Difference between revisions of "Peripheral T-cell lymphoma - historical"

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m (Text replacement - "As a general rule, this includes the inferior arm(s) of a randomized study, unless said regimens continue to be recommended by trustworthy sources such as the [http://www.nccn.org/professionals/physician_gls/f_guidelines.asp NCCN Guidelines]. " to "")
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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. As a general rule, this includes the inferior arm(s) of a randomized study, unless said regimens continue to be recommended by trustworthy sources such as the [http://www.nccn.org/professionals/physician_gls/f_guidelines.asp NCCN Guidelines]. Is there a regimen missing from this list? See the [[Peripheral T-cell lymphoma|main PTCL page]] for current regimens.
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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. Is there a regimen missing from this list? See the [[Peripheral T-cell lymphoma|main PTCL page]] for current regimens.
 
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=Relapsed or Refractory=
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=Relapsed or refractory=
 
==Bortezomib & Panobinostat {{#subobject:bd8c5d|Regimen=1}}==
 
==Bortezomib & Panobinostat {{#subobject:bd8c5d|Regimen=1}}==
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===Regimen {{#subobject:cec60c|Variant=1}}===
 
===Regimen {{#subobject:cec60c|Variant=1}}===
 
{| 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
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!style="width: 25%"|Years of enrollment
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!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]]
 
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|[https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(15)00097-6/fulltext Tan et al. 2015 (SGH651)]
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|[https://doi.org/10.1016/S2352-3026(15)00097-6 Tan et al. 2015 (SGH651)]
 
|2009-2013
 
|2009-2013
 
| style="background-color:#91cf61" |Phase 2
 
| style="background-color:#91cf61" |Phase 2
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====Targeted therapy====
 
====Targeted therapy====
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*[[Bortezomib (Velcade)]] 1.3 mg/m<sup>2</sup> IV once per day on days 1, 4, 8, 11
 
*[[Bortezomib (Velcade)]] 1.3 mg/m<sup>2</sup> IV once per day on days 1, 4, 8, 11
 
*[[Panobinostat (Farydak)]] 20 mg PO once per day on days 1, 3, 5, 8, 10, 12
 
*[[Panobinostat (Farydak)]] 20 mg PO once per day on days 1, 3, 5, 8, 10, 12
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'''21-day cycle for up to 8 cycles'''
 
'''21-day cycle for up to 8 cycles'''
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</div></div>
 
===References===
 
===References===
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#Tan D, Phipps C, Hwang WY, Tan SY, Yeap CH, Chan YH, Tay K, Lim ST, Lee YS, Kumar SG, Ng SC, Fadilah S, Kim WS, Goh YT; SGH651 Investigators. Panobinostat in combination with bortezomib in patients with relapsed or refractory peripheral T-cell lymphoma: an open-label, multicentre phase 2 trial. Lancet Haematol. 2015 Aug;2(8):e326-33. Epub 2015 Jul 7. [https://doi.org/10.1016/S2352-3026(15)00097-6 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/26688485/ PubMed] [https://clinicaltrials.gov/study/NCT00901147 NCT00901147]
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#Tan D, Phipps C, Hwang WY, Tan SY, Yeap CH, Chan YH, Tay K, Lim ST, Lee YS, Kumar SG, Ng SC, Fadilah S, Kim WS, Goh YT; SGH651 Investigators. Panobinostat in combination with bortezomib in patients with relapsed or refractory peripheral T-cell lymphoma: an open-label, multicentre phase 2 trial. Lancet Haematol. 2015 Aug;2(8):e326-33. Epub 2015 Jul 7. [https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(15)00097-6/fulltext link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/26688485 PubMed] NCT00901147
 
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==Romidepsin monotherapy {{#subobject:510429|Regimen=1}}==
 
==Romidepsin monotherapy {{#subobject:510429|Regimen=1}}==
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===Regimen {{#subobject:fd7901|Variant=1}}===
 
===Regimen {{#subobject:fd7901|Variant=1}}===
 
{| 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
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!style="width: 20%"|Years of enrollment
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!style="width: 20%"|Dates of enrollment
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
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!style="width: 20%"|Comparator
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
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|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3112033/ Piekarz et al. 2011 (NIH 01-C-0049)]
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|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3112033/ Piekarz et al. 2011 (NIH 01-C-0049<sub>PTCL</sub>)]
 
|NR
 
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| style="background-color:#91cf61" |Phase 2
 
| style="background-color:#91cf61" |Phase 2
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| style="background-color:#4d4d4d; color:white" |ORR: Investigator assessment: 29% <br>Central review: 25%
 
| style="background-color:#4d4d4d; color:white" |ORR: Investigator assessment: 29% <br>Central review: 25%
 
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|[https://doi.org/10.1200/JCO.18.00899 O'Connor et al. 2019 (LUMIERE)]
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|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6494247/ O'Connor et al. 2019 (LUMIERE)]
 
|2012-2014
 
|2012-2014
 
| style="background-color:#1a9851" |Phase 3 (C)
 
| style="background-color:#1a9851" |Phase 3 (C)
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|[[#Alisertib_monotherapy_77|Alisertib]]
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|[[#Alisertib_monotherapy_999|Alisertib]]
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| style="background-color:#ffffbf" |Did not meet primary endpoints of ORR/PFS
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| style="background-color:#ffffbf" |Did not meet co-primary endpoints of ORR/PFS
 
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''Note: patients in NIH 01-C-0049 had a median of 3 prior treatments (range 1-11); patients in GPI-06-0002 had a median of 2 prior treatments (range 1-8).''
 
''Note: patients in NIH 01-C-0049 had a median of 3 prior treatments (range 1-11); patients in GPI-06-0002 had a median of 2 prior treatments (range 1-8).''
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<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
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*[[Romidepsin (Istodax)]] 14 mg/m<sup>2</sup> IV over 4 hours once per day on days 1, 8, 15
 
*[[Romidepsin (Istodax)]] 14 mg/m<sup>2</sup> IV over 4 hours once per day on days 1, 8, 15
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'''28-day cycle for up to 6 cycles, with optional extension of treatment for patients with stable disease or response'''
 
'''28-day cycle for up to 6 cycles, with optional extension of treatment for patients with stable disease or response'''
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</div></div>
 
===References===
 
===References===
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#'''NIH 01-C-0049<sub>PTCL</sub>:''' Piekarz RL, Frye R, Prince HM, Kirschbaum MH, Zain J, Allen SL, Jaffe ES, Ling A, Turner M, Peer CJ, Figg WD, Steinberg SM, Smith S, Joske D, Lewis I, Hutchins L, Craig M, Fojo AT, Wright JJ, Bates SE. Phase 2 trial of romidepsin in patients with peripheral T-cell lymphoma. Blood. 2011 Jun 2;117(22):5827-34. Epub 2011 Feb 25. [http://www.bloodjournal.org/content/117/22/5827 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3112033/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/21355097/ PubMed] [https://clinicaltrials.gov/study/NCT00007345 NCT00007345]
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#'''NIH 01-C-0049:''' Piekarz RL, Frye R, Prince HM, Kirschbaum MH, Zain J, Allen SL, Jaffe ES, Ling A, Turner M, Peer CJ, Figg WD, Steinberg SM, Smith S, Joske D, Lewis I, Hutchins L, Craig M, Fojo AT, Wright JJ, Bates SE. Phase 2 trial of romidepsin in patients with peripheral T-cell lymphoma. Blood. 2011 Jun 2;117(22):5827-34. Epub 2011 Feb 25. [http://www.bloodjournal.org/content/117/22/5827 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3112033/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/21355097 PubMed] NCT00007345
 
 
<!-- Presented in part at the 52nd Annual Meeting of the American Society of Hematology, Orlando, FL, December 4-7, 2010; at the 5th Biennial Workshop on the Clinical Translation of Epigenetics in Cancer Therapy, San Diego, CA, January 14-16, 2011; at the T-Cell Lymphoma Forum, San Francisco, CA, January 27-29, 2011; and at the 47th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, June 3-7, 2011. -->
 
<!-- Presented in part at the 52nd Annual Meeting of the American Society of Hematology, Orlando, FL, December 4-7, 2010; at the 5th Biennial Workshop on the Clinical Translation of Epigenetics in Cancer Therapy, San Diego, CA, January 14-16, 2011; at the T-Cell Lymphoma Forum, San Francisco, CA, January 27-29, 2011; and at the 47th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, June 3-7, 2011. -->
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#'''GPI-06-0002:''' Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Borchmann P, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan S, Shustov A, Nichols J, Carroll S, Balser J, Balser B, Horwitz S. Results from a pivotal, open-label, phase II study of romidepsin in relapsed or refractory peripheral T-cell lymphoma after prior systemic therapy. J Clin Oncol. 2012 Feb 20;30(6):631-6. Epub 2012 Jan 23. [https://doi.org/10.1200/jco.2011.37.4223 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/22271479 PubMed] NCT00426764
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#'''GPI-06-0002:''' Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Borchmann P, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan S, Shustov A, Nichols J, Carroll S, Balser J, Balser B, Horwitz S. Results from a pivotal, open-label, phase II study of romidepsin in relapsed or refractory peripheral T-cell lymphoma after prior systemic therapy. J Clin Oncol. 2012 Feb 20;30(6):631-6. Epub 2012 Jan 23. [https://doi.org/10.1200/jco.2011.37.4223 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/22271479/ PubMed] [https://clinicaltrials.gov/study/NCT00426764 NCT00426764]
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##'''Update:''' Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan Iyer S, Shustov A, Nielsen T, Nichols J, Wolfson J, Balser B, Horwitz S. Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses. J Hematol Oncol. 2014 Jan 23;7(1):11. [http://www.jhoonline.org/content/7/1/11 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4016573/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/24456586 PubMed]
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##'''Update:''' Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan Iyer S, Shustov A, Nielsen T, Nichols J, Wolfson J, Balser B, Horwitz S. Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses. J Hematol Oncol. 2014 Jan 23;7(1):11. [https://doi.org/10.1186/1756-8722-7-11 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4016573/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/24456586/ PubMed]
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##'''Update:''' Foss F, Horwitz S, Pro B, Prince HM, Sokol L, Balser B, Wolfson J, Coiffier B. Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial. J Hematol Oncol. 2016 Mar 10;9:22. [http://jhoonline.biomedcentral.com/articles/10.1186/s13045-016-0243-8 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4785666/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26965915 PubMed]
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##'''Update:''' Foss F, Horwitz S, Pro B, Prince HM, Sokol L, Balser B, Wolfson J, Coiffier B. Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial. J Hematol Oncol. 2016 Mar 10;9:22. [http://jhoonline.biomedcentral.com/articles/10.1186/s13045-016-0243-8 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4785666/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26965915/ PubMed]
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#'''LUMIERE:''' Connor OA, Özcan M, Jacobsen ED, Roncero JM, Trotman J, Demeter J, Masszi T, Pereira J, Ramchandren R, Beaven A, Caballero D, Horwitz SM, Lennard A, Turgut M, Hamerschlak N, d'Amore FA, Foss F, Kim WS, Leonard JP, Zinzani PL, Chiattone CS, Hsi ED, Trümper L, Liu H, Sheldon-Waniga E, Ullmann CD, Venkatakrishnan K, Leonard EJ, Shustov AR; Lumiere Study Investigators. Randomized phase III study of alisertib or investigator's choice (selected single agent) in patients with relapsed or refractory peripheral T-cell lymphoma. J Clin Oncol. 2019 Mar 10;37(8):613-623. Epub 2019 Feb 1. [https://doi.org/10.1200/JCO.18.00899 link to original article] '''contains protocol''' [https://pubmed.ncbi.nlm.nih.gov/30707661 PubMed] NCT01482962
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#'''LUMIERE:''' Connor OA, Özcan M, Jacobsen ED, Roncero JM, Trotman J, Demeter J, Masszi T, Pereira J, Ramchandren R, Beaven A, Caballero D, Horwitz SM, Lennard A, Turgut M, Hamerschlak N, d'Amore FA, Foss F, Kim WS, Leonard JP, Zinzani PL, Chiattone CS, Hsi ED, Trümper L, Liu H, Sheldon-Waniga E, Ullmann CD, Venkatakrishnan K, Leonard EJ, Shustov AR; Lumiere Study Investigators. Randomized phase III study of alisertib or investigator's choice (selected single agent) in patients with relapsed or refractory peripheral T-cell lymphoma. J Clin Oncol. 2019 Mar 10;37(8):613-623. Epub 2019 Feb 1. [https://doi.org/10.1200/JCO.18.00899 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6494247/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30707661/ PubMed] [https://clinicaltrials.gov/study/NCT01482962 NCT01482962]
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[[Category:Peripheral T-cell lymphoma regimens]]
 
[[Category:Peripheral T-cell lymphoma regimens]]
 
[[Category:Disease-specific pages]]
 
[[Category:Disease-specific pages]]
 
[[Category:T-cell lymphomas]]
 
[[Category:T-cell lymphomas]]
 
[[Category:Historical regimens]]
 
[[Category:Historical regimens]]

Revision as of 11:26, 13 May 2024

Back to Top

The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. Is there a regimen missing from this list? See the main PTCL page for current regimens.

2 regimens on this page
2 variants on this page


Relapsed or refractory

Bortezomib & Panobinostat

Regimen

Study Dates of enrollment Evidence Efficacy
Tan et al. 2015 (SGH651) 2009-2013 Phase 2 ORR: 43% (95% CI, 23-63)

Targeted therapy

21-day cycle for up to 8 cycles

References

  1. Tan D, Phipps C, Hwang WY, Tan SY, Yeap CH, Chan YH, Tay K, Lim ST, Lee YS, Kumar SG, Ng SC, Fadilah S, Kim WS, Goh YT; SGH651 Investigators. Panobinostat in combination with bortezomib in patients with relapsed or refractory peripheral T-cell lymphoma: an open-label, multicentre phase 2 trial. Lancet Haematol. 2015 Aug;2(8):e326-33. Epub 2015 Jul 7. link to original article contains dosing details in manuscript PubMed NCT00901147

Romidepsin monotherapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Piekarz et al. 2011 (NIH 01-C-0049PTCL) NR Phase 2 ORR: 38% (95% CI 24-53)
Coiffier et al. 2012 (GPI-06-0002) NR Phase 2 (RT) ORR: Investigator assessment: 29%
Central review: 25%
O'Connor et al. 2019 (LUMIERE) 2012-2014 Phase 3 (C) Alisertib Did not meet co-primary endpoints of ORR/PFS

Note: patients in NIH 01-C-0049 had a median of 3 prior treatments (range 1-11); patients in GPI-06-0002 had a median of 2 prior treatments (range 1-8).

Targeted therapy

28-day cycle for up to 6 cycles, with optional extension of treatment for patients with stable disease or response

References

  1. NIH 01-C-0049PTCL: Piekarz RL, Frye R, Prince HM, Kirschbaum MH, Zain J, Allen SL, Jaffe ES, Ling A, Turner M, Peer CJ, Figg WD, Steinberg SM, Smith S, Joske D, Lewis I, Hutchins L, Craig M, Fojo AT, Wright JJ, Bates SE. Phase 2 trial of romidepsin in patients with peripheral T-cell lymphoma. Blood. 2011 Jun 2;117(22):5827-34. Epub 2011 Feb 25. link to original article contains dosing details in manuscript link to PMC article PubMed NCT00007345
  2. GPI-06-0002: Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Borchmann P, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan S, Shustov A, Nichols J, Carroll S, Balser J, Balser B, Horwitz S. Results from a pivotal, open-label, phase II study of romidepsin in relapsed or refractory peripheral T-cell lymphoma after prior systemic therapy. J Clin Oncol. 2012 Feb 20;30(6):631-6. Epub 2012 Jan 23. link to original article contains dosing details in manuscript PubMed NCT00426764
    1. Update: Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan Iyer S, Shustov A, Nielsen T, Nichols J, Wolfson J, Balser B, Horwitz S. Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses. J Hematol Oncol. 2014 Jan 23;7(1):11. link to original article link to PMC article PubMed
    2. Update: Foss F, Horwitz S, Pro B, Prince HM, Sokol L, Balser B, Wolfson J, Coiffier B. Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial. J Hematol Oncol. 2016 Mar 10;9:22. link to original article link to PMC article PubMed
  3. LUMIERE: Connor OA, Özcan M, Jacobsen ED, Roncero JM, Trotman J, Demeter J, Masszi T, Pereira J, Ramchandren R, Beaven A, Caballero D, Horwitz SM, Lennard A, Turgut M, Hamerschlak N, d'Amore FA, Foss F, Kim WS, Leonard JP, Zinzani PL, Chiattone CS, Hsi ED, Trümper L, Liu H, Sheldon-Waniga E, Ullmann CD, Venkatakrishnan K, Leonard EJ, Shustov AR; Lumiere Study Investigators. Randomized phase III study of alisertib or investigator's choice (selected single agent) in patients with relapsed or refractory peripheral T-cell lymphoma. J Clin Oncol. 2019 Mar 10;37(8):613-623. Epub 2019 Feb 1. link to original article contains dosing details in manuscript link to PMC article PubMed NCT01482962
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