Difference between revisions of "Anaplastic large cell lymphoma, pediatric"
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[[#top|Back to Top]] | [[#top|Back to Top]] | ||
</div> | </div> | ||
− | {{#lst: | + | {{#lst:Editorial board transclusions|peds}} |
− | + | ''This page contains studies that were specific to pediatric populations. For the more general ALCL page, follow [[Anaplastic large cell lymphoma|this link]]. | |
{| class="wikitable" style="float:right; margin-right: 5px;" | {| class="wikitable" style="float:right; margin-right: 5px;" | ||
|- | |- | ||
Line 13: | Line 13: | ||
=Untreated= | =Untreated= | ||
==COG ANHL12P1 protocol {{#subobject:69ug1e|Regimen=1}}== | ==COG ANHL12P1 protocol {{#subobject:69ug1e|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#c8a2c8"> | |
− | |||
− | |||
− | |||
− | |||
{| class="wikitable sortable" style="width: 60%; text-align:center;" | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
!style="width: 33%"|Study | !style="width: 33%"|Study | ||
− | !style="width: 33%"| | + | !style="width: 33%"|Dates of enrollment |
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
|- | |- | ||
− | |[https:// | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8462406/ Lowe et al. 2021 (COG ANHL12P1)] |
|2013-2017 | |2013-2017 | ||
| style="background-color:#91cf61" |Randomized Phase 2 | | style="background-color:#91cf61" |Randomized Phase 2 | ||
Line 29: | Line 25: | ||
|} | |} | ||
''Note: there appear to be several dosing errors in Table 2; the authors have been contacted for clarification.'' | ''Note: there appear to be several dosing errors in Table 2; the authors have been contacted for clarification.'' | ||
− | ====Chemotherapy | + | <div class="toccolours" style="background-color:#eeeeee"> |
+ | ===Pre-phase {{#subobject:1yxa91|Variant=1}}=== | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
*[[Cyclophosphamide (Cytoxan)]] 200 mg/m<sup>2</sup> IV once per day on days 1 & 2 | *[[Cyclophosphamide (Cytoxan)]] 200 mg/m<sup>2</sup> IV once per day on days 1 & 2 | ||
+ | ====Glucocorticoid therapy==== | ||
*[[Dexamethasone (Decadron)]] 5 mg/m<sup>2</sup>/day PO on days 1 & 2, then 10 mg/m<sup>2</sup>/day PO on days 3 to 5 | *[[Dexamethasone (Decadron)]] 5 mg/m<sup>2</sup>/day PO on days 1 & 2, then 10 mg/m<sup>2</sup>/day PO on days 3 to 5 | ||
− | ====CNS prophylaxis==== | + | ====CNS therapy, prophylaxis==== |
*[[Methotrexate (MTX)]] age-based IT once on day 1 | *[[Methotrexate (MTX)]] age-based IT once on day 1 | ||
'''5-day course''' | '''5-day course''' | ||
− | ====Antibody-drug conjugate therapy | + | </div></div><br> |
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Induction {{#subobject:1yxa92|Variant=1}}=== | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Antibody-drug conjugate therapy==== | ||
*[[Brentuximab vedotin (Adcetris)]] 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes once on day 1 | *[[Brentuximab vedotin (Adcetris)]] 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes once on day 1 | ||
− | ====Chemotherapy | + | ====Chemotherapy==== |
*[[Methotrexate (MTX)]] 3000 mg/m<sup>2</sup> IV over 3 hours once on day 1 | *[[Methotrexate (MTX)]] 3000 mg/m<sup>2</sup> IV over 3 hours once on day 1 | ||
− | |||
*[[Ifosfamide (Ifex)]] as follows: | *[[Ifosfamide (Ifex)]] as follows: | ||
**Cycles 1, 3, 5: 800 mg/m<sup>2</sup> IV once per day on days 1 to 5 | **Cycles 1, 3, 5: 800 mg/m<sup>2</sup> IV once per day on days 1 to 5 | ||
Line 50: | Line 53: | ||
*[[Doxorubicin (Adriamycin)]] as follows: | *[[Doxorubicin (Adriamycin)]] as follows: | ||
**Cycles 2, 4, 6: 25 mg/m<sup>2</sup> IV once per day on days 4 & 5 | **Cycles 2, 4, 6: 25 mg/m<sup>2</sup> IV once per day on days 4 & 5 | ||
+ | ====Glucocorticoid therapy==== | ||
+ | *[[Dexamethasone (Decadron)]] 10 mg/m<sup>2</sup>/day PO on days 1 to 5 | ||
'''21-day cycle for 6 cycles''' | '''21-day cycle for 6 cycles''' | ||
+ | </div></div></div> | ||
===References=== | ===References=== | ||
− | #'''COG ANHL12P1:''' Lowe EJ, Reilly AF, Lim MS, Gross TG, Saguilig L, Barkauskas DA, Wu R, Alexander S, Bollard CM. Brentuximab vedotin in combination with chemotherapy for pediatric patients with ALK+ ALCL: results of COG trial ANHL12P1. Blood. 2021 Jul 1;137(26):3595-3603. [https://doi.org/10.1182/blood.2020009806 link to original article] '''contains | + | #'''COG ANHL12P1:''' Lowe EJ, Reilly AF, Lim MS, Gross TG, Saguilig L, Barkauskas DA, Wu R, Alexander S, Bollard CM. Brentuximab vedotin in combination with chemotherapy for pediatric patients with ALK+ ALCL: results of COG trial ANHL12P1. Blood. 2021 Jul 1;137(26):3595-3603. [https://doi.org/10.1182/blood.2020009806 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8462406/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33684925/ PubMed] [https://clinicaltrials.gov/study/NCT01979536 NCT01979536] |
+ | |||
==EICNHL ALCL99 protocol {{#subobject:69ug1e|Regimen=1}}== | ==EICNHL ALCL99 protocol {{#subobject:69ug1e|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#c8a2c8"> | |
− | |||
− | |||
− | |||
− | |||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 17%"|Study | !style="width: 17%"|Study | ||
− | !style="width: 15%"| | + | !style="width: 15%"|Dates of enrollment |
!style="width: 17%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 17%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 17%"|Comparator | !style="width: 17%"|Comparator | ||
Line 71: | Line 74: | ||
| style="background-color:#1a9851" |Randomized (E-switch-ic) | | style="background-color:#1a9851" |Randomized (E-switch-ic) | ||
|[[#EICNHL_ALCL99_protocol|EICHNL ALCL99]]; alternate MTX dosing | |[[#EICNHL_ALCL99_protocol|EICHNL ALCL99]]; alternate MTX dosing | ||
− | | style="background-color:#ffffbf" |Inconclusive whether non-inferior EFS | + | | style="background-color:#ffffbf" |Inconclusive whether non-inferior EFS (primary endpoint) |
| style="background-color:#1a9850" |Less toxic | | style="background-color:#1a9850" |Less toxic | ||
|- | |- | ||
|} | |} | ||
''Note: the intrathecal component is only described as "triple therapy" in the manuscript.'' | ''Note: the intrathecal component is only described as "triple therapy" in the manuscript.'' | ||
− | ====Chemotherapy | + | <div class="toccolours" style="background-color:#eeeeee"> |
+ | ===Pre-phase {{#subobject:1yxa91|Variant=1}}=== | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
*[[Cyclophosphamide (Cytoxan)]] 200 mg/m<sup>2</sup> IV once per day on days 1 & 2 | *[[Cyclophosphamide (Cytoxan)]] 200 mg/m<sup>2</sup> IV once per day on days 1 & 2 | ||
+ | ====Glucocorticoid therapy==== | ||
*[[Dexamethasone (Decadron)]] 5 mg/m<sup>2</sup>/day PO on days 1 & 2, then 10 mg/m<sup>2</sup>/day PO on days 3 to 5 | *[[Dexamethasone (Decadron)]] 5 mg/m<sup>2</sup>/day PO on days 1 & 2, then 10 mg/m<sup>2</sup>/day PO on days 3 to 5 | ||
− | ====CNS prophylaxis==== | + | ====CNS therapy, prophylaxis==== |
*[[Methotrexate (MTX)]] (dose not specified) IT once on day 1 | *[[Methotrexate (MTX)]] (dose not specified) IT once on day 1 | ||
*[[Cytarabine (Ara-C)]] (dose not specified) IT once on day 1 | *[[Cytarabine (Ara-C)]] (dose not specified) IT once on day 1 | ||
*[[Hydrocortisone (Cortef)]] (dose not specified) IT once on day 1 | *[[Hydrocortisone (Cortef)]] (dose not specified) IT once on day 1 | ||
− | |||
'''5-day course''' | '''5-day course''' | ||
− | + | </div></div><br> | |
− | ====Chemotherapy | + | <div class="toccolours" style="background-color:#eeeeee"> |
+ | ===Induction {{#subobject:1yjxo1|Variant=1}}=== | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
*[[Methotrexate (MTX)]] 3000 mg/m<sup>2</sup> IV over 3 hours once on day 1 | *[[Methotrexate (MTX)]] 3000 mg/m<sup>2</sup> IV over 3 hours once on day 1 | ||
− | |||
*[[Ifosfamide (Ifex)]] as follows: | *[[Ifosfamide (Ifex)]] as follows: | ||
**Cycles 1, 3, 5: 800 mg/m<sup>2</sup> IV once per day on days 1 to 5 | **Cycles 1, 3, 5: 800 mg/m<sup>2</sup> IV once per day on days 1 to 5 | ||
Line 99: | Line 107: | ||
*[[Doxorubicin (Adriamycin)]] as follows: | *[[Doxorubicin (Adriamycin)]] as follows: | ||
**Cycles 2, 4, 6: 25 mg/m<sup>2</sup> IV once per day on days 4 & 5 | **Cycles 2, 4, 6: 25 mg/m<sup>2</sup> IV once per day on days 4 & 5 | ||
+ | ====Glucocorticoid therapy==== | ||
+ | *[[Dexamethasone (Decadron)]] 10 mg/m<sup>2</sup>/day PO on days 1 to 5 | ||
'''21-day cycle for 6 cycles''' | '''21-day cycle for 6 cycles''' | ||
+ | </div></div></div> | ||
===References=== | ===References=== | ||
− | #'''EICNHL ALCL99:''' Brugières L, Le Deley MC, Rosolen A, Williams D, Horibe K, Wrobel G, Mann G, Zsiros J, Uyttebroeck A, Marky I, Lamant L, Reiter A. Impact of the methotrexate administration dose on the need for intrathecal treatment in children and adolescents with anaplastic large-cell lymphoma: results of a randomized trial of the EICNHL Group. J Clin Oncol. 2009 Feb 20;27(6):897-903. Epub 2009 Jan 12. [https://doi.org/10.1200/jco.2008.18.1487 link to original article] '''contains | + | #'''EICNHL ALCL99:''' Brugières L, Le Deley MC, Rosolen A, Williams D, Horibe K, Wrobel G, Mann G, Zsiros J, Uyttebroeck A, Marky I, Lamant L, Reiter A. Impact of the methotrexate administration dose on the need for intrathecal treatment in children and adolescents with anaplastic large-cell lymphoma: results of a randomized trial of the EICNHL Group. J Clin Oncol. 2009 Feb 20;27(6):897-903. Epub 2009 Jan 12. [https://doi.org/10.1200/jco.2008.18.1487 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/19139435/ PubMed] [https://clinicaltrials.gov/study/NCT00006455 NCT00006455] |
− | ==APO{{#subobject:6964de|Regimen=1}}== | + | ==APO {{#subobject:6964de|Regimen=1}}== |
− | |||
− | |||
− | |||
− | |||
APO: '''<u>A</u>'''driamycin (Doxorubicin), '''<u>P</u>'''rednisone, '''<u>O</u>'''ncovin (Vincristine) | APO: '''<u>A</u>'''driamycin (Doxorubicin), '''<u>P</u>'''rednisone, '''<u>O</u>'''ncovin (Vincristine) | ||
− | + | <br>HOP: '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''rednisone | |
− | HOP: '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''rednisone | + | <div class="toccolours" style="background-color:#eeeeee"> |
− | < | ||
===Regimen {{#subobject:985a91|Variant=1}}=== | ===Regimen {{#subobject:985a91|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 60%; text-align:center;" | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
!style="width: 33%"|Study | !style="width: 33%"|Study | ||
− | !style="width: 33%"| | + | !style="width: 33%"|Dates of enrollment |
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
|- | |- | ||
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4682366/ Alexander et al. 2014 (COG ANHL0131)] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4682366/ Alexander et al. 2014 (COG ANHL0131)] | ||
|2004-2008 | |2004-2008 | ||
− | | style="background-color:#91cf61" |Non-randomized | + | | style="background-color:#91cf61" |Non-randomized part of phase 3 RCT |
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Doxorubicin (Adriamycin)]] 75 mg/m<sup>2</sup> IV once per day on days 1 & 22 | *[[Doxorubicin (Adriamycin)]] 75 mg/m<sup>2</sup> IV once per day on days 1 & 22 | ||
