Difference between revisions of "Anaplastic large cell 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}}
 +
'''Note: these studies were specific to ALCL or had ALCL subgroups; regimens used in [[Peripheral_T-cell_lymphoma|PTCL, NOS]] are also often used in this condition. Certain regimens have been moved to dedicated pages:
 +
*'''[[Anaplastic large cell lymphoma, pediatric|Pediatric ALCL]]
 +
</big>
 
{| 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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{{TOC limit|limit=3}}
 +
=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.esmo.org/ ESMO]==
 +
*'''2015:''' d'Amore et al. [https://doi.org/10.1093/annonc/mdv201 Peripheral T-cell lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up] [https://pubmed.ncbi.nlm.nih.gov/26314772/ PubMed]
 +
==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=
−
 
+
==BV-CHP {{#subobject:6964de|Regimen=1}}==
−
==DA-EPOCH {{#subobject:6c5911|Regimen=1}}==
+
BV-CHP: '''<u>B</u>'''rentuximab '''<u>V</u>'''edotin, '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>P</u>'''rednisone
−
{| class="wikitable" style="float:right; margin-left: 5px;"
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<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:985a91|Variant=1}}===
 +
{| class="wikitable" style="color:white; background-color:#404040"
 +
|<small>'''FDA-recommended dose'''</small>
 
|-
 
|-
−
|[[#top|back to top]]
 
 
|}
 
|}
−
DA-EPOCH: '''<u>D</u>'''ose '''<u>A</u>'''djusted '''<u>E</u>'''toposide, '''<u>P</u>'''rednisone, '''<u>O</u>'''ncovin (Vincristine), '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin)
+
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
−
 
+
!style="width: 20%"|Study
−
===Regimen {{#subobject:659929|Variant=1}}===
+
!style="width: 20%"|Dates of enrollment
−
{| border="1" style="text-align:center;" !align="left"  
+
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
−
|'''Study'''
+
!style="width: 20%"|Comparator
−
|[[Levels_of_Evidence#Evidence|'''Evidence''']]
+
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4697904/ Dunleavy et al. 2016]
+
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6436818/ Horwitz et al. 2018 (ECHELON-2)]
−
|style="background-color:#eeee00"|Phase II
+
|2013-2016
 +
|style="background-color:#1a9851"|Phase 3 (E-RT-switch-ooc)
 +
|[[#CHOP|CHOP]]
 +
| style="background-color:#1a9850" |Superior PFS (primary endpoint)<br>Median PFS: 48.2 vs 20.8 mo<br>(HR 0.71, 95% CI 0.54-0.93)<br><br>Superior OS (secondary endpoint)<br>Median OS: NYR vs NYR<br>(HR 0.66, 95% CI 0.46-0.95)
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Antibody-drug conjugate therapy====
 +
*[[Brentuximab vedotin (Adcetris)]] 1.8 mg/kg (maximum dose of 180 mg) IV once on day 1
 
====Chemotherapy====
 
====Chemotherapy====
−
*[[Etoposide (Vepesid)]] 50 mg/m<sup>2</sup>/day IV continuous infusion over 96 hours on days 1 to 4 (total dose per cycle: 200 mg/m<sup>2</sup>)
+
*[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1
−
*[[Prednisone (Sterapred)]] 60 mg/m<sup>2</sup> PO BID on days 1 to 5
+
*[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1
−
*[[Vincristine (Oncovin)]] 0.4 mg/m<sup>2</sup>/day IV continuous infusion over 96 hours on days 1 to 4 (total dose per cycle: 1.6 mg/m2; dose was not capped)
+
====Glucocorticoid therapy====
−
*[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV over 2 hours once on day 5
+
*[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5
−
*[[Doxorubicin (Adriamycin)]] 10 mg/m<sup>2</sup>/day IV continuous infusion over 96 hours on days 1 to 4 (total dose per cycle: 40 mg/m<sup>2</sup>)
 
−
 
 
−
====Supportive medications====
 
−
*[[Filgrastim (Neupogen)]] 300 mcg SQ once per day, starting on day 6 and continuing until ANC greater than 5000/uL past nadir
 
−
*[[Trimethoprim/Sulfamethoxazole (Bactrim DS)]] 160/800 mg (or equivalent if allergic) PO once per day on 3 days per week
 
−
**Note: It's assumed this is what the supplement for Dunleavy et al. 2013 meant by "Baxtrim (sulphametoxazole and trimethoprim)"
 
−
*[[Omeprazole (Prilosec)]] 20 mg (or equivalent) PO once per day
 
−
*[[Docusate (Colace)]] (dose not specified) and [[Sennosides (Senna)]] 2 tablets PO BID as needed for constipation
 
−
*Lactulose 20 g PO Q6H as needed for constipation
 
−
*Hepatitis B surface antigen positive patients received daily antiviral therapy until 8 weeks after completion of chemotherapy
 
−
 
 
 
'''21-day cycle for 6 to 8 cycles'''
 
'''21-day cycle for 6 to 8 cycles'''
−
 
+
</div></div>
−
====Dose adjustments====
 
−
*Start cycle 1 as described above.
 
−
*Obtain CBCs twice per week for nadir measurements.
 
−
*If nadir ANC greater than 500/uL, increase etoposide, doxorubicin, and cyclophosphamide by one level (20%) compared to previous cycle.
 
−
*If nadir ANC less than 500/uL, use same doses as last cycle.
 
−
*If nadir platelet count less than 25 x 10<sup>9</sup>/L, decrease etoposide, doxorubicin, and cyclophosphamide by 20% compared to the previous cycle.
 
−
 
 
 
===References===
 
===References===
−
# Dunleavy K, Pittaluga S, Shovlin M, Roschewski M, Lai C, Steinberg SM, Jaffe ES, Wilson WH. Phase II trial of dose-adjusted EPOCH in untreated systemic anaplastic large cell lymphoma. Haematologica. 2016 Jan;101(1):e27-9. [http://www.haematologica.org/content/101/1/e27.long link to original article] '''refers to protocol in [http://www.nejm.org/doi/full/10.1056/NEJMoa1214561 Dunleavy et al. 2013]''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4697904/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/26518748 PubMed]
+
# '''ECHELON-2:''' Horwitz S, O'Connor OA, Pro B, Illidge T, Fanale M, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Lennard A, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Iyer S, Zinzani PL, Hua Z, Little M, Rao S, Woolery J, Manley T, Trümper L; ECHELON-2 Study Group. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2019 Jan 19;393(10168):229-240. Epub 2018 Dec 4. Erratum in: Lancet. 2019 Jan 19;393(10168):228. [https://doi.org/10.1016/S0140-6736(18)32984-2 link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6436818/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30522922/ PubMed] [https://clinicaltrials.gov/study/NCT01777152 NCT01777152]
−
 
+
==CHOEP-14 {{#subobject:c516ab|Regimen=1}}==
−
==CHOEP {{#subobject:c516ab|Regimen=1}}==
+
CHOEP-14: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>E</u>'''toposide, '''<u>P</u>'''rednisone every '''<u>14</u>''' days
−
{| class="wikitable" style="float:right; margin-left: 5px;"
+
<br>CHOPE
 +
<br>VACOP
 +
===Example orders===
 +
*[[Example orders for CHOEP in lymphoma]]
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:f61648|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]]
 
|-
 
|-
−
|[[#top|back to top]]
+
|[https://doi.org/10.1182/blood-2003-06-2094 Pfreundschuh et al. 2004 (NHL-B1)]
 +
|1993-2000
 +
| style="background-color:#91cf61" |Phase 3, fewer than 20 pts in this subgroup (E-esc)
 +
|1. [[#CHOEP-21|CHOEP-21]]<br>2. [[#CHOP|CHOP-21]]<br> 3. [[#CHOP-14_999|CHOP-14]]
 +
| style="background-color:#d3d3d3" |Not reported by subgroup
 +
| style="background-color:#d3d3d3" |Not reported by subgroup
 
|}
 
|}
−
CHOEP: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>E</u>'''toposide, '''<u>P</u>'''rednisone
+
''Note: This regimen was used in 16 patients with ALCL in the NHL-B1 trial. The authors did not report a subgroup analysis for this minority population.''
−
 
+
<div class="toccolours" style="background-color:#b3e2cd">
−
Synonyms: CHOPE, VACOP
+
====Chemotherapy====
−
 
+
*[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1
−
Structured Concept: [http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary==NCI%20Thesaurus&version==12.09d&code==C9702&key==1863263010&b==1&n==null C9702] (NCI-T), [http://ncim.nci.nih.gov/ncimbrowser/ConceptReport.jsp?dictionary==NCI%20MetaThesaurus&code==C0212922 C0212922](NCI-MT/UMLS)
+
*[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1
−
 
+
*[[Vincristine (Oncovin)]] 2 mg IV once on day 1
 +
*[[Etoposide (Vepesid)]] 100 mg/m<sup>2</sup> IV once per day on days 1 to 3
 +
====Glucocorticoid therapy====
 +
*[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5
 +
====Supportive therapy====
 +
*[[Filgrastim (Neupogen)]] by the following weight-based criteria:
 +
**Less than 75 kg: 300 mcg SC once per day on days 4 to 13
 +
**75 kg or more: 480 mcg SC once per day on days 4 to 13
 +
'''14-day cycle for 6 cycles'''; next cycle to start as long as WBC count is greater than 2.5 x 10<sup>9</sup>/L and platelets greater than 80 x 10<sup>9</sup>/L
 +
</div>
 +
<div class="toccolours" style="background-color:#cbd5e7">
 +
====Subsequent treatment====
 +
*NHL-B1, patients with initial bulky disease (mass conglomerate at least 7.5 cm): [[#Radiation_therapy_888|RT]] consolidation x 3600 cGy to extranodal sites of disease when possible
 +
</div></div>
 +
===References===
 +
# '''NHL-B1:''' Pfreundschuh M, Trümper L, Kloess M, Schmits R, Feller AC, Rudolph C, Reiser M, Hossfeld DK, Metzner B, Hasenclever D, Schmitz N, Glass B, Rübe C, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of young patients with good-prognosis (normal LDH) aggressive lymphomas: results of the NHL-B1 trial of the DSHNHL. Blood. 2004 Aug 1;104(3):626-33. Epub 2004 Feb 24. [https://doi.org/10.1182/blood-2003-06-2094 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/14982884/ PubMed]
 +
==CHOEP-21 {{#subobject:c621ab|Regimen=1}}==
 +
CHOEP-21: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>E</u>'''toposide, '''<u>P</u>'''rednisone every '''<u>21</u>''' days
 +
<br>CHOPE
 +
<br>VACOP
 
===Example orders===
 
===Example orders===
 
*[[Example orders for CHOEP in lymphoma]]
 
*[[Example orders for CHOEP in lymphoma]]
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
−
===Regimen {{#subobject:f61648|Variant=1}}===
+
===Regimen {{#subobject:fan248|Variant=1}}===
−
{| border="1" style="text-align:center;" !align="left"  
+
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
−
|'''Study'''
+
!style="width: 17%"|Study
−
|[[Levels_of_Evidence#Evidence|'''Evidence''']]
+
!style="width: 15%"|Dates of enrollment
−
|'''Comparator'''
+
!style="width: 17%"|[[Levels_of_Evidence#Evidence|Evidence]]
−
|[[Levels_of_Evidence#Efficacy|'''Efficacy''']]
+
!style="width: 17%"|Comparator
−
|[[Levels_of_Evidence#Toxicity|'''Toxicity''']]
+
!style="width: 17%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
!style="width: 17%"|[[Levels_of_Evidence#Toxicity|Comparative Toxicity]]
 
|-
 
|-
−
|[http://www.bloodjournal.org/content/104/3/626.long Pfreundschuh et al. 2004 (NHL-B1)]
+
|[https://doi.org/10.1182/blood-2003-06-2094 Pfreundschuh et al. 2004 (NHL-B1)]
−
|style="background-color:#00cd00"|Phase III
+
|1993-2000
−
|CHOP-21<br> CHOP-14
+
| style="background-color:#91cf61" |Phase 3, fewer than 20 pts in this subgroup (E-esc)
−
|Not reported by subgroup
+
|1. [[#CHOEP-14|CHOEP-14]]<br>2. [[#CHOP|CHOP-21]]<br>3. [[#CHOP-14_999|CHOP-14]]
−
|Not reported by subgroup
+
| style="background-color:#d3d3d3" |Not reported by subgroup
 +
| style="background-color:#d3d3d3" |Not reported by subgroup
 
|}
 
|}
−
 
+
''Note: This regimen was used in 20 patients with ALCL in the NHL-B1 trial. The authors did not report a subgroup analysis for this minority population.''
−
''This regimen was used in 20 ALCL patients (CHOEP-21) and 16 ALCL patients (CHOEP-14) in the NHL-B1 trial. The authors did not report a subgroup analysis for this minority population.''
+
<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)]] 2 mg IV once on day 1
 
*[[Vincristine (Oncovin)]] 2 mg IV once on day 1
 +
*[[Etoposide (Vepesid)]] 100 mg/m<sup>2</sup> IV once per day on days 1 to 3
 +
====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
−
*[[Etoposide (Vepesid)]] 100 mg/m<sup>2</sup> IV once per day on days 1 to 3
+
====Supportive therapy====
−
*Patients with initial bulky disease (mass conglomerate at least 7.5 cm) received 36 Gy radiation therapy and to extranodal sites of disease when possible
+
*[[Filgrastim (Neupogen)]] is by discretion of ordering physician
−
 
+
'''21-day cycle for 6 cycles'''; next cycle to start as long as WBC count is greater than 2.5 x 10<sup>9</sup>/L and platelets greater than 80 x 10<sup>9</sup>/L
−
====Supportive medications====
+
</div>
−
*For 14-day cycles: [[Filgrastim (Neupogen)]] 300 mcg (for patients less than 75 kg) or 480 mcg (for patients at least 75 kg) SC once per day on days 4 to 13
+
<div class="toccolours" style="background-color:#cbd5e7">
−
*[[Filgrastim (Neupogen)]] use for 21-day cycles is by discretion of ordering physician
+
====Subsequent treatment====
−
 
+
*NHL-B1, patients with initial bulky disease (mass conglomerate at least 7.5 cm): [[#Radiation_therapy_888|RT]] consolidation x 3600 cGy to extranodal sites of disease when possible
−
'''14 or 21-day cycles for 6 cycles''', next cycle to start as long as WBC count is greater than 2.5 x 10<sup>9</sup>/L and platelets greater than 80 x 10<sup>9</sup>/L
+
</div></div>
−
*CHOEP-14 uses 14-day cycles; CHOEP-21 uses 21-day cycles
 
−
 
 
 
===References===
 
===References===
−
# Pfreundschuh M, Trümper L, Kloess M, Schmits R, Feller AC, Rudolph C, Reiser M, Hossfeld DK, Metzner B, Hasenclever D, Schmitz N, Glass B, Rübe C, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of young patients with good-prognosis (normal LDH) aggressive lymphomas: results of the NHL-B1 trial of the DSHNHL. Blood. 2004 Aug 1;104(3):626-33. Epub 2004 Feb 24. [http://bloodjournal.hematologylibrary.org/content/104/3/626.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/14982884 PubMed]
+
# '''NHL-B1:''' Pfreundschuh M, Trümper L, Kloess M, Schmits R, Feller AC, Rudolph C, Reiser M, Hossfeld DK, Metzner B, Hasenclever D, Schmitz N, Glass B, Rübe C, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of young patients with good-prognosis (normal LDH) aggressive lymphomas: results of the NHL-B1 trial of the DSHNHL. Blood. 2004 Aug 1;104(3):626-33. Epub 2004 Feb 24. [https://doi.org/10.1182/blood-2003-06-2094 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/14982884/ PubMed]
−
 
 
 
==CHOP {{#subobject:4ca454|Regimen=1}}==
 
==CHOP {{#subobject:4ca454|Regimen=1}}==
−
{| class="wikitable" style="float:right; margin-left: 5px;"
+
CHOP: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''rednisone
 +
<br>CHOP-21
 +
<br>ACOP
 +
<br>CAVP
 +
<br>COPA
 +
<br>VACP
 +
<br>VCAP
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen variant #1, capped vincristine {{#subobject:9e662b|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://www.ncbi.nlm.nih.gov/pmc/articles/PMC6436818/ Horwitz et al. 2018 (ECHELON-2)]
 +
|2013-2016
 +
|style="background-color:#1a9851"|Phase 3 (C)
 +
|[[#BV-CHP|BV-CHP]]
 +
| style="background-color:#d73027" |Inferior OS
 
|-
 
|-
−
|[[#top|back to top]]
 
 
|}
 
|}
−
CHOP: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''rednisone
+
<div class="toccolours" style="background-color:#b3e2cd">
−
 
+
====Chemotherapy====
−
Synonyms: CHOP-21, ACOP, CAVP, COPA, VACP, VCAP
+
*[[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
−
Structured Concept: [http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary==NCI%20Thesaurus&version==12.09d&code==C9549&key==1801231401&b==1&n==null C9549] (NCI-T), [http://ncim.nci.nih.gov/ncimbrowser/ConceptReport.jsp?dictionary==NCI%20MetaThesaurus&code==C0055598 C0055598] (NCI-MT/UMLS)
+
*[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1
−
 
+
====Glucocorticoid therapy====
−
===Regimen {{#subobject:9e770b|Variant=1}}===
+
*[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5
−
{| border="1" style="text-align:center;" !align="left"  
+
'''21-day cycle for 6 to 8 cycles'''
−
|'''Study'''
+
</div></div><br>
−
|[[Levels_of_Evidence#Evidence|'''Evidence''']]
+
<div class="toccolours" style="background-color:#eeeeee">
−
|'''Comparator'''
+
===Regimen variant #2, flat-dose vincristine {{#subobject:9e770b|Variant=1}}===
−
|[[Levels_of_Evidence#Efficacy|'''Efficacy''']]
+
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
−
|[[Levels_of_Evidence#Toxicity|'''Toxicity''']]
+
!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]]
 
|-
 
|-
−
|[http://www.bloodjournal.org/content/104/3/626.long Pfreundschuh et al. 2004 (NHL-B1)]
+
|[https://doi.org/10.1182/blood-2003-06-2094 Pfreundschuh et al. 2004 (NHL-B1)]
−
|style="background-color:#eeee00"|Phase III, <20 pts in arm
+
|1993-2000
−
|CHOEP<br> CHOP-14
+
| style="background-color:#91cf61" |Phase 3, fewer than 20 pts in this subgroup (C)
−
|Not reported by subgroup
+
|1. [[#CHOEP-14|CHOEP-14]]<br>2. [[#CHOEP-21|CHOEP-21]]<br>3. [[#CHOP-14_999|CHOP-14]]
−
|Not reported by subgroup
+
| style="background-color:#d3d3d3" |Not reported by subgroup
 +
| style="background-color:#d3d3d3" |Not reported by subgroup
 
|}
 
|}
−
 
+
''Note: This regimen was used in 14 patients with ALCL in NHL-B1. The authors did not report a subgroup analysis for this minority population.''
−
''This regimen was used in 14 ALCL patients in the NHL-B1 trial. The authors did not report a subgroup analysis for this minority population.''
+
<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)]] 2 mg IV once on day 1
 
*[[Vincristine (Oncovin)]] 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====
+
*At the discretion of ordering physician: [[Filgrastim (Neupogen)]] by the following weight-based criteria:
−
*At the discretion of ordering physician: [[Filgrastim (Neupogen)]] 300 mcg (for patients less than 75 kg) or 480 mcg (for patients at least 75 kg) SC once per day on days 4 to 13  
+
**Less than 75 kg: 300 mcg SC once per day on days 4 to 13
−
 
+
**75 kg or more: 480 mcg SC once per day on days 4 to 13  
 
'''21-day cycle for 6 cycles'''
 
'''21-day cycle for 6 cycles'''
−
 
+
</div></div>
 +
===References===
 +
# '''NHL-B1:''' Pfreundschuh M, Trümper L, Kloess M, Schmits R, Feller AC, Rudolph C, Reiser M, Hossfeld DK, Metzner B, Hasenclever D, Schmitz N, Glass B, Rübe C, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of young patients with good-prognosis (normal LDH) aggressive lymphomas: results of the NHL-B1 trial of the DSHNHL. Blood. 2004 Aug 1;104(3):626-33. Epub 2004 Feb 24. [https://doi.org/10.1182/blood-2003-06-2094 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/14982884/ PubMed]
 +
# '''ECHELON-2:''' Horwitz S, O'Connor OA, Pro B, Illidge T, Fanale M, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Lennard A, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Iyer S, Zinzani PL, Hua Z, Little M, Rao S, Woolery J, Manley T, Trümper L; ECHELON-2 Study Group. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2019 Jan 19;393(10168):229-240. Epub 2018 Dec 4. Erratum in: Lancet. 2019 Jan 19;393(10168):228. [https://doi.org/10.1016/S0140-6736(18)32984-2 link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6436818/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30522922/ PubMed] [https://clinicaltrials.gov/study/NCT01777152 NCT01777152]
 +
==DA-EPOCH {{#subobject:6c5911|Regimen=1}}==
 +
DA-EPOCH: '''<u>D</u>'''ose '''<u>A</u>'''djusted '''<u>E</u>'''toposide, '''<u>P</u>'''rednisone, '''<u>O</u>'''ncovin (Vincristine), '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin)
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:659929|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]]
 +
|-
 +
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4697904/ Dunleavy et al. 2015 (NCI 93-C-0133<sub>ALCL</sub>)]
 +
|1993-2009
 +
|style="background-color:#91cf61"|Phase 2
 +
|-
 +
|}
 +
''Note: this should be considered a substudy under the master protocol NCI 93-C-0133.''
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Chemotherapy====
 +
*[[Etoposide (Vepesid)]] 50 mg/m<sup>2</sup>/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 200 mg/m<sup>2</sup>)
 +
*[[Vincristine (Oncovin)]] 0.4 mg/m<sup>2</sup>/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 1.6 mg/m<sup>2</sup>)
 +
*[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV over 2 hours once on day 5
 +
*[[Doxorubicin (Adriamycin)]] 10 mg/m<sup>2</sup>/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 40 mg/m<sup>2</sup>)
 +
====Glucocorticoid therapy====
 +
*[[Prednisone (Sterapred)]] 60 mg/m<sup>2</sup> PO twice per day on days 1 to 5
 +
====Supportive therapy====
 +
*[[Filgrastim (Neupogen)]] 300 mcg SC once per day, starting on day 6 and continuing until ANC greater than 5000/μL past nadir
 +
*[[Trimethoprim-Sulfamethoxazole (Bactrim DS)]] 160/800 mg (or equivalent if allergic) PO once per day on 3 days per week
 +
*[[Omeprazole (Prilosec)]] 20 mg (or equivalent) PO once per day
 +
*[[Docusate (Colace)]] (dose not specified) and [[Sennosides (Senna)]] 2 tablets PO twice per day as needed for constipation
 +
*Lactulose 20 g PO every 6 hours as needed for constipation
 +
*Hepatitis B surface antigen positive patients: received daily [[:Category:Antivirals|antiviral]] therapy until 8 weeks after completion of chemotherapy
 +
'''21-day cycle for 6 to 8 cycles'''
 +
</div>
 +
<div class="toccolours" style="background-color:#fff2ae">
 +
====Dose and schedule modifications====
 +
*Start cycle 1 as described above.
 +
*Obtain CBCs twice per week for nadir measurements.
 +
*If nadir ANC greater than 500/μL, increase etoposide, doxorubicin, and cyclophosphamide by one level (20%) compared to previous cycle.
 +
*If nadir ANC less than 500/μL, use same doses as last cycle.
 +
*If nadir platelet count less than 25 x 10<sup>9</sup>/L, decrease etoposide, doxorubicin, and cyclophosphamide by 20% compared to the previous cycle.
 +
</div></div>
 
===References===
 
===References===
−
# Pfreundschuh M, Trümper L, Kloess M, Schmits R, Feller AC, Rudolph C, Reiser M, Hossfeld DK, Metzner B, Hasenclever D, Schmitz N, Glass B, Rübe C, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of young patients with good-prognosis (normal LDH) aggressive lymphomas: results of the NHL-B1 trial of the DSHNHL. Blood. 2004 Aug 1;104(3):626-33. Epub 2004 Feb 24. [http://bloodjournal.hematologylibrary.org/content/104/3/626.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/14982884 PubMed]
+
# '''NCI 93-C-0133<sub>ALCL</sub>:''' Dunleavy K, Pittaluga S, Shovlin M, Roschewski M, Lai C, Steinberg SM, Jaffe ES, Wilson WH. Phase II trial of dose-adjusted EPOCH in untreated systemic anaplastic large cell lymphoma. Haematologica. 2016 Jan;101(1):e27-9. Epub 2015 Oct 30. [https://doi.org/10.3324/haematol.2015.131151 link to original article] '''refers to protocol in [https://doi.org/10.1056/NEJMoa1214561 Dunleavy et al. 2013]''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4697904/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26518748/ PubMed] [https://clinicaltrials.gov/study/NCT00001337 NCT00001337]
−
 
 
−
=Relapsed/refractory=
 
  
 +
=Relapsed or refractory, salvage therapy=
 
==Brentuximab vedotin monotherapy {{#subobject:e32d67|Regimen=1}}==
 
==Brentuximab vedotin monotherapy {{#subobject:e32d67|Regimen=1}}==
−
{| class="wikitable" style="float:right; margin-left: 5px;"
+
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen variant #1, 16 cycles {{#subobject:46fbc9|Variant=1}}===
 +
{| class="wikitable" 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://doi.org/10.1200/jco.2011.38.0402 Pro et al. 2012 (SG035-0004)]
 +
|2009-2010
 +
|style="background-color:#91cf61"|Phase 2 (RT)
 
|-
 
|-
−
|[[#top|back to top]]
 
 
|}
 
|}
−
 
+
<div class="toccolours" style="background-color:#b3e2cd">
−
===Regimen {{#subobject:46fbc9|Variant=1}}===
+
====Antibody-drug conjugate therapy====
−
{| border="1" style="text-align:center;" !align="left"  
+
*[[Brentuximab vedotin (Adcetris)]] 1.8 mg/kg IV over 30 minutes once on day 1
−
|'''Study'''
+
'''21-day cycle for up to 16 infusions'''
−
|[[Levels_of_Evidence#Evidence|'''Evidence''']]
+
</div></div><br>
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen variant #2, bridge to transplant {{#subobject:48bjc9|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]]
 +
|-
 +
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3659993/ Gibb et al. 2012]
 +
|2010-12 to 2011-08
 +
|style="background-color:#91cf61"|Named Patient Programme
 
|-
 
|-
−
|[http://jco.ascopubs.org/content/30/18/2190.long Pro et al. 2012 (SG035-0004)]
+
|}
−
|style="background-color:#eeee00"|Phase II
+
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Antibody-drug conjugate therapy====
 +
*[[Brentuximab vedotin (Adcetris)]] 1.8 mg/kg IV over 30 minutes once on day 1
 +
'''21-day cycles until transplant'''
 +
</div></div><br>
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen variant #3, indefinite {{#subobject:46nz3b|Variant=1}}===
 +
{| class="wikitable" 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/PMC3994656/ Bartlett et al. 2014]
+
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3731651/ Gopal et al. 2012 (SGN35-006)]
−
|style="background-color:#ff0000"|Phase II, <20 pts in subgroup
+
|2009-NR
 +
|style="background-color:#ffffbe"|Phase 2, fewer than 20 pts in subgroup
 
|-
 
|-
 
|}
 
|}
−
''Note: '''Bartlett et al. 2014''' is a re-treatment trial; all patients were previously exposed to brentuximab vedotin. Patients who had received the 1.2 mg/kg dose on a prior trial also received that dose at re-treatment.''
+
''Note: SGN35-006 is a re-treatment trial; all patients were previously exposed to brentuximab vedotin. Patients who had received the 1.2 mg/kg dose on a prior trial also received that dose at re-treatment.''
−
====Chemotherapy====
+
<div class="toccolours" style="background-color:#b3e2cd">
−
*[[Brentuximab vedotin (Adcetris)]] 1.8 mg/kg IV over 30 minutes on day 1
+
====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 infusions (SG035-0004) or until progression (Bartlett et al. 2014)'''
+
'''21-day cycles'''
−
 
