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
David Noyd, MD, MPH
University of Washington
Seattle, WA, USA

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Last updated on 2024-07-23:
4 regimens on this page
4 variants on this page


Untreated

COG ANHL12P1 protocol

Study Dates of enrollment Evidence Comparator Comparative Efficacy
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

Glucocorticoid therapy

CNS therapy, prophylaxis

5-day course


Induction

Antibody-drug conjugate therapy

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

Supportive therapy

21-day cycle for 6 cycles

References

  1. 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
  2. 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
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

Targeted therapy

28-day cycles

References

  1. 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