padding-right:5px; margin: 15px; opacity:0.8; border-style: solid; border-color:DarkGray; border-width: 1px"> | |
− | + | [[#top|Back to Top]] | |
− | + | </div> | |
− | </ | + | {{#lst:Editorial board transclusions|tcl}} |
− | |} | + | ''Are you looking for a regimen, but can't find it here? It is possible that we've moved it to the [[Adult T-cell leukemia-lymphoma - historical|historical regimens page]]. |
− | |||
− | |||
− | |||
{| class="wikitable" style="float:right; margin-right: 5px;" | {| class="wikitable" style="float:right; margin-right: 5px;" | ||
|- | |- | ||
− | |<div style="background-color: #fee0d1; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] | + | |<div style="background-color: #fee0d1; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Regimen |limit=10000|format=sum}} [[Tutorial#Regimens|regimens]] on this page</b></font></div> |
− | <div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] | + | <div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Variant |limit=10000|format=sum}} [[Tutorial#Variants|variants]] on this page</b></font></div> |
|} | |} | ||
+ | *''We have moved [[How I Treat]] articles to a dedicated page.'' | ||
{{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.''' |
− | *[https://www.nccn.org/ | + | ==NCCN== |
+ | *''NCCN does not currently have guidelines at this granular level; please see [https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1483 NCCN Guidelines - T-cell Lymphomas].'' | ||
=Untreated= | =Untreated= | ||
− | |||
==CHOP-14 {{#subobject:3e53d9|Regimen=1}}== | ==CHOP-14 {{#subobject:3e53d9|Regimen=1}}== | ||
− | {| class="wikitable" style=" | + | CHOP-14: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''redniso(lo)ne every '''<u>14</u>''' days |
+ | <br>CHOP-DI: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''redniso(lo)ne, '''<u>D</u>'''ose-'''<u>I</u>'''ntense | ||
+ | <br>I-CHOP: '''<u>I</u>'''ntensive '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''redniso(lo)ne | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen {{#subobject:ad2f7b|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
+ | !style="width: 17%"|Study | ||
+ | !style="width: 15%"|Dates of enrollment | ||
+ | !style="width: 17%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | !style="width: 17%"|Comparator | ||
+ | !style="width: 17%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
+ | !style="width: 17%"|[[Levels_of_Evidence#Toxicity|Comparative Toxicity]] | ||
|- | |- | ||
− | |[ | + | |[https://doi.org/10.1093/annonc/mdf287 Itoh et al. 2002 (JCOG 9505)] |
− | + | |1995-1998 | |
− | + | |style="background-color:#1a9851"|Randomized Phase 2 (E-de-esc) | |
− | + | |[[#Dose-escalated_CHOP_999|dose-escalated CHOP]] | |
− | + | | style="background-color:#ffffbf" |Did not meet primary endpoint of CR rate | |
− | + | | style="background-color:#1a9850" |Less toxic | |
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
− | |[ | + | |[https://doi.org/10.1200/jco.2007.11.9958 Tsukasaki et al. 2007 (JCOG 9801)] |
− | |style="background-color:#1a9851"|Phase | + | |1998-2003 |
− | |[[ | + | |style="background-color:#1a9851"|Phase 3 (C) |
− | |style="background-color:# | + | |[[#mLSG15|mLSG15]] |
+ | |style="background-color:#ffffbf"|Did not meet primary endpoint of OS | ||
+ | | style="background-color:#1a9850" |Less toxic | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | *[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | ||
− | *[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> ( | + | *[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 |
+ | ====Glucocorticoid therapy==== | ||
*[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5 | *[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5 | ||
− | + | ====Supportive therapy==== | |
− | ====Supportive | + | *[[Filgrastim (Neupogen)]] given once ANC decreased to less than 1000/μL and continued once per day until count increased to greater than 5000/μL |
− | *[[Filgrastim (Neupogen)]] given once ANC decreased to less than 1000/ | ||
− | |||
'''14-day cycle for 8 cycles''' | '''14-day cycle for 8 cycles''' | ||
− | + | ====CNS therapy==== | |
− | ==== | + | ''Intrathecal triple-therapy was given during recovery phase of cycles 1, 3, and 5 after platelet count was greater than 70 x 10<sup>9</sup>/L.'' |
− | ''Intrathecal triple-therapy was given during recovery phase of cycles 1, 3, and 5 after platelet count was greater than 70 | + | *[[Cytarabine (Ara-C)]] 40 mg IT |
− | *[[Cytarabine ( | ||
*[[Methotrexate (MTX)]] 15 mg IT | *[[Methotrexate (MTX)]] 15 mg IT | ||
*[[Prednisone (Sterapred)]] 10 mg IT | *[[Prednisone (Sterapred)]] 10 mg IT | ||
− | |||
'''3 doses, total''' | '''3 doses, total''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
+ | # '''JCOG 9505:''' Itoh K, Ohtsu T, Fukuda H, Sasaki Y, Ogura M, Morishima Y, Chou T, Aikawa K, Uike N, Mizorogi F, Ohno T, Ikeda S, Sai T, Taniwaki M, Kawano F, Niimi M, Hotta T, Shimoyama M, Tobinai K; [[Study_Groups#JCOG|JCOG]]. Randomized phase II study of biweekly CHOP and dose-escalated CHOP with prophylactic use of lenograstim (glycosylated G-CSF) in aggressive non-Hodgkin's lymphoma: Japan Clinical Oncology Group Study 9505. Ann Oncol. 2002 Sep;13(9):1347-55. [https://doi.org/10.1093/annonc/mdf287 link to original article] [https://pubmed.ncbi.nlm.nih.gov/12196359/ PubMed] | ||
<!-- Presented in part at the 47th Annual Meeting of the American Society of Hematology, December 10-13, 2005, Atlanta, GA. --> | <!-- Presented in part at the 47th Annual Meeting of the American Society of Hematology, December 10-13, 2005, Atlanta, GA. --> | ||
− | # Tsukasaki K, Utsunomiya A, Fukuda H, Shibata T, Fukushima T, Takatsuka Y, Ikeda S, Masuda M, Nagoshi H, Ueda R, Tamura K, Sano M, Momita S, Yamaguchi K, Kawano F, Hanada S, Tobinai K, Shimoyama M, Hotta T, Tomonaga M; | + | # '''JCOG 9801:''' Tsukasaki K, Utsunomiya A, Fukuda H, Shibata T, Fukushima T, Takatsuka Y, Ikeda S, Masuda M, Nagoshi H, Ueda R, Tamura K, Sano M, Momita S, Yamaguchi K, Kawano F, Hanada S, Tobinai K, Shimoyama M, Hotta T, Tomonaga M; [[Study_Groups#JCOG|JCOG]]. VCAP-AMP-VECP compared with biweekly CHOP for adult T-cell leukemia-lymphoma: Japan Clinical Oncology Group Study JCOG9801. J Clin Oncol. 2007 Dec 1;25(34):5458-64. Epub 2007 Oct 29. [https://doi.org/10.1200/jco.2007.11.9958 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/17968021/ PubMed] [https://clinicaltrials.gov/study/NCT00145002 NCT00145002] |
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
==mLSG15 {{#subobject:832886|Regimen=1}}== | ==mLSG15 {{#subobject:832886|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
− | |||
− | |||
− | |||
===Regimen {{#subobject:1dc050|Variant=1}}=== | ===Regimen {{#subobject:1dc050|Variant=1}}=== | ||
− | {| class="wikitable" style="width: 100%; text-align:center;" | + | {| class="wikitable sortable" style="width: 100%; text-align:center;" |
− | !Study | + | !style="width: 20%"|Study |
− | ![[Levels_of_Evidence#Evidence|Evidence]] | + | !style="width: 20%"|Dates of enrollment |
− | !Comparator | + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] |
− | ![[Levels_of_Evidence# | + | !style="width: 20%"|Comparator |
+ | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
− | |[ | + | |[https://doi.org/10.1200/jco.2007.11.9958 Tsukasaki et al. 2007 (JCOG 9801)] |
− | |style="background-color:#1a9851"|Phase | + | |1998-2003 |
− | |[[ | + | |style="background-color:#1a9851"|Phase 3 (E-esc) |
− | |style="background-color:# | + | |[[#CHOP-14|CHOP-14]] |
+ | |style="background-color:#ffffbf"|Did not meet primary endpoint of OS | ||
|- | |- | ||
− | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5024033/ Ishida et al. 2015] | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5024033/ Ishida et al. 2015 (Kyowa 0761-003)] |
− | |style="background-color:#1a9851"|Randomized Phase | + | |2010-2011 |
− | |[[ | + | |style="background-color:#1a9851"|Randomized Phase 2 (C) |
− | |style="background-color:#ffffbf"| | + | |[[#mLSG15_.26_Mogamulizumab_999|mLSG15 & Mogamulizumab]] |
+ | |style="background-color:#ffffbf"|Did not meet primary endpoint of CR rate | ||
|- | |- | ||
|} | |} | ||
− | ''Ranimustine is not available in the United States and is approved only in Japan.'' | + | ''Note: Ranimustine is not available in the United States and is approved only in Japan.'' |
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | *[[Vincristine (Oncovin)]] 1 mg/m<sup>2</sup> (maximum dose | + | *[[Vincristine (Oncovin)]] 1 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 |
*[[Cyclophosphamide (Cytoxan)]] 350 mg/m<sup>2</sup> IV once on day 1 | *[[Cyclophosphamide (Cytoxan)]] 350 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Doxorubicin (Adriamycin)]] 40 mg/m<sup>2</sup> IV once on day 1, then 30 mg/m<sup>2</sup> IV once on day 8 | *[[Doxorubicin (Adriamycin)]] 40 mg/m<sup>2</sup> IV once on day 1, then 30 mg/m<sup>2</sup> IV once on day 8 | ||
− | |||
*[[Ranimustine (Cymerin)]] 60 mg/m<sup>2</sup> IV once on day 8 | *[[Ranimustine (Cymerin)]] 60 mg/m<sup>2</sup> IV once on day 8 | ||
*[[Vindesine (Eldisine)]] 2.4 mg/m<sup>2</sup> IV once on day 15 | *[[Vindesine (Eldisine)]] 2.4 mg/m<sup>2</sup> IV once on day 15 | ||
*[[Etoposide (Vepesid)]] 100 mg/m<sup>2</sup> IV once per day on days 15 to 17 | *[[Etoposide (Vepesid)]] 100 mg/m<sup>2</sup> IV once per day on days 15 to 17 | ||
*[[Carboplatin (Paraplatin)]] 250 mg/m<sup>2</sup> IV once on day 15 | *[[Carboplatin (Paraplatin)]] 250 mg/m<sup>2</sup> IV once on day 15 | ||
− | + | ====Glucocorticoid therapy==== | |
+ | *[[Prednisone (Sterapred)]] 40 mg/m<sup>2</sup> PO once per day on days 1, 8, 15 to 17 | ||
'''28-day cycle for 6 cycles''' | '''28-day cycle for 6 cycles''' | ||
− | + | ====CNS therapy, prophylaxis==== | |
− | ====CNS prophylaxis==== | + | *[[Cytarabine (Ara-C)]] 40 mg IT, admixed with MTX & prednisone |
− | *[[Cytarabine ( | + | *[[Methotrexate (MTX)]] 15 mg IT, admixed with Ara-C & prednisone |
− | + | *[[Prednisone (Sterapred)]] 10 mg IT, admixed with Ara-C & MTX | |
− | '''Given after cycles 1, 3, and 5 after platelets greater than 70 | + | '''Given after cycles 1, 3, and 5 after platelets greater than 70 x 10<sup>9</sup>/L and within 2 days before the next cycle''' |
− | + | </div></div> | |
===References=== | ===References=== | ||
<!-- Presented in part at the 47th Annual Meeting of the American Society of Hematology, December 10-13, 2005, Atlanta, GA. --> | <!-- Presented in part at the 47th Annual Meeting of the American Society of Hematology, December 10-13, 2005, Atlanta, GA. --> | ||
− | # Tsukasaki K, Utsunomiya A, Fukuda H, Shibata T, Fukushima T, Takatsuka Y, Ikeda S, Masuda M, Nagoshi H, Ueda R, Tamura K, Sano M, Momita S, Yamaguchi K, Kawano F, Hanada S, Tobinai K, Shimoyama M, Hotta T, Tomonaga M; | + | #'''JCOG 9801:''' Tsukasaki K, Utsunomiya A, Fukuda H, Shibata T, Fukushima T, Takatsuka Y, Ikeda S, Masuda M, Nagoshi H, Ueda R, Tamura K, Sano M, Momita S, Yamaguchi K, Kawano F, Hanada S, Tobinai K, Shimoyama M, Hotta T, Tomonaga M; [[Study_Groups#JCOG|JCOG]]. VCAP-AMP-VECP compared with biweekly CHOP for adult T-cell leukemia-lymphoma: Japan Clinical Oncology Group Study JCOG9801. J Clin Oncol. 2007 Dec 1;25(34):5458-64. Epub 2007 Oct 29. [https://doi.org/10.1200/jco.2007.11.9958 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/17968021/ PubMed] [https://clinicaltrials.gov/study/NCT00145002 NCT00145002] |
− | # Ishida T, Jo T, Takemoto S, Suzushima H, Uozumi K, Yamamoto K, Uike N, Saburi Y, Nosaka K, Utsunomiya A, Tobinai K, Fujiwara H, Ishitsuka K, Yoshida S, Taira N, Moriuchi Y, Imada K, Miyamoto T, Akinaga S, Tomonaga M, Ueda R. Dose-intensified chemotherapy alone or in combination with mogamulizumab in newly diagnosed aggressive adult T-cell leukaemia-lymphoma: a randomized phase II study. Br J Haematol. 2015 Jun;169(5):672-82. Epub 2015 Mar 2. [ | + | #'''Kyowa 0761-003:''' Ishida T, Jo T, Takemoto S, Suzushima H, Uozumi K, Yamamoto K, Uike N, Saburi Y, Nosaka K, Utsunomiya A, Tobinai K, Fujiwara H, Ishitsuka K, Yoshida S, Taira N, Moriuchi Y, Imada K, Miyamoto T, Akinaga S, Tomonaga M, Ueda R. Dose-intensified chemotherapy alone or in combination with mogamulizumab in newly diagnosed aggressive adult T-cell leukaemia-lymphoma: a randomized phase II study. Br J Haematol. 2015 Jun;169(5):672-82. Epub 2015 Mar 2. [https://doi.org/10.1111/bjh.13338 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5024033/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/25733162/ PubMed] [https://clinicaltrials.gov/study/NCT01173887 NCT01173887] |
=Relapsed or refractory= | =Relapsed or refractory= | ||
− | |||
==Alemtuzumab monotherapy {{#subobject:efc45a|Regimen=1}}== | ==Alemtuzumab monotherapy {{#subobject:efc45a|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
− | |||
− | |||
− | |||
===Regimen {{#subobject:32e392|Variant=1}}=== | ===Regimen {{#subobject:32e392|Variant=1}}=== | ||
− | {| class="wikitable" style="width: | + | {| class="wikitable sortable" style="width: 60%; text-align:center;" |
− | !Study | + | !style="width: 33%"|Study |
− | ![[Levels_of_Evidence#Evidence|Evidence]] | + | !style="width: 33%"|Dates of enrollment |
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
|- | |- | ||
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5215752/ Sharma et al. 2016] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5215752/ Sharma et al. 2016] | ||
− | |style="background-color:#91cf61"|Phase | + | |2004-2009 |
+ | |style="background-color:#91cf61"|Phase 2 | ||
|- | |- | ||
|} | |} | ||
− | ==== | + | ''Note: Scheduling is timed to start on a Monday.'' |
− | *[[Alemtuzumab (Campath)]] 30 mg IV | + | <div class="toccolours" style="background-color:#b3e2cd"> |
− | + | ====Targeted therapy==== | |
− | ''' | + | *[[Alemtuzumab (Campath)]] as follows: |
− | + | **Cycle 1: 3 mg IV once on day 1, then 10 mg IV once on day 2, then 30 mg IV once per day on days 3 & 5 | |
+ | **Cycles 2 to 12: 30 mg IV once per day on days 1, 3, 5 or 2, 4, 6 (three times per week) | ||
+ | ====Supportive therapy==== | ||
+ | *Antibacterial prophylaxis: [[Trimethoprim-Sulfamethoxazole (Bactrim DS)]] 160/80 mg PO three times per week | ||
+ | *Antiviral prophylaxis: [[Famciclovir (Famvir)]] or [[Valganciclovir (Valcyte)]] once per day | ||
+ | *Antifungal prophylaxis: [[Fluconazole (Diflucan)]] | ||
+ | '''7-day cycle for up to 12 cycles''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
<!-- Presented in abstract form at the 50th Annual Meeting of the American Society of Hematology, San Francisco, CA, December 6–9, 2008. --> | <!-- Presented in abstract form at the 50th Annual Meeting of the American Society of Hematology, San Francisco, CA, December 6–9, 2008. --> | ||
− | # Sharma K, Janik JE, O'Mahony D, Stewart D, Pittaluga S, Stetler-Stevenson M, Jaffe ES, Raffeld M, Fleisher TA, Lee CC, Steinberg SM, Waldmann TA, Morris JC. Phase II | + | # Sharma K, Janik JE, O'Mahony D, Stewart D, Pittaluga S, Stetler-Stevenson M, Jaffe ES, Raffeld M, Fleisher TA, Lee CC, Steinberg SM, Waldmann TA, Morris JC. Phase II study of alemtuzumab (CAMPATH-1) in patients with HTLV-1-associated adult T-cell leukemia/lymphoma. Clin Cancer Res. 2017 Jan 1;23(1):35-42. Epub 2016 Aug 2. [http://clincancerres.aacrjournals.org/content/23/1/35.long link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5215752/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/27486175/ PubMed] |
==Lenalidomide monotherapy {{#subobject:b2b90e|Regimen=1}}== | ==Lenalidomide monotherapy {{#subobject:b2b90e|Regimen=1}}== | ||
− | {| class="wikitable" style=" | + | <div class="toccolours" style="background-color:#eeeeee"> |
+ | ===Regimen {{#subobject:662944|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 80%; text-align:center;" | ||
+ | !style="width: 25%"|Study | ||
+ | !style="width: 25%"|Dates of enrollment | ||
+ | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | !style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | ||
+ | |- | ||
+ | |[https://doi.org/10.1200/JCO.2016.67.7732 Ishida et al. 2016 (ATLL-002)] | ||
+ | |2012-2014 | ||
+ | |style="background-color:#91cf61"|Phase 2 | ||
+ | |ORR: 42% (95% CI 23-63) | ||
|- | |- | ||
− | |||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Targeted therapy==== | ||
+ | *[[Lenalidomide (Revlimid)]] 25 mg PO once per day | ||
+ | '''Continued indefinitely''' | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | # '''ATLL-002:''' Ishida T, Fujiwara H, Nosaka K, Taira N, Abe Y, Imaizumi Y, Moriuchi Y, Jo T, Ishizawa K, Tobinai K, Tsukasaki K, Ito S, Yoshimitsu M, Otsuka M, Ogura M, Midorikawa S, Ruiz W, Ohtsu T. Multicenter phase II study of lenalidomide in relapsed or recurrent adult T-cell leukemia/lymphoma: ATLL-002. J Clin Oncol. 2016 Dec;34(34):4086-4093. Epub 2016 Sep 30. [https://doi.org/10.1200/JCO.2016.67.7732 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/27621400/ PubMed] [https://clinicaltrials.gov/study/NCT01724177 NCT01724177] | ||
− | ===Regimen {{#subobject: | + | ==Valemetostat monotherapy {{#subobject:bval0e|Regimen=1}}== |
− | {| class="wikitable" style="width: | + | <div class="toccolours" style="background-color:#eeeeee"> |
− | !Study | + | ===Regimen {{#subobject:6val44|Variant=1}}=== |
− | ![[Levels_of_Evidence#Evidence|Evidence]] | + | {| class="wikitable sortable" style="width: 60%; text-align:center;" |