+
</div></div>
 
===References===
 
===References===
−
# Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Yang Y, Sievers EL, Kennedy DA, Shustov A. Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study. J Clin Oncol. 2012 Jun 20;30(18):2190-6. Epub 2012 May 21. [http://jco.ascopubs.org/content/30/18/2190.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/22614995 PubMed]
+
# '''SGN35-006:''' Gopal AK, Ramchandren R, O'Connor OA, Berryman RB, Advani RH, Chen R, Smith SE, Cooper M, Rothe A, Matous JV, Grove LE, Zain J. Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplantation. Blood. 2012 Jul 19;120(3):560-8. Epub 2012 Apr 17. [https://doi.org/10.1182/blood-2011-12-397893 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3731651/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/22510871/ PubMed] [https://clinicaltrials.gov/study/NCT00947856 NCT00947856]
−
## '''Update: Abstract:''' Barbara Pro, MD, Ranjana Advani, MD, Pauline Brice, MD, Nancy L. Bartlett, MD, Joseph D. Rosenblatt, MD, Tim Illidge, Jeffrey Matous, MD, Radhakrishnan Ramchandern, MD, Michelle A. Fanale, MD, Joseph M. Connors, MD, Yinghui Wang, MS, Dirk Huebner, MD, Dana A. Kennedy, PharmD, BCOP and Andrei R. Shustov, MD. Four-Year Survival Data from an Ongoing Pivotal Phase 2 Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma. ASH Annual Meeting 2014, Abstract 3095 [https://ash.confex.com/ash/2014/webprogram/Paper67039.html link to abstract]
+
## '''Update:''' Bartlett NL, Chen R, Fanale MA, Brice P, Gopal A, Smith SE, Advani R, Matous JV, Ramchandren R, Rosenblatt JD, Huebner D, Levine P, Grove L, Forero-Torres A. Retreatment with brentuximab vedotin in patients with CD30-positive hematologic malignancies. J Hematol Oncol. 2014 Mar 19;7:24. [https://doi.org/10.1186/1756-8722-7-24 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3994656/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/24642247/ PubMed]
−
# Gibb A, Jones C, Bloor A, Kulkarni S, Illidge T, Linton K, Radford J. Brentuximab vedotin in refractory CD30+ lymphomas: a bridge to allogeneic transplantation in approximately one quarter of patients treated on a Named Patient Programme at a single UK center. Haematologica. 2013 Apr;98(4):611-4. Epub 2012 Oct 12. [http://www.haematologica.org/content/98/4/611.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3659993/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/23065511 PubMed]
+
# '''SG035-0004:''' Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Yang Y, Sievers EL, Kennedy DA, Shustov A. Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study. J Clin Oncol. 2012 Jun 20;30(18):2190-6. Epub 2012 May 21. [https://doi.org/10.1200/jco.2011.38.0402 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/22614995/ PubMed] [https://clinicaltrials.gov/study/NCT00866047 NCT00866047]
−
# '''Retrospective:''' Gopal AK, Bartlett NL, Forero-Torres A, Younes A, Chen R, Friedberg JW, Matous JV, Shustov AR, Smith SE, Zain J, O'Meara MM, Fanale MA. Brentuximab vedotin in patients aged 60 years or older with relapsed or refractory CD30-positive lymphomas: a retrospective evaluation of safety and efficacy. Leuk Lymphoma. 2014 Oct;55(10):2328-34. Epub 2014 Feb 24. [http://www.tandfonline.com/doi/full/10.3109/10428194.2013.876496 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/24359243 PubMed]
+
<!-- ## '''Update: Abstract:''' Barbara Pro, MD, Ranjana Advani, MD, Pauline Brice, MD, Nancy L. Bartlett, MD, Joseph D. Rosenblatt, MD, Tim Illidge, Jeffrey Matous, MD, Radhakrishnan Ramchandern, MD, Michelle A. Fanale, MD, Joseph M. Connors, MD, Yinghui Wang, MS, Dirk Huebner, MD, Dana A. Kennedy, PharmD, BCOP and Andrei R. Shustov, MD. Four-Year Survival Data from an Ongoing Pivotal Phase 2 Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma. ASH Annual Meeting 2014, Abstract 3095 -->
−
# Bartlett NL, Chen R, Fanale MA, Brice P, Gopal A, Smith SE, Advani R, Matous JV, Ramchandren R, Rosenblatt JD, Huebner D, Levine P, Grove L, Forero-Torres A. Retreatment with brentuximab vedotin in patients with CD30-positive hematologic malignancies. J Hematol Oncol. 2014 Mar 19;7:24. [http://jhoonline.biomedcentral.com/articles/10.1186/1756-8722-7-24 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3994656/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/24642247 PubMed]
+
## '''Update:''' Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Fenton K, Huebner D, Pinelli JM, Kennedy DA, Shustov A. Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma. Blood. 2017 Dec 21;130(25):2709-2717. Epub 2017 Oct 3. [https://doi.org/10.1182/blood-2017-05-780049 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5746164/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28974506/ PubMed]
 +
# Gibb A, Jones C, Bloor A, Kulkarni S, Illidge T, Linton K, Radford J. Brentuximab vedotin in refractory CD30+ lymphomas: a bridge to allogeneic transplantation in approximately one quarter of patients treated on a Named Patient Programme at a single UK center. Haematologica. 2013 Apr;98(4):611-4. Epub 2012 Oct 12. [https://doi.org/10.3324/haematol.2012.069393 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3659993/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/23065511/ PubMed]
 +
# '''Retrospective:''' Gopal AK, Bartlett NL, Forero-Torres A, Younes A, Chen R, Friedberg JW, Matous JV, Shustov AR, Smith SE, Zain J, O'Meara MM, Fanale MA. Brentuximab vedotin in patients aged 60 years or older with relapsed or refractory CD30-positive lymphomas: a retrospective evaluation of safety and efficacy. Leuk Lymphoma. 2014 Oct;55(10):2328-34. Epub 2014 Feb 24. [https://doi.org/10.3109/10428194.2013.876496 link to original article] [https://pubmed.ncbi.nlm.nih.gov/24359243/ PubMed]
  
 
==DHAP {{#subobject:5a2988|Regimen=1}}==
 
==DHAP {{#subobject:5a2988|Regimen=1}}==
−
{| class="wikitable" style="float:right; margin-left: 5px;"
 
−
|-
 
−
|[[#top|back to top]]
 
−
|}
 
 
DHAP: '''<u>D</u>'''examethasone, '''<u>H</u>'''igh-dose '''<u>A</u>'''ra-C (cytarabine), '''<u>P</u>'''latinol (cisplatin)
 
DHAP: '''<u>D</u>'''examethasone, '''<u>H</u>'''igh-dose '''<u>A</u>'''ra-C (cytarabine), '''<u>P</u>'''latinol (cisplatin)
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:d2a377|Variant=1}}===
 
===Regimen {{#subobject:d2a377|Variant=1}}===
−
{| border="1" style="text-align:center;" !align="left"  
+
{| 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#Efficacy|'''Efficacy''']]
+
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
−
|[http://jco.ascopubs.org/content/32/31/3490.full Crump et al. 2014 (NCIC-CTG LY.12)]
+
|[https://doi.org/10.1200/jco.2013.53.9593 Crump et al. 2014 (NCIC-CTG LY.12)]
−
|style="background-color:#eeee00"|Phase III, <20 in this arm
+
|2003-2011
 +
|style="background-color:#91cf61"|Phase 3, <20 in this arm (C)
 
|[[Anaplastic_large_cell_lymphoma#GDP|GDP]]
 
|[[Anaplastic_large_cell_lymphoma#GDP|GDP]]
−
|style="background-color:#eeee00"|Non-inferior ORR
+
|style="background-color:#eeee01"|Non-inferior ORR
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
 +
*[[Cytarabine (Ara-C)]] 2000 mg/m<sup>2</sup> IV over 3 hours every 12 hours on day 2 (total dose per cycle: 4000 mg/m<sup>2</sup>)
 +
*[[Cisplatin (Platinol)]] 100 mg/m<sup>2</sup> IV continuous infusion over 24 hours, started on day 1
 +
====Glucocorticoid therapy====
 
