Acute lymphoblastic leukemia, infant

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


This page contains studies that are specific to populations with infant ALL, which is characterized by KMT2A rearrangements. For the more general B-cell pediatric acute lymphoblastic leukemia page, follow this link.
Are you looking for a regimen but can't find it here? It is possible that we've moved it to the historical regimens page.

1 regimens on this page
1 variants on this page


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.



Blinatumomab monotherapy


Study Dates of enrollment Evidence
van der Sluis et al. 2023 2018-07 to 2021-07 Phase 2

Preceding treatment


Supportive therapy

CNS prophylaxis

28-day course

Subsequent treatment

  • Interfant-06 consolidation


  1. van der Sluis IM, de Lorenzo P, Kotecha RS, Attarbaschi A, Escherich G, Nysom K, Stary J, Ferster A, Brethon B, Locatelli F, Schrappe M, Scholte-van Houtem PE, Valsecchi MG, Pieters R. Blinatumomab Added to Chemotherapy in Infant Lymphoblastic Leukemia. N Engl J Med. 2023 Apr 27;388(17):1572-1581. link to original article PubMed EudraCT 2016-004674-17

Cyclophosphamide, Etoposide, Methotrexate


Study Dates of enrollment Evidence Comparator Comparative Efficacy
Dreyer et al. 2014 (COG P9407) 2001-2006 Non-randomized
Brown et al. 2021 (COG AALL0631) 2008-2014 Phase 3 (C) Cyclophosphamide, Etoposide, Lestaurtinib, Methotrexate Did not meet primary endpoint of EFS

Biomarker eligibility criteria

  • COG AALL0631: KMT2A rearrangement

Preceding treatment

  • Induction


  • Cyclophosphamide (Cytoxan) 300 mg/m2 IV over 30 minutes once per day on days 15 to 19
  • Etoposide (Vepesid) 100 mg/m2 IV over 2 hours once per day on days 15 to 19
  • Methotrexate (MTX) 200 mg/m2 IV over 20 minutes, then 3800 mg/m2 IV continuous infusion over 23.67 hours, repeated on days 1 & 8 (total dose: 8000 mg/m2)

Subsequent treatment

  • Reinduction


  1. COG P9407: Dreyer ZE, Hilden JM, Jones TL, Devidas M, Winick NJ, Willman CL, Harvey RC, Chen IM, Behm FG, Pullen J, Wood BL, Carroll AJ, Heerema NA, Felix CA, Robinson B, Reaman GH, Salzer WL, Hunger SP, Carroll WL, Camitta BM. Intensified chemotherapy without SCT in infant ALL: results from COG P9407 (Cohort 3). Pediatr Blood Cancer. 2015 Mar;62(3):419-26. Epub 2014 Nov 14. link to original article link to PMC article PubMed NCT00002756
  2. COG AALL0631: Brown PA, Kairalla JA, Hilden JM, Dreyer ZE, Carroll AJ, Heerema NA, Wang C, Devidas M, Gore L, Salzer WL, Winick NJ, Carroll WL, Raetz EA, Borowitz MJ, Small D, Loh ML, Hunger SP. FLT3 inhibitor lestaurtinib plus chemotherapy for newly diagnosed KMT2A-rearranged infant acute lymphoblastic leukemia: Children's Oncology Group trial AALL0631. Leukemia. 2021 May;35(5):1279-1290. Epub 2021 Feb 23. Erratum in: Leukemia. 2021 Apr 12. link to original article contains dosing details in supplement link to PMC article PubMed NCT00557193