Difference between revisions of "Adult T-cell leukemia-lymphoma"

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'''Use of this site is subject to you reading and agreeing with the terms set forth in the [[HemOnc.org_-_A_Hematology_Oncology_Wiki:General_disclaimer|disclaimer]].'''
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<span id="BackToTop"></span>
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<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">
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Is there a regimen missing from this list?  Would you like to share a different dosage/schedule or an additional reference for a regimen? Have you noticed an error?  Do you have an idea that will help the site grow to better meet your needs and the needs of many others?  You are [[How_to_contribute|invited to contribute to the site]].
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[[#top|Back to Top]]
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</div>
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{{#lst:Editorial board transclusions|tcl}}
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''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;"
 
|-
 
|-
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|<div style="background-color: #66FF66; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Regimen |limit=10000|format=sum}} regimens on this page</b></font></div>
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|<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>
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<div style="background-color: #66CCFF; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Variant |limit=10000|format=sum}} variants on this page</b></font></div>
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<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>
 
|}
 
|}
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*''We have moved [[How I Treat]] articles to a dedicated page.''
 
{{TOC limit|limit=3}}
 
{{TOC limit|limit=3}}
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=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 [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}}==
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{| class="wikitable" style="float:right; margin-left: 5px;"
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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]]
 
|-
 
|-
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|[[#toc|back to top]]
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|[https://doi.org/10.1093/annonc/mdf287 Itoh et al. 2002 (JCOG 9505)]
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|}
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|1995-1998
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CHOP: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''rednisone
+
|style="background-color:#1a9851"|Randomized Phase 2 (E-de-esc)
−
 
+
|[[#Dose-escalated_CHOP_999|dose-escalated CHOP]]
−
Synonyms: CHOP-DI, I-CHOP
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| style="background-color:#ffffbf" |Did not meet primary endpoint of CR rate
−
 
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| style="background-color:#1a9850" |Less toxic
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Structured Concept: none
 
−
 
 
−
===Regimen {{#subobject:ad2f7b|Variant=1}}===
 
−
{| border="1" style="text-align:center;" !align="left"
 
−
|'''Study'''
 
−
|[[Levels_of_Evidence#Evidence|'''Evidence''']]
 
−
|'''Comparator'''
 
 
|-
 
|-
−
|[http://jco.ascopubs.org/content/25/34/5458.long Tsukasaki et al. 2007 (JCOG 9801)]
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|[https://doi.org/10.1200/jco.2007.11.9958 Tsukasaki et al. 2007 (JCOG 9801)]
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|<span
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|1998-2003
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style="background:#00CD00;
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|style="background-color:#1a9851"|Phase 3 (C)
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padding:3px 6px 3px 6px;
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|[[#mLSG15|mLSG15]]
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border-color:black;
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|style="background-color:#ffffbf"|Did not meet primary endpoint of OS
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border-width:2px;
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| style="background-color:#1a9850" |Less toxic
−
border-style:solid;">Phase III</span>
 
−
|[[Adult_T-cell_leukemia-lymphoma#mLSG15|mLSG15]]
 
 
|-
 
|-
 
|}
 
|}
−
 
+
<div class="toccolours" style="background-color:#b3e2cd">
−
*[[Cyclophosphamide (Cytoxan)]] 750 mg/m2 IV once on day 1
+
====Chemotherapy====
−
*[[Doxorubicin (Adriamycin)]] 50 mg/m2 IV once on day 1
+
*[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1
−
*[[Vincristine (Oncovin)]] 1.4 mg/m2 (max dose 2 mg) 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> (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 medications:
+
*[[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 neutrophil count decreased to less than 1 × 10^9/L and continued once per day until count increased to greater than 5 x 10^9/L
+
'''14-day cycle for 8 cycles'''
−
 
+
====CNS therapy====
−
'''14-day cycle x 8 cycles'''
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''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.''
−
 
+
*[[Cytarabine (Ara-C)]] 40 mg IT  
−
====Intrathecal component====
 
−
''Intrathecal triple-therapy was given during recovery phase of cycles 1, 3, and 5 after platelet count was > 70k.''
 
−
*[[Cytarabine (Cytosar)]] 40 mg IT  
 
 
*[[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; Japan Clinical Oncology Group Study JCOG9801. 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. [http://jco.ascopubs.org/content/25/34/5458.long link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/17968021 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; [[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}}==
−
{| class="wikitable" style="float:right; margin-left: 5px;"
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<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:1dc050|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/10.1200/jco.2007.11.9958 Tsukasaki et al. 2007 (JCOG 9801)]
 +
|1998-2003
 +
|style="background-color:#1a9851"|Phase 3 (E-esc)
 +
|[[#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 (Kyowa 0761-003)]
 +
|2010-2011
 +
|style="background-color:#1a9851"|Randomized Phase 2 (C)
 +
|[[#mLSG15_.26_Mogamulizumab_999|mLSG15 & Mogamulizumab]]
 +
|style="background-color:#ffffbf"|Did not meet primary endpoint of CR rate
 
|-
 
|-
−
|[[#toc|back to top]]
 
 
|}
 
|}
 +
''Note: Ranimustine is not available in the United States and is approved only in Japan.''
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Chemotherapy====
 +
*[[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
 +
*[[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
 +
*[[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
 +
*[[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'''
 +
====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 10<sup>9</sup>/L and within 2 days before the next cycle'''
 +
</div></div>
 +
===References===
 +
<!-- Presented in part at the 47th Annual Meeting of the American Society of Hematology, December 10-13, 2005, Atlanta, GA. -->
 +
#'''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]
 +
#'''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]
  
