A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia


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Trial ID: NCT02723994


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

Stanford Investigator(s)


Inclusion Criteria:

   - 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 × 10^3/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

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

   - Calculated creatinine clearance or radioisotope glomerular filtration rate < 70
   mL/min/1.73 m^2

   - 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 × 10^3/μL

   - Absolute neutrophil count (ANC) < 750/μL

   - Positive screen for hepatitis B or C

   - Known human immunodeficiency virus infection


drug: Ruxolitinib

drug: Asparaginase Erwinia Chrysanthemi

drug: Cyclophosphamide

drug: Cytarabine

drug: Dexamethasone

drug: Doxorubicin

drug: Leucovorin Calcium

drug: Mercaptopurine

drug: Methotrexate

drug: Pegaspargase

drug: Prednisone

drug: Thioguanine

drug: Vincristine Sulfate


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Zeel Patel

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