AALL1521, A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK PathwayMutant Acute Lymphoblastic Leukemia

This is a nonrandomized study of ruxolitinib in combination with a standard multi-agent chemotherapy regimen for the treatment of B-cell acute lymphoblastic leukemia. Part 1 of the study will optimize the dose of study drug (ruxolitinib) in combination with the chemotherapy regimen. Part 2 will evaluate the efficacy of combination chemotherapy and ruxolitinib at the recommended dose determined in Part 1.

Principal Investigator:
Van Huynh, MD

Research Coordinator:
Kathryn Duvall
(714) 509-8646

Visit clinicaltrials.gov for more information about this trial.



  • Clinical Trial Info
  • IRB Number: 160659
  • Sponsor: Incyte-COG
  • Protocol Number: AALL1521
  • NCT Number: NCT02723994
  • Research Type: Adolescents and Young Adults, Leukemia
  • Phase: II
  • Status: Active

Key Inclusion Criteria:

  • Ages 2 years to 21 years
  • De novo high-risk (HR) Ph-like B-ALL
  • One of the following Ph-like ALL genetic lesions must be present in the diagnostic bone marrow or peripheral blood sample:
    CRLF2 rearrangement with JAK1 or JAK2 mutation (JAK+), CRLF2 rearrangement without JAK mutation, other JAK pathway alteration
  • Completed a 4-drug Induction therapy regimen (modified aBFM regimen or equivalent) in for HR B-ALL and have had end-Induction minimal residual disease (MRD) assessed
  • Standard COG organ function

Key Exclusion Criteria:

  • Receipt of any other cytotoxic chemotherapy before Induction therapy, with exception of hydroxyurea or steroid pretreatment
  • Trisomy 21 (Down syndrome)
  • BCR-ABL1-rearranged (Ph+) ALL

Long Live Childhood

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