+ | *[[Vincristine (Oncovin)]] 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once per day on days 1, 8, 15, 22, 29 | ||
+ | ====Glucocorticoid therapy==== | ||
*[[Prednisone (Sterapred)]] 40 mg/m<sup>2</sup>/day PO on days 1 to 28 | *[[Prednisone (Sterapred)]] 40 mg/m<sup>2</sup>/day PO on days 1 to 28 | ||
− | + | ====CNS therapy, prophylaxis==== | |
− | ====CNS prophylaxis==== | ||
*[[Methotrexate (MTX)]] age-adjusted IT once per day on days 1, 8, 22 | *[[Methotrexate (MTX)]] age-adjusted IT once per day on days 1, 8, 22 | ||
'''6-week course''' | '''6-week course''' | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#cbd5e7"> | ||
====Subsequent treatment==== | ====Subsequent treatment==== | ||
− | *APO versus APV maintenance | + | *[[#APO_888|APO]] versus [[#APV|APV]] maintenance |
+ | </div></div> | ||
===References=== | ===References=== | ||
− | # '''COG ANHL0131:''' Alexander S, Kraveka JM, Weitzman S, Lowe E, Smith L, Lynch JC, Chang M, Kinney MC, Perkins SL, Laver J, Gross TG, Weinstein H. Advanced stage anaplastic large cell lymphoma in children and adolescents: results of ANHL0131, a randomized phase III trial of APO versus a modified regimen with vinblastine: a report from the children's oncology group. Pediatr Blood Cancer. 2014 Dec;61(12):2236-42. Epub 2014 Aug 23. [https:// | + | # '''COG ANHL0131:''' Alexander S, Kraveka JM, Weitzman S, Lowe E, Smith L, Lynch JC, Chang M, Kinney MC, Perkins SL, Laver J, Gross TG, Weinstein H. Advanced stage anaplastic large cell lymphoma in children and adolescents: results of ANHL0131, a randomized phase III trial of APO versus a modified regimen with vinblastine: a report from the children's oncology group. Pediatr Blood Cancer. 2014 Dec;61(12):2236-42. Epub 2014 Aug 23. [https://doi.org/10.1002/pbc.25187 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4682366/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/25156886/ PubMed] [https://clinicaltrials.gov/study/NCT00059839 NCT00059839] |
+ | |||
=Relapsed or refractory, subsequent lines of therapy= | =Relapsed or refractory, subsequent lines of therapy= | ||
==Crizotinib monotherapy {{#subobject:be5391|Regimen=1}}== | ==Crizotinib monotherapy {{#subobject:be5391|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
− | |||
− | |||
===Regimen {{#subobject:e9c195|Variant=1}}=== | ===Regimen {{#subobject:e9c195|Variant=1}}=== | ||
{| class="wikitable" style="color:white; background-color:#404040" | {| class="wikitable" style="color:white; background-color:#404040" | ||
Line 147: | Line 156: | ||
{| class="wikitable sortable" style="width: 60%; text-align:center;" | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
!style="width: 33%"|Study | !style="width: 33%"|Study | ||
− | !style="width: 33%"| | + | !style="width: 33%"|Dates of enrollment |
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
|- | |- | ||
Line 156: | Line 165: | ||
|} | |} | ||
''Note: this was an expansion cohort of a phase 1/2 study.'' | ''Note: this was an expansion cohort of a phase 1/2 study.'' | ||
+ | <div class="toccolours" style="background-color:#fdcdac"> | ||
====Biomarker eligibility criteria==== | ====Biomarker eligibility criteria==== | ||
*ALK rearrangement | *ALK rearrangement | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
− | *[[Crizotinib (Xalkori)]] 280 mg/m<sup>2</sup> PO twice per day | + | *[[Crizotinib (Xalkori)]] 280 mg/m<sup>2</sup> PO twice per day on days 1 to 28 |