− | + | !style="width: 33%"|Study | |
+ | !style="width: 33%"|Dates of enrollment | ||
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
|- | |- | ||
− | |[ | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc10651775/ Izutsu et al. 2022 (DS3201-A-J201)] |
− | |style="background-color:#91cf61"|Phase | + | |2019-11 to 2020-10 |
− | + | | style="background-color:#91cf61" |Phase 2 (RT) | |
|- | |- | ||
|} | |} | ||
− | ==== | + | <div class="toccolours" style="background-color:#b3e2cd"> |
− | *[[ | + | ====Targeted therapy==== |
− | + | *[[Valemetostat (Ezharmia)]] 200 mg PO once per day on days 1 to 28, taken at least 2 hours before or at least 1 hour after a meal | |
− | ''' | + | '''28-day cycles''' |
− | + | </div></div> | |
===References=== | ===References=== | ||
− | # | + | #'''DS3201-A-J201:''' Izutsu K, Makita S, Nosaka K, Yoshimitsu M, Utsunomiya A, Kusumoto S, Morishima S, Tsukasaki K, Kawamata T, Ono T, Rai S, Katsuya H, Ishikawa J, Yamada H, Kato K, Tachibana M, Kakurai Y, Adachi N, Tobinai K, Yonekura K, Ishitsuka K. An open-label, single-arm phase 2 trial of valemetostat for relapsed or refractory adult T-cell leukemia/lymphoma. Blood. 2023 Mar 9;141(10):1159-1168. Epub 2022 Sep 27. [https://doi.org/10.1182/blood.2022016862 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc10651775/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/36150143/ PubMed] [https://clinicaltrials.gov/study/NCT04102150 NCT04102150] |
[[Category:Adult T-cell leukemia-lymphoma regimens]] | [[Category:Adult T-cell leukemia-lymphoma regimens]] | ||
Line 201: | Line 194: | ||
[[Category:Acute leukemias]] | [[Category:Acute leukemias]] | ||
[[Category:T-cell lymphomas]] | [[Category:T-cell lymphomas]] | ||
+ | [[Category:T-cell leukemias]] |
Revision as of 12:13, 23 June 2024
Section editor | |
---|---|
Bhagirathbhai Dholaria, MBBS Vanderbilt University Nashville, TN, USA |
Are you looking for a regimen, but can't find it here? It is possible that we've moved it to the historical regimens page.
5 regimens on this page
5 variants on this page
|
- We have moved How I Treat articles to a dedicated 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.
NCCN
- NCCN does not currently have guidelines at this granular level; please see NCCN Guidelines - T-cell Lymphomas.
Untreated
CHOP-14
CHOP-14: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Predniso(lo)ne every 14 days
CHOP-DI: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Predniso(lo)ne, Dose-Intense
I-CHOP: Intensive Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Predniso(lo)ne
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy | Comparative Toxicity |
---|---|---|---|---|---|
Itoh et al. 2002 (JCOG 9505) | 1995-1998 | Randomized Phase 2 (E-de-esc) | dose-escalated CHOP | Did not meet primary endpoint of CR rate | Less toxic |
Tsukasaki et al. 2007 (JCOG 9801) | 1998-2003 | Phase 3 (C) | mLSG15 | Did not meet primary endpoint of OS | Less toxic |
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
Glucocorticoid therapy
- Prednisone (Sterapred) 100 mg PO once per day on days 1 to 5
Supportive therapy
- Filgrastim (Neupogen) given once ANC decreased to less than 1000/μL and continued once per day until count increased to greater than 5000/μL
14-day cycle for 8 cycles
CNS therapy
Intrathecal triple-therapy was given during recovery phase of cycles 1, 3, and 5 after platelet count was greater than 70 x 109/L.
- Cytarabine (Ara-C) 40 mg IT
- Methotrexate (MTX) 15 mg IT
- Prednisone (Sterapred) 10 mg IT
3 doses, total
References
- JCOG 9505: Itoh K, Ohtsu T, Fukuda H, Sasaki Y, Ogura M, Morishima Y, Chou T, Aikawa K, Uike N, Mizorogi F, Ohno T, Ikeda S, Sai T, Taniwaki M, Kawano F, Niimi M, Hotta T, Shimoyama M, Tobinai K; JCOG. Randomized phase II study of biweekly CHOP and dose-escalated CHOP with prophylactic use of lenograstim (glycosylated G-CSF) in aggressive non-Hodgkin's lymphoma: Japan Clinical Oncology Group Study 9505. Ann Oncol. 2002 Sep;13(9):1347-55. link to original article PubMed
- JCOG 9801: Tsukasaki K, Utsunomiya A, Fukuda H, Shibata T, Fukushima T, Takatsuka Y, Ikeda S, Masuda M, Nagoshi H, Ueda R, Tamura K, Sano M, Momita S, Yamaguchi K, Kawano F, Hanada S, Tobinai K, Shimoyama M, Hotta T, Tomonaga M; JCOG. VCAP-AMP-VECP compared with biweekly CHOP for adult T-cell leukemia-lymphoma: Japan Clinical Oncology Group Study JCOG9801. J Clin Oncol. 2007 Dec 1;25(34):5458-64. Epub 2007 Oct 29. link to original article contains dosing details in manuscript PubMed NCT00145002
mLSG15
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Tsukasaki et al. 2007 (JCOG 9801) | 1998-2003 | Phase 3 (E-esc) | CHOP-14 | Did not meet primary endpoint of OS |
Ishida et al. 2015 (Kyowa 0761-003) | 2010-2011 | Randomized Phase 2 (C) | mLSG15 & Mogamulizumab | Did not meet primary endpoint of CR rate |
Note: Ranimustine is not available in the United States and is approved only in Japan.
Chemotherapy
- Vincristine (Oncovin) 1 mg/m2 (maximum dose of 2 mg) IV once on day 1
- Cyclophosphamide (Cytoxan) 350 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 40 mg/m2 IV once on day 1, then 30 mg/m2 IV once on day 8
- Ranimustine (Cymerin) 60 mg/m2 IV once on day 8
- Vindesine (Eldisine) 2.4 mg/m2 IV once on day 15
- Etoposide (Vepesid) 100 mg/m2 IV once per day on days 15 to 17
- Carboplatin (Paraplatin) 250 mg/m2 IV once on day 15
Glucocorticoid therapy
- Prednisone (Sterapred) 40 mg/m2 PO once per day on days 1, 8, 15 to 17
28-day cycle for 6 cycles
CNS therapy, prophylaxis
- Cytarabine (Ara-C) 40 mg IT, admixed with MTX & prednisone
- Methotrexate (MTX) 15 mg IT, admixed with Ara-C & prednisone
- Prednisone (Sterapred) 10 mg IT, admixed with Ara-C & MTX
Given after cycles 1, 3, and 5 after platelets greater than 70 x 109/L and within 2 days before the next cycle
References
- JCOG 9801: Tsukasaki K, Utsunomiya A, Fukuda H, Shibata T, Fukushima T, Takatsuka Y, Ikeda S, Masuda M, Nagoshi H, Ueda R, Tamura K, Sano M, Momita S, Yamaguchi K, Kawano F, Hanada S, Tobinai K, Shimoyama M, Hotta T, Tomonaga M; JCOG. VCAP-AMP-VECP compared with biweekly CHOP for adult T-cell leukemia-lymphoma: Japan Clinical Oncology Group Study JCOG9801. J Clin Oncol. 2007 Dec 1;25(34):5458-64. Epub 2007 Oct 29. link to original article contains dosing details in manuscript PubMed NCT00145002
- Kyowa 0761-003: Ishida T, Jo T, Takemoto S, Suzushima H, Uozumi K, Yamamoto K, Uike N, Saburi Y, Nosaka K, Utsunomiya A, Tobinai K, Fujiwara H, Ishitsuka K, Yoshida S, Taira N, Moriuchi Y, Imada K, Miyamoto T, Akinaga S, Tomonaga M, Ueda R. Dose-intensified chemotherapy alone or in combination with mogamulizumab in newly diagnosed aggressive adult T-cell leukaemia-lymphoma: a randomized phase II study. Br J Haematol. 2015 Jun;169(5):672-82. Epub 2015 Mar 2. link to original article link to PMC article PubMed NCT01173887
Relapsed or refractory
Alemtuzumab monotherapy
Regimen
Study | Dates of enrollment | Evidence |
---|---|---|
Sharma et al. 2016 | 2004-2009 | Phase 2 |
Note: Scheduling is timed to start on a Monday.
Targeted therapy
- Alemtuzumab (Campath) as follows:
- Cycle 1: 3 mg IV once on day 1, then 10 mg IV once on day 2, then 30 mg IV once per day on days 3 & 5
- Cycles 2 to 12: 30 mg IV once per day on days 1, 3, 5 or 2, 4, 6 (three times per week)
Supportive therapy
- Antibacterial prophylaxis: Trimethoprim-Sulfamethoxazole (Bactrim DS) 160/80 mg PO three times per week
- Antiviral prophylaxis: Famciclovir (Famvir) or Valganciclovir (Valcyte) once per day
- Antifungal prophylaxis: Fluconazole (Diflucan)
7-day cycle for up to 12 cycles
References
- Sharma K, Janik JE, O'Mahony D, Stewart D, Pittaluga S, Stetler-Stevenson M, Jaffe ES, Raffeld M, Fleisher TA, Lee CC, Steinberg SM, Waldmann TA, Morris JC. Phase II study of alemtuzumab (CAMPATH-1) in patients with HTLV-1-associated adult T-cell leukemia/lymphoma. Clin Cancer Res. 2017 Jan 1;23(1):35-42. Epub 2016 Aug 2. link to original article link to PMC article contains dosing details in manuscript PubMed
Lenalidomide monotherapy
Regimen
Study | Dates of enrollment | Evidence | Efficacy |
---|---|---|---|
Ishida et al. 2016 (ATLL-002) | 2012-2014 | Phase 2 | ORR: 42% (95% CI 23-63) |
References
- ATLL-002: Ishida T, Fujiwara H, Nosaka K, Taira N, Abe Y, Imaizumi Y, Moriuchi Y, Jo T, Ishizawa K, Tobinai K, Tsukasaki K, Ito S, Yoshimitsu M, Otsuka M, Ogura M, Midorikawa S, Ruiz W, Ohtsu T. Multicenter phase II study of lenalidomide in relapsed or recurrent adult T-cell leukemia/lymphoma: ATLL-002. J Clin Oncol. 2016 Dec;34(34):4086-4093. Epub 2016 Sep 30. link to original article contains dosing details in manuscript PubMed NCT01724177
Valemetostat monotherapy
Regimen
Study | Dates of enrollment | Evidence |
---|---|---|
Izutsu et al. 2022 (DS3201-A-J201) | 2019-11 to 2020-10 | Phase 2 (RT) |
Targeted therapy
- Valemetostat (Ezharmia) 200 mg PO once per day on days 1 to 28, taken at least 2 hours before or at least 1 hour after a meal
28-day cycles
References
- DS3201-A-J201: Izutsu K, Makita S, Nosaka K, Yoshimitsu M, Utsunomiya A, Kusumoto S, Morishima S, Tsukasaki K, Kawamata T, Ono T, Rai S, Katsuya H, Ishikawa J, Yamada H, Kato K, Tachibana M, Kakurai Y, Adachi N, Tobinai K, Yonekura K, Ishitsuka K. An open-label, single-arm phase 2 trial of valemetostat for relapsed or refractory adult T-cell leukemia/lymphoma. Blood. 2023 Mar 9;141(10):1159-1168. Epub 2022 Sep 27. link to original article link to PMC article contains dosing details in manuscript PubMed NCT04102150