*[[Dexamethasone (Decadron)]] 40 mg PO once per day on days 1 to 4
 
*[[Dexamethasone (Decadron)]] 40 mg PO once per day on days 1 to 4
−
*[[Cytarabine (Cytosar)]] 2000 mg/m<sup>2</sup> IV over 3 hours Q12H for 2 doses on day 2 (total of 2 doses)
 
−
*[[Cisplatin (Platinol)]] 100 mg/m<sup>2</sup> IV continuous infusion over 24 hours on day 1
 
−
 
 
'''21-day cycle for up to 3 cycles'''
 
'''21-day cycle for up to 3 cycles'''
−
 
+
</div></div>
 
===References===
 
===References===
 
<!-- Presented in part at the Annual Meeting of the American Society of Hematology, Atlanta, GA, December 7-10, 2013, and the International Conference on Malignant Lymphoma, Lugano, Switzerland, June 19-22, 2013. -->
 
<!-- Presented in part at the Annual Meeting of the American Society of Hematology, Atlanta, GA, December 7-10, 2013, and the International Conference on Malignant Lymphoma, Lugano, Switzerland, June 19-22, 2013. -->
−
# Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized Comparison of Gemcitabine, Dexamethasone, and Cisplatin Versus Dexamethasone, Cytarabine, and Cisplatin Chemotherapy Before Autologous Stem-Cell Transplantation for Relapsed and Refractory Aggressive Lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. Epub 2014 Sep 29. [http://jco.ascopubs.org/content/32/31/3490.full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/25267740 PubMed]
+
# '''NCIC-CTG LY.12:''' Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. Epub 2014 Sep 29. [https://doi.org/10.1200/jco.2013.53.9593 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/25267740/ PubMed] [https://clinicaltrials.gov/study/NCT00078949 NCT00078949]
−
 
 
 
==GDP {{#subobject:21f926|Regimen=1}}==
 
==GDP {{#subobject:21f926|Regimen=1}}==
−
{| class="wikitable" style="float:right; margin-left: 5px;"
+
GDP: '''<u>G</u>'''emcitabine, '''<u>D</u>'''examethasone, '''<u>P</u>'''latinol (Cisplatin)
−
|-
+
<div class="toccolours" style="background-color:#eeeeee">
−
|[[#top|back to top]]
 
−
|}
 
−
GDP: '''<u>G</u>'''emcitabine, '''<u>D</u>'''examethasone, '''<u>P</u>'''latinol
 
−
 
 
 
===Regimen {{#subobject:ce43d5|Variant=1}}===
 
===Regimen {{#subobject:ce43d5|Variant=1}}===
−
{| border="1" style="text-align:center;" !align="left"  
+
{| 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#Efficacy|'''Efficacy''']]
+
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
−
|[http://jco.ascopubs.org/content/32/31/3490.full Crump et al. 2014 (NCIC-CTG LY.12)]
+
|[https://doi.org/10.1200/jco.2013.53.9593 Crump et al. 2014 (NCIC-CTG LY.12)]
−
|style="background-color:#eeee00"|Phase III, <20 pts in this arm
+
|2003-2011
−
|[[Anaplastic_large_cell_lymphoma#DHAP|DHAP]]
+
|style="background-color:#91cf61"|Phase 3, fewer than 20 pts in this arm (E-switch-ic)
−
|style="background-color:#eeee00"|Non-inferior ORR
+
|[[#DHAP|DHAP]]
 +
|style="background-color:#eeee01"|Non-inferior ORR (co-primary endpoint)
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
 
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1 & 8
 
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1 & 8
 +
*[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV once on day 1
 +
====Glucocorticoid therapy====
 
*[[Dexamethasone (Decadron)]] 40 mg PO once per day on days 1 to 4
 
*[[Dexamethasone (Decadron)]] 40 mg PO once per day on days 1 to 4
−
*[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV once on day 1
 
−
 
 
'''21-day cycle for up to 3 cycles'''
 
'''21-day cycle for up to 3 cycles'''
−
 
+
</div></div>
 
===References===
 
===References===
 
<!-- Presented in part at the Annual Meeting of the American Society of Hematology, Atlanta, GA, December 7-10, 2013, and the International Conference on Malignant Lymphoma, Lugano, Switzerland, June 19-22, 2013. -->
 
<!-- Presented in part at the Annual Meeting of the American Society of Hematology, Atlanta, GA, December 7-10, 2013, and the International Conference on Malignant Lymphoma, Lugano, Switzerland, June 19-22, 2013. -->
−
# Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized Comparison of Gemcitabine, Dexamethasone, and Cisplatin Versus Dexamethasone, Cytarabine, and Cisplatin Chemotherapy Before Autologous Stem-Cell Transplantation for Relapsed and Refractory Aggressive Lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. Epub 2014 Sep 29. [http://jco.ascopubs.org/content/32/31/3490.full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/25267740 PubMed]
+
# '''NCIC-CTG LY.12:''' Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. Epub 2014 Sep 29. [https://doi.org/10.1200/jco.2013.53.9593 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/25267740/ PubMed] [https://clinicaltrials.gov/study/NCT00078949 NCT00078949]
−
 
+
=Consolidation after salvage therapy=
 +
==Fludarabine, Busulfan, Cyclophosphamide, then allo HSCT {{#subobject:84acb0|Regimen=1}}==
 +
FluBuCy: '''<u>Flu</u>'''darabine, '''<u>Bu</u>'''sulfan, '''<u>Cy</u>'''clophosphamide
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen variant #1, oral {{#subobject:bfe434|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]]
 +
|-
 +
|[https://doi.org/10.1016/S1470-2045(14)70161-5 Glass et al. 2014 (DSHNHL R3)]
 +
|2004-06-16 to 2009-03-24
 +
| style="background-color:#91cf61" |Phase 2
 +
|-
 +
|}
 +
{{#lst:Allogeneic HSCT|bfe434}}
 +
</div></div><br>
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen variant #2, intravenous {{#subobject:bfe434|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]]
 +
|-
 +
|[https://doi.org/10.1016/S1470-2045(14)70161-5 Glass et al. 2014 (DSHNHL R3)]
 +
|2004-06-16 to 2009-03-24
 +
| style="background-color:#91cf61" |Phase 2
 +
|-
 +
|}
 +
{{#lst:Allogeneic HSCT|bfe435}}
 +
</div></div>
 +
===References===
 +
<!-- # Glass B, rabbits Kamp J, Wulf G, Dreger P, Pfreundschuh M, Gramatzki M Silling G, Wilhelm C, Zeis M, Görlitz A, Pfeiffer S, Hilgers R, Truemper L, Schmitz N. High-dose chemotherapy Followed by allogeneic stem cell transplantation in relapsed and refractory high-risk aggressive non-Hodgkin's lymphoma: Results of a prospective study of the German high-grade non-Hodgkin's lymphoma study group. J Clin Oncol 30, 2012 (suppl; abstr 8004) -->
 +
# '''DSHNHL R3:''' Glass B, Hasenkamp J, Wulf G, Dreger P, Pfreundschuh M, Gramatzki M, Silling G, Wilhelm C, Zeis M, Görlitz A, Pfeiffer S, Hilgers R, Truemper L, Schmitz N; German High-Grade Lymphoma Study Group. Rituximab after lymphoma-directed conditioning and allogeneic stem-cell transplantation for relapsed and refractory aggressive non-Hodgkin lymphoma (DSHNHL R3): an open-label, randomised, phase 2 trial. Lancet Oncol. 2014 Jun;15(7):757-66. Epub 2014 May 11. [https://doi.org/10.1016/S1470-2045(14)70161-5 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/24827808/ PubMed] [https://clinicaltrials.gov/study/NCT00785330 NCT00785330]
 