'''28-day cycles''' | '''28-day cycles''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | # '''COG ADVL0912:''' Mossé YP, Lim MS, Voss SD, Wilner K, Ruffner K, Laliberte J, Rolland D, Balis FM, Maris JM, Weigel BJ, Ingle AM, Ahern C, Adamson PC, Blaney SM. Safety and activity of crizotinib for paediatric patients with refractory solid tumours or anaplastic large-cell lymphoma: a Children's Oncology Group phase 1 consortium study. Lancet Oncol. 2013 May;14(6):472-80. Epub 2013 Apr 16. [https://doi.org/10.1016/s1470-2045(13)70095-0 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3730818/ link to PMC article] '''contains | + | # '''COG ADVL0912:''' Mossé YP, Lim MS, Voss SD, Wilner K, Ruffner K, Laliberte J, Rolland D, Balis FM, Maris JM, Weigel BJ, Ingle AM, Ahern C, Adamson PC, Blaney SM. Safety and activity of crizotinib for paediatric patients with refractory solid tumours or anaplastic large-cell lymphoma: a Children's Oncology Group phase 1 consortium study. Lancet Oncol. 2013 May;14(6):472-80. Epub 2013 Apr 16. [https://doi.org/10.1016/s1470-2045(13)70095-0 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3730818/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/23598171/ PubMed] [https://clinicaltrials.gov/study/NCT00939770 NCT00939770] |
[[Category:Anaplastic large cell lymphoma regimens]] | [[Category:Anaplastic large cell lymphoma regimens]] | ||
[[Category:Disease-specific pages]] | [[Category:Disease-specific pages]] | ||
[[Category:T-cell lymphomas]] | [[Category:T-cell lymphomas]] | ||
[[Category:Pediatric hematologic neoplasms]] | [[Category:Pediatric hematologic neoplasms]] |
Revision as of 00:25, 4 July 2024
Section editor | |
---|---|
David Noyd, MD, MPH University of Washington Seattle, WA, USA |
This page contains studies that were specific to pediatric populations. For the more general ALCL page, follow this link.
3 regimens on this page
5 variants on this page
|
Untreated
COG ANHL12P1 protocol
Study | Dates of enrollment | Evidence |
---|---|---|
Lowe et al. 2021 (COG ANHL12P1) | 2013-2017 | Randomized Phase 2 |
Note: there appear to be several dosing errors in Table 2; the authors have been contacted for clarification.
Pre-phase
Chemotherapy
- Cyclophosphamide (Cytoxan) 200 mg/m2 IV once per day on days 1 & 2
Glucocorticoid therapy
- Dexamethasone (Decadron) 5 mg/m2/day PO on days 1 & 2, then 10 mg/m2/day PO on days 3 to 5
CNS therapy, prophylaxis
- Methotrexate (MTX) age-based IT once on day 1
5-day course
Induction
Antibody-drug conjugate therapy
- Brentuximab vedotin (Adcetris) 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes once on day 1
Chemotherapy
- Methotrexate (MTX) 3000 mg/m2 IV over 3 hours once on day 1
- Ifosfamide (Ifex) as follows:
- Cycles 1, 3, 5: 800 mg/m2 IV once per day on days 1 to 5
- Etoposide (Vepesid) as follows:
- Cycles 1, 3, 5: 100 mg/m2 IV once per day on days 4 & 5
- Cytarabine (Ara-C) as follows:
- Cycles 1, 3, 5: 150 mg/m2 IV every 12 hours on days 4 & 5 (total dose per cycle: 600 mg/m2)
- Cyclophosphamide (Cytoxan) as follows:
- Cycles 2, 4, 6: 200 mg/m2 IV once per day on days 1 to 5
- Doxorubicin (Adriamycin) as follows:
- Cycles 2, 4, 6: 25 mg/m2 IV once per day on days 4 & 5
Glucocorticoid therapy
- Dexamethasone (Decadron) 10 mg/m2/day PO on days 1 to 5
21-day cycle for 6 cycles
References
- COG ANHL12P1: Lowe EJ, Reilly AF, Lim MS, Gross TG, Saguilig L, Barkauskas DA, Wu R, Alexander S, Bollard CM. Brentuximab vedotin in combination with chemotherapy for pediatric patients with ALK+ ALCL: results of COG trial ANHL12P1. Blood. 2021 Jul 1;137(26):3595-3603. link to original article contains dosing details in manuscript link to PMC article PubMed NCT01979536
EICNHL ALCL99 protocol
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy | Comparative Toxicity |
---|---|---|---|---|---|
Brugières et al. 2009 (EICNHL ALCL99) | 1999-2005 | Randomized (E-switch-ic) | EICHNL ALCL99; alternate MTX dosing | Inconclusive whether non-inferior EFS (primary endpoint) | Less toxic |
Note: the intrathecal component is only described as "triple therapy" in the manuscript.
