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Trial Summary


Protocol No.PHO-FALON-INCYTE-AALL1521
StatusOPEN TO ACCRUAL
Principal InvestigatorMueller, Emily
ScopeNational
PhasePhase II
Age GroupChildren
TitleA 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
DescriptionThis 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.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • 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
  • 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 alterations (eg, JAK2 fusions, erythