for people ages 1-21 (full criteria)
study started
completion around



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.

Official Title

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


Leukemia, B-cell acute lymphoblastic leukemia (ALL), pediatric, multi-agent chemotherapy, JAK inhibitor, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoid Leukemia, Leucovorin, Cytarabine, Dexamethasone, Prednisone, Cyclophosphamide, Doxorubicin, Methotrexate, Vincristine, Asparaginase, Mercaptopurine, Pegaspargase, Thioguanine, Levoleucovorin, Ruxolitinib, Asparaginase Erwinia Chrysanthemi, Leucovorin Calcium, Vincristine Sulfate


You can join if…

Open to people ages 1-21

  • Eligible for study when participant is 1 year to 21 years at the time of diagnosis
  • Eligible Ages in Canada; 2 years to 21 years
  • De novo high-risk (HR) Ph-like B-ALL for which any of following criteria are present at diagnosis:
    • Age ≥ 10 years
    • White blood cell (WBC) ≥ 50 × 103/μL
    • CNS3 leukemia at diagnosis
    • Systemic steroid pretreatment without presteroid WBC documentation
  • Diagnostic bone marrow or peripheral blood sample must have gene expression profiling and downstream genetic testing performed by submitting diagnostic specimens under the COG AALL08B1 or APEC14B1 biology studies, or AALL1131 or its successor study. Specimens must demonstrate a Ph-like expression profile (ie, LDA-positive) as tested by low density microarray testing at the COG ALL reference laboratory or TriCore laboratory at the University of New Mexico AND must contain 1 of the following genetic lesions: (determined at COG ALL reference laboratories, or equivalent CAP/CLIA-certified laboratories approved by the medical monitor:
    1. CRLF2 rearrangement with confirmed JAK1 or JAK2 mutation (JAK+)
    2. CRLF2 rearrangement without JAK mutation
    3. Other JAK pathway alterations (eg, JAK2 fusions, EPOR fusions, SH2B3 deletions, IL7RA mutations) with or without CRLF2-R, or CRLF2-R with unknown JAK status as determined by a COG ALL Reference Laboratory
  • Completed a 4-drug Induction therapy regimen (modified aBFM regimen or equivalent) in Study AALL1131 or its successor study, or as per the institutional standard of care for HR B-ALL and have had end-Induction minimal residual disease (MRD) assessed
  • Male and female subjects of reproductive non childbearing potential or willing to take appropriate precautions to avoid pregnancy or fathering a child for the duration of study participation

You CAN'T join if...

  • 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
  • Calculated creatinine clearance or radioisotope glomerular filtration rate < 70 mL/min/1.73 m2
  • Alanine aminotransferase ≥ 5 × upper limit of normal (ULN) for age
  • Direct bilirubin ≥ 1.5 × ULN (may be assumed if total bilirubin is below ULN)
  • History or evidence of cirrhosis
  • Platelet count < 75 × 103/μL
  • Absolute neutrophil count (ANC) < 750/μL
  • Positive screen for hepatitis B or C
  • Known human immunodeficiency virus infection


  • Ucsf Pediatric Oncology
    San Francisco California 94158 United States
  • Kaiser Permanente
    San Diego California 92111 United States
  • Rady Children'S Hospital - San Diego
    San Diego California 92123 United States
  • Children'S Hospital Los Angeles
    Los Angeles California 90027 United States
  • Kaiser Foundation Health Plan
    Los Angeles California 90027 United States
  • Southern California Permanente Medical Group
    Los Angeles California 90027 United States
  • Choc Children Hospital
    Orange California 92868 United States
  • Valley Childrens Hospital
    Madera California 93636-8762 United States
  • Miller Childrens Hospital Pharmacy
    Long Beach California 90806 United States
  • Kaiser Permanente Downey
    Santa Fe Springs California 90670 United States


in progress, not accepting new patients
Start Date
Completion Date
Incyte Corporation
Phase 2 research study
Study Type
About 171 people participating
Last Updated