[[Category:Anaplastic large cell lymphoma regimens]]
 
[[Category:Anaplastic large cell lymphoma regimens]]
 
[[Category:Disease-specific pages]]
 
[[Category:Disease-specific pages]]
−
[[Category:Disease index]]
+
[[Category:T-cell lymphomas]]

Latest revision as of 12:17, 3 July 2024

Back to Top

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

Note: these studies were specific to ALCL or had ALCL subgroups; regimens used in PTCL, NOS are also often used in this condition. Certain regimens have been moved to dedicated pages:

9 regimens on this page
12 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

NCCN

Untreated

BV-CHP

BV-CHP: Brentuximab Vedotin, Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Prednisone

Regimen

FDA-recommended dose
Study Dates of enrollment Evidence Comparator Comparative Efficacy
Horwitz et al. 2018 (ECHELON-2) 2013-2016 Phase 3 (E-RT-switch-ooc) CHOP Superior PFS (primary endpoint)
Median PFS: 48.2 vs 20.8 mo
(HR 0.71, 95% CI 0.54-0.93)

Superior OS (secondary endpoint)
Median OS: NYR vs NYR
(HR 0.66, 95% CI 0.46-0.95)

Antibody-drug conjugate therapy

Chemotherapy

Glucocorticoid therapy

21-day cycle for 6 to 8 cycles

References

  1. ECHELON-2: Horwitz S, O'Connor OA, Pro B, Illidge T, Fanale M, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Lennard A, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Iyer S, Zinzani PL, Hua Z, Little M, Rao S, Woolery J, Manley T, Trümper L; ECHELON-2 Study Group. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2019 Jan 19;393(10168):229-240. Epub 2018 Dec 4. Erratum in: Lancet. 2019 Jan 19;393(10168):228. link to original article contains dosing details in abstract link to PMC article PubMed NCT01777152

CHOEP-14

CHOEP-14: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Etoposide, Prednisone every 14 days
CHOPE
VACOP

Example orders

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy Comparative Toxicity
Pfreundschuh et al. 2004 (NHL-B1) 1993-2000 Phase 3, fewer than 20 pts in this subgroup (E-esc) 1. CHOEP-21
2. CHOP-21
3. CHOP-14 		Not reported by subgroup Not reported by subgroup

Note: This regimen was used in 16 patients with ALCL in the NHL-B1 trial. The authors did not report a subgroup analysis for this minority population.

Chemotherapy

Glucocorticoid therapy

Supportive therapy

  • Filgrastim (Neupogen) by the following weight-based criteria:
    • Less than 75 kg: 300 mcg SC once per day on days 4 to 13
    • 75 kg or more: 480 mcg SC once per day on days 4 to 13

14-day cycle for 6 cycles; next cycle to start as long as WBC count is greater than 2.5 x 109/L and platelets greater than 80 x 109/L

Subsequent treatment

  • NHL-B1, patients with initial bulky disease (mass conglomerate at least 7.5 cm): RT consolidation x 3600 cGy to extranodal sites of disease when possible

References

  1. NHL-B1: Pfreundschuh M, Trümper L, Kloess M, Schmits R, Feller AC, Rudolph C, Reiser M, Hossfeld DK, Metzner B, Hasenclever D, Schmitz N, Glass B, Rübe C, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of young patients with good-prognosis (normal LDH) aggressive lymphomas: results of the NHL-B1 trial of the DSHNHL. Blood. 2004 Aug 1;104(3):626-33. Epub 2004 Feb 24. link to original article contains dosing details in manuscript PubMed

CHOEP-21

CHOEP-21: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Etoposide, Prednisone every 21 days
CHOPE
VACOP

Example orders

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy Comparative Toxicity
Pfreundschuh et al. 2004 (NHL-B1) 1993-2000 Phase 3, fewer than 20 pts in this subgroup (E-esc) 1. CHOEP-14
2. CHOP-21
3. CHOP-14 		Not reported by subgroup Not reported by subgroup

Note: This regimen was used in 20 patients with ALCL in the NHL-B1 trial. The authors did not report a subgroup analysis for this minority population.

Chemotherapy

Glucocorticoid therapy

Supportive therapy

21-day cycle for 6 cycles; next cycle to start as long as WBC count is greater than 2.5 x 109/L and platelets greater than 80 x 109/L

Subsequent treatment

  • NHL-B1, patients with initial bulky disease (mass conglomerate at least 7.5 cm): RT consolidation x 3600 cGy to extranodal sites of disease when possible

References

  1. NHL-B1: Pfreundschuh M, Trümper L, Kloess M, Schmits R, Feller AC, Rudolph C, Reiser M, Hossfeld DK, Metzner B, Hasenclever D, Schmitz N, Glass B, Rübe C, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of young patients with good-prognosis (normal LDH) aggressive lymphomas: results of the NHL-B1 trial of the DSHNHL. Blood. 2004 Aug 1;104(3):626-33. Epub 2004 Feb 24. link to original article contains dosing details in manuscript PubMed

CHOP

CHOP: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisone
CHOP-21
ACOP
CAVP
COPA
VACP
VCAP

Regimen variant #1, capped vincristine

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Horwitz et al. 2018 (ECHELON-2) 2013-2016 Phase 3 (C) BV-CHP Inferior OS

Chemotherapy

Glucocorticoid therapy

21-day cycle for 6 to 8 cycles


Regimen variant #2, flat-dose vincristine

Study Dates of enrollment Evidence Comparator Comparative Efficacy Comparative Toxicity
Pfreundschuh et al. 2004 (NHL-B1) 1993-2000 Phase 3, fewer than 20 pts in this subgroup (C) 1. CHOEP-14
2. CHOEP-21
3. CHOP-14 		Not reported by subgroup Not reported by subgroup

Note: This regimen was used in 14 patients with ALCL in NHL-B1. The authors did not report a subgroup analysis for this minority population.

Chemotherapy

Glucocorticoid therapy

Supportive therapy

  • At the discretion of ordering physician: Filgrastim (Neupogen) by the following weight-based criteria:
    • Less than 75 kg: 300 mcg SC once per day on days 4 to 13
    • 75 kg or more: 480 mcg SC once per day on days 4 to 13

21-day cycle for 6 cycles

References

  1. NHL-B1: Pfreundschuh M, Trümper L, Kloess M, Schmits R, Feller AC, Rudolph C, Reiser M, Hossfeld DK, Metzner B, Hasenclever D, Schmitz N, Glass B, Rübe C, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of young patients with good-prognosis (normal LDH) aggressive lymphomas: results of the NHL-B1 trial of the DSHNHL. Blood. 2004 Aug 1;104(3):626-33. Epub 2004 Feb 24. link to original article contains dosing details in manuscript PubMed
  2. ECHELON-2: Horwitz S, O'Connor OA, Pro B, Illidge T, Fanale M, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Lennard A, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Iyer S, Zinzani PL, Hua Z, Little M, Rao S, Woolery J, Manley T, Trümper L; ECHELON-2 Study Group. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2019 Jan 19;393(10168):229-240. Epub 2018 Dec 4. Erratum in: Lancet. 2019 Jan 19;393(10168):228. link to original article contains dosing details in abstract link to PMC article PubMed NCT01777152

DA-EPOCH

DA-EPOCH: Dose Adjusted Etoposide, Prednisone, Oncovin (Vincristine), Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin)

Regimen

Study Dates of enrollment Evidence
Dunleavy et al. 2015 (NCI 93-C-0133ALCL) 1993-2009 Phase 2

Note: this should be considered a substudy under the master protocol NCI 93-C-0133.

Chemotherapy

Glucocorticoid therapy

Supportive therapy

21-day cycle for 6 to 8 cycles

Dose and schedule modifications

  • Start cycle 1 as described above.
  • Obtain CBCs twice per week for nadir measurements.
  • If nadir ANC greater than 500/μL, increase etoposide, doxorubicin, and cyclophosphamide by one level (20%) compared to previous cycle.
  • If nadir ANC less than 500/μL, use same doses as last cycle.
  • If nadir platelet count less than 25 x 109/L, decrease etoposide, doxorubicin, and cyclophosphamide by 20% compared to the previous cycle.

References

  1. NCI 93-C-0133ALCL: Dunleavy K, Pittaluga S, Shovlin M, Roschewski M, Lai C, Steinberg SM, Jaffe ES, Wilson WH. Phase II trial of dose-adjusted EPOCH in untreated systemic anaplastic large cell lymphoma. Haematologica. 2016 Jan;101(1):e27-9. Epub 2015 Oct 30. link to original article refers to protocol in Dunleavy et al. 2013 link to PMC article PubMed NCT00001337

Relapsed or refractory, salvage therapy

Brentuximab vedotin monotherapy

Regimen variant #1, 16 cycles

Study Dates of enrollment Evidence
Pro et al. 2012 (SG035-0004) 2009-2010 Phase 2 (RT)

Antibody-drug conjugate therapy

21-day cycle for up to 16 infusions


Regimen variant #2, bridge to transplant

Study Dates of enrollment Evidence
Gibb et al. 2012 2010-12 to 2011-08 Named Patient Programme

Antibody-drug conjugate therapy

21-day cycles until transplant


Regimen variant #3, indefinite

Study Dates of enrollment Evidence
Gopal et al. 2012 (SGN35-006) 2009-NR Phase 2, fewer than 20 pts in subgroup

Note: SGN35-006 is a re-treatment trial; all patients were previously exposed to brentuximab vedotin. Patients who had received the 1.2 mg/kg dose on a prior trial also received that dose at re-treatment.

Antibody-drug conjugate therapy

21-day cycles

References

  1. SGN35-006: Gopal AK, Ramchandren R, O'Connor OA, Berryman RB, Advani RH, Chen R, Smith SE, Cooper M, Rothe A, Matous JV, Grove LE, Zain J. Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplantation. Blood. 2012 Jul 19;120(3):560-8. Epub 2012 Apr 17. link to original article contains dosing details in manuscript link to PMC article PubMed NCT00947856
    1. Update: Bartlett NL, Chen R, Fanale MA, Brice P, Gopal A, Smith SE, Advani R, Matous JV, Ramchandren R, Rosenblatt JD, Huebner D, Levine P, Grove L, Forero-Torres A. Retreatment with brentuximab vedotin in patients with CD30-positive hematologic malignancies. J Hematol Oncol. 2014 Mar 19;7:24. link to original article contains dosing details in manuscript link to PMC article PubMed
  2. SG035-0004: Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Yang Y, Sievers EL, Kennedy DA, Shustov A. Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study. J Clin Oncol. 2012 Jun 20;30(18):2190-6. Epub 2012 May 21. link to original article contains dosing details in manuscript PubMed NCT00866047
    1. Update: Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Fenton K, Huebner D, Pinelli JM, Kennedy DA, Shustov A. Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma. Blood. 2017 Dec 21;130(25):2709-2717. Epub 2017 Oct 3. link to original article link to PMC article PubMed
  3. Gibb A, Jones C, Bloor A, Kulkarni S, Illidge T, Linton K, Radford J. Brentuximab vedotin in refractory CD30+ lymphomas: a bridge to allogeneic transplantation in approximately one quarter of patients treated on a Named Patient Programme at a single UK center. Haematologica. 2013 Apr;98(4):611-4. Epub 2012 Oct 12. link to original article contains dosing details in manuscript link to PMC article PubMed
  4. Retrospective: Gopal AK, Bartlett NL, Forero-Torres A, Younes A, Chen R, Friedberg JW, Matous JV, Shustov AR, Smith SE, Zain J, O'Meara MM, Fanale MA. Brentuximab vedotin in patients aged 60 years or older with relapsed or refractory CD30-positive lymphomas: a retrospective evaluation of safety and efficacy. Leuk Lymphoma. 2014 Oct;55(10):2328-34. Epub 2014 Feb 24. link to original article PubMed

DHAP

DHAP: Dexamethasone, High-dose Ara-C (cytarabine), Platinol (cisplatin)

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Crump et al. 2014 (NCIC-CTG LY.12) 2003-2011 Phase 3, <20 in this arm (C) GDP Non-inferior ORR

Chemotherapy

  • Cytarabine (Ara-C) 2000 mg/m2 IV over 3 hours every 12 hours on day 2 (total dose per cycle: 4000 mg/m2)
  • Cisplatin (Platinol) 100 mg/m2 IV continuous infusion over 24 hours, started on day 1

Glucocorticoid therapy

21-day cycle for up to 3 cycles

References

  1. NCIC-CTG LY.12: Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. Epub 2014 Sep 29. link to original article contains dosing details in manuscript PubMed NCT00078949

GDP

GDP: Gemcitabine, Dexamethasone, Platinol (Cisplatin)

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Crump et al. 2014 (NCIC-CTG LY.12) 2003-2011 Phase 3, fewer than 20 pts in this arm (E-switch-ic) DHAP Non-inferior ORR (co-primary endpoint)

Chemotherapy

Glucocorticoid therapy

21-day cycle for up to 3 cycles

References

  1. NCIC-CTG LY.12: Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. Epub 2014 Sep 29. link to original article contains dosing details in manuscript PubMed NCT00078949

Consolidation after salvage therapy

Fludarabine, Busulfan, Cyclophosphamide, then allo HSCT

FluBuCy: Fludarabine, Busulfan, Cyclophosphamide

Regimen variant #1, oral

Study Dates of enrollment Evidence
Glass et al. 2014 (DSHNHL R3) 2004-06-16 to 2009-03-24 Phase 2

Chemotherapy

Immunotherapy

GVHD prophylaxis

One course


Regimen variant #2, intravenous

Study Dates of enrollment Evidence
Glass et al. 2014 (DSHNHL R3) 2004-06-16 to 2009-03-24 Phase 2

Chemotherapy

Immunotherapy

GVHD prophylaxis

One course

References

  1. DSHNHL R3: Glass B, Hasenkamp J, Wulf G, Dreger P, Pfreundschuh M, Gramatzki M, Silling G, Wilhelm C, Zeis M, Görlitz A, Pfeiffer S, Hilgers R, Truemper L, Schmitz N; German High-Grade Lymphoma Study Group. Rituximab after lymphoma-directed conditioning and allogeneic stem-cell transplantation for relapsed and refractory aggressive non-Hodgkin lymphoma (DSHNHL R3): an open-label, randomised, phase 2 trial. Lancet Oncol. 2014 Jun;15(7):757-66. Epub 2014 May 11. link to original article contains dosing details in manuscript PubMed NCT00785330
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