Anaplastic large cell lymphoma, pediatric
This page contains studies that were specific to pediatric populations. For the more general ALCL page, follow this link.
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Section editor | |
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David Noyd, MD, MPH University of Washington Seattle, WA, USA |
Last updated on 2024-07-23: 4 regimens on this page
4 variants on this page
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Untreated
COG ANHL12P1 protocol
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
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Lowe et al. 2021 (COG ANHL12P1) | 2013-2017 | Randomized Phase 2 | Chemotherapy + Brentuximab vedotin (Adcetris) vs Chemotherapy + Crizotinib (Xalkori) | Chemotherapy + Brentuximab vedotin (Adcetris) 2-year Overall Survival 97% (95%CI 88-99%), Event Free Survival 79% (95% CI 67-87%) (Ref 1) Crizotinib (Xalkori) arm with similar OS/EFS, but increased risk of thromboembolic events (Ref 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/dose IV once per day over 15 to 30 minutes on days 1 & 2
Glucocorticoid therapy
- Dexamethasone (Decadron) 5 mg/m2/dose PO/IV once daily on days 1 & 2, then 5 mg/m2/dose PO twice daily on days 3 to 5
CNS therapy, prophylaxis
- Methotrexate (MTX) age-based IT once on day 1
- Cytarabine (Ara-C) age-based IT once on day 1
- Hydrocortisone (Cortef) age-based IT once on day 1
5-day course
Induction
Antibody-drug conjugate therapy
- Brentuximab vedotin (Adcetris) 1.8 mg/kg/dose (maximum dose of 180 mg) IV over 30 minutes once on day 1
Chemotherapy
- Methotrexate (MTX) 3000 mg/m2/dose IV over 3 hours once on day 1
- Ifosfamide (Ifex) as follows:
- Cycles 1, 3, 5: 800 mg/m2/dose IV over 1 hour once per day on days 1 to 5
- Etoposide (Vepesid) as follows:
- Cycles 1, 3, 5: 100 mg/m2/dose IV over 2 hours once per day on days 4 & 5
- Cytarabine (Ara-C) as follows:
- Cycles 1, 3, 5: 150 mg/m2/dose IV over 1 to 30 minutes every 12 hours on days 4 & 5 for a total of 4 doses (total dose per cycle: 600 mg/m2)
- Cyclophosphamide (Cytoxan) as follows:
- Cycles 2, 4, 6: 200 mg/m2/dose IV over 15 to 30 minutes once per day on days 1 to 5
- Doxorubicin (Adriamycin) as follows:
- Cycles 2, 4, 6: 25 mg/m2/dose IV over 1 to 15 minutes once per day on days 4 & 5
Glucocorticoid therapy
- Dexamethasone (Decadron) 5 mg/m2/dose PO/IV twice daily on days 1 to 5
Supportive therapy
- Leucovorin (Folinic acid) 15 mg/m2/dose IV or PO every 6 hours beginning 24 hours after the start of IV Methotrexate (MTX) until Methotrexate (MTX) level falls below 0.1μM/L
- Mesna (Mesnex) 160 mg/m2/dose (480 mg/m2/day) IV at hours 0, 4, and 8 following each dose of Ifosfamide (Ifex)
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 dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT01979536
- COG ANHL12P1: Lowe EJ, Reilly AF, Lim MS, Gross TG, Saguilig L, Barkauskas DA, Wu R, Alexander S, Bollard CM. Crizotinib in Combination With Chemotherapy for Pediatric Patients With ALK+ Anaplastic Large-Cell Lymphoma: The Results of Children's Oncology Group Trial ANHL12P1. J Clin Oncol. 2023 Apr 10;41(11):2043-2053. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT01979536
Relapsed or refractory, subsequent lines of therapy
Crizotinib monotherapy
Regimen
FDA-recommended dose |
Study | Dates of enrollment | Evidence |
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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 dosing details in manuscript have been reviewed by our editors PubMed NCT00939770