Pre-phase
Chemotherapy
- Cyclophosphamide (Cytoxan) 200 mg/m2 IV once per day on days 1 & 2
Glucocorticoid therapy
- Dexamethasone (Decadron) 5 mg/m2/day PO on days 1 & 2, then 10 mg/m2/day PO on days 3 to 5
CNS therapy, prophylaxis
- Methotrexate (MTX) (dose not specified) IT once on day 1
- Cytarabine (Ara-C) (dose not specified) IT once on day 1
- Hydrocortisone (Cortef) (dose not specified) IT once on day 1
5-day course
Induction
Chemotherapy
- Methotrexate (MTX) 3000 mg/m2 IV over 3 hours once on day 1
- Ifosfamide (Ifex) as follows:
- Cycles 1, 3, 5: 800 mg/m2 IV once per day on days 1 to 5
- Etoposide (Vepesid) as follows:
- Cycles 1, 3, 5: 100 mg/m2 IV once per day on days 4 & 5
- Cytarabine (Ara-C) as follows:
- Cycles 1, 3, 5: 150 mg/m2 IV every 12 hours on days 4 & 5 (total dose per cycle: 600 mg/m2)
- Cyclophosphamide (Cytoxan) as follows:
- Cycles 2, 4, 6: 200 mg/m2 IV once per day on days 1 to 5
- Doxorubicin (Adriamycin) as follows:
- Cycles 2, 4, 6: 25 mg/m2 IV once per day on days 4 & 5
Glucocorticoid therapy
- Dexamethasone (Decadron) 10 mg/m2/day PO on days 1 to 5
21-day cycle for 6 cycles
References
- EICNHL ALCL99: Brugières L, Le Deley MC, Rosolen A, Williams D, Horibe K, Wrobel G, Mann G, Zsiros J, Uyttebroeck A, Marky I, Lamant L, Reiter A. Impact of the methotrexate administration dose on the need for intrathecal treatment in children and adolescents with anaplastic large-cell lymphoma: results of a randomized trial of the EICNHL Group. J Clin Oncol. 2009 Feb 20;27(6):897-903. Epub 2009 Jan 12. link to original article contains dosing details in manuscript PubMed NCT00006455
APO
APO: Adriamycin (Doxorubicin), Prednisone, Oncovin (Vincristine)
HOP: Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisone
Regimen
Study | Dates of enrollment | Evidence |
---|---|---|
Alexander et al. 2014 (COG ANHL0131) | 2004-2008 | Non-randomized part of phase 3 RCT |
Chemotherapy
- Doxorubicin (Adriamycin) 75 mg/m2 IV once per day on days 1 & 22
- Vincristine (Oncovin) 1.5 mg/m2 (maximum dose of 2 mg) IV once per day on days 1, 8, 15, 22, 29
Glucocorticoid therapy
- Prednisone (Sterapred) 40 mg/m2/day PO on days 1 to 28
CNS therapy, prophylaxis
- Methotrexate (MTX) age-adjusted IT once per day on days 1, 8, 22
6-week course
References
- COG ANHL0131: Alexander S, Kraveka JM, Weitzman S, Lowe E, Smith L, Lynch JC, Chang M, Kinney MC, Perkins SL, Laver J, Gross TG, Weinstein H. Advanced stage anaplastic large cell lymphoma in children and adolescents: results of ANHL0131, a randomized phase III trial of APO versus a modified regimen with vinblastine: a report from the children's oncology group. Pediatr Blood Cancer. 2014 Dec;61(12):2236-42. Epub 2014 Aug 23. link to original article link to PMC article contains dosing details in manuscript PubMed NCT00059839
Relapsed or refractory, subsequent lines of therapy
Crizotinib monotherapy
Regimen
FDA-recommended dose |
Study | Dates of enrollment | Evidence |
---|---|---|
Mossé et al. 2013 (COG ADVL0912) | 2009-2012 | Phase 1/2 (RT) |
Note: this was an expansion cohort of a phase 1/2 study.
Biomarker eligibility criteria
- ALK rearrangement
References
- COG ADVL0912: Mossé YP, Lim MS, Voss SD, Wilner K, Ruffner K, Laliberte J, Rolland D, Balis FM, Maris JM, Weigel BJ, Ingle AM, Ahern C, Adamson PC, Blaney SM. Safety and activity of crizotinib for paediatric patients with refractory solid tumours or anaplastic large-cell lymphoma: a Children's Oncology Group phase 1 consortium study. Lancet Oncol. 2013 May;14(6):472-80. Epub 2013 Apr 16. link to original article link to PMC article contains dosing details in manuscript PubMed NCT00939770