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Information is also accessible through the patient and families tab. Family friendly summaries are created and reviewed by our advocacy partners. The information is updated to the best of our knowledge but might not reflect the latest information. Note that most studies are only available at a limited number of sites, please click on ‘further information’ for details. Studies, particularly early phase trials, may also temporarily close to enrolment or not have slots available for all treatment groups. In all cases, study teams at individual C17 centres will have the most up-to-date information.

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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 Pathway-Mutant Acute Lymphoblastic Leukemia

Closed to enrollment

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 Pathway-Mutant Acute Lymphoblastic Leukemia

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DiagnosisALL, B-cell acute lymphoblastic leukemiaStudy StatusClosed to enrollment
AgeChild, Adult - (2 years to 21 years)RandomisationN/A
Line of treatmentFirst line treatment
Routes of Treatment AdministrationRuxolitinib - oral; Other drugs are given as usually administered for leukemia therapy
Last Posted Update2023-11-09 #NCT02723994
International Sponsor
Incyte Corporation
Principal Investigators for Canadian Sites
BC Children's Hospital – Dr. David Dix
Montreal Children's Hospital – Dr. Sharon Abish
Alberta Children's Hospital – Dr. Victor Lewis
The Hospital for Sick Children – Dr. Ute Bartels
Hamilton Health Sciences Centre, McMaster University - Dr. Carol Portwine
CHU Ste Justine - Dr. Thai Tran

Medical contact
Rebecca Deyell


Social worker/patient navigator contact
Ilana Katz 


Clinical research contact
Hem/Onc/BMT Clinical Trials Unit


Medical contact
Clinical Research Unit
Social worker/patient navigator contact
Clinical Research Unit
Clinical research contact
Stephanie Badour
Medical contact

Dr. Daniel Morgenstern

Social worker/patient navigator contact

Karen Fung

Clinical research contact

New Agent and Innovative Therapies (NAIT)


Medical contact
Dr. Victor Lewis


Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact
Dr. Carol Portwine
Social worker/patient navigator contact
Jane Cassano 
Clinical research contact
Sabrina Millson
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
Social worker/patient navigator contact
Marie-Claude Charrette
Clinical research contact
Marie Saint-Jacques



Study Description

Brief Summary:

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.

Inclusion Criteria
  • Eligible for study when participant is 1 year to 21 years at the time of diagnosis
  • Eligible Ages in Australia and 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