−
===Regimen {{#subobject:1dc050|Variant=1}}===
+
=Relapsed or refractory=
−
{| border="1" style="text-align:center;" !align="left"  
+
==Alemtuzumab monotherapy {{#subobject:efc45a|Regimen=1}}==
−
|'''Study'''
+
<div class="toccolours" style="background-color:#eeeeee">
−
|[[Levels_of_Evidence#Evidence|'''Evidence''']]
+
===Regimen {{#subobject:32e392|Variant=1}}===
−
|'''Comparator'''
+
{| 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]]
 
|-
 
|-
−
|[http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2141.2001.02737.x/full Yamada et al. 2001 (JCOG 9303)]
+
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5215752/ Sharma et al. 2016]
−
|<span
+
|2004-2009
−
style="background:#eeee00;
+
|style="background-color:#91cf61"|Phase 2
−
padding:3px 6px 3px 6px;
 
−
border-color:black;
 
−
border-width:2px;
 
−
border-style:solid;">Phase II</span>
 
−
|
 
 
|-
 
|-
−
!colspan="4" align="center"|
+
|}
 +
''Note: Scheduling is timed to start on a Monday.''
 +
<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===
 +
<!-- 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 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}}==
 +
<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]]
 
|-
 
|-
−
|[http://jco.ascopubs.org/content/25/34/5458.long Tsukasaki et al. 2007 (JCOG 9801)]
+
|[https://doi.org/10.1200/JCO.2016.67.7732 Ishida et al. 2016 (ATLL-002)]
−
|<span
+
|2012-2014
−
style="background:#00CD00;
+
|style="background-color:#91cf61"|Phase 2
−
padding:3px 6px 3px 6px;
+
|ORR: 42% (95% CI 23-63)
−
border-color:black;
 
−
border-width:2px;
 
−
border-style:solid;">Phase III</span>
 
−
|[[Adult_T-cell_leukemia-lymphoma#CHOP-14|CHOP-14]]
 
 
|-
 
|-
−
!colspan="4" align="center"|
+
|}
 +
<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]
 +
 
 +
==Valemetostat monotherapy {{#subobject:bval0e|Regimen=1}}==
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:6val44|Variant=1}}===
 +
{| 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]]
 
|-
 
|-
−
|[http://onlinelibrary.wiley.com/doi/10.1111/bjh.13338/full Ishida et al. 2015]
+
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc10651775/ Izutsu et al. 2022 (DS3201-A-J201)]
−
|<span
+
|2019-11 to 2020-10
−
style="background:#00CD00;
+
| style="background-color:#91cf61" |Phase 2 (RT)
−
padding:3px 6px 3px 6px;
 
−
border-color:black;
 
−
border-width:2px;
 
−
border-style:solid;">Randomized Phase II</span>
 
−
|[[Mogamulizumab_(KW-0761)#Adult_T-cell_leukemia-lymphoma|mLSG15 & mogamulizumab]]
 
 
|-
 
|-
 
|}
 
|}
−
To be completed
+
<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===
 +
#'''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]
  
−
===References===
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[[Category:Adult T-cell leukemia-lymphoma regimens]]
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# Yamada Y, Tomonaga M, Fukuda H, Hanada S, Utsunomiya A, Tara M, Sano M, Ikeda S, Takatsuki K, Kozuru M, Araki K, Kawano F, Niimi M, Tobinai K, Hotta T, Shimoyama M. A new G-CSF-supported combination chemotherapy, LSG15, for adult T-cell leukaemia-lymphoma: Japan Clinical Oncology Group Study 9303. Br J Haematol. 2001 May;113(2):375-82. [http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2141.2001.02737.x/full link to original article] [PubMed http://www.ncbi.nlm.nih.gov/pubmed/11380402]
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# 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; Japan Clinical Oncology Group Study JCOG9801. 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. [http://jco.ascopubs.org/content/25/34/5458.long link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/17968021 PubMed]
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# 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. [http://onlinelibrary.wiley.com/doi/10.1111/bjh.13338/full link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/25733162 PubMed]
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[[Category:T-cell leukemias]]

Revision as of 12:13, 23 June 2024

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Section editor
Bdholaria.jpg
 Bhagirathbhai Dholaria, MBBS
Vanderbilt University
Nashville, TN, USA
LinkedIn

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

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

Glucocorticoid therapy

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.

3 doses, total

References

  1. 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
  2. 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

Glucocorticoid therapy

28-day cycle for 6 cycles

CNS therapy, prophylaxis

Given after cycles 1, 3, and 5 after platelets greater than 70 x 109/L and within 2 days before the next cycle

References

  1. 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
  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. 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

7-day cycle for up to 12 cycles

References

  1. 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)

Targeted therapy

Continued indefinitely

References

  1. 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

  1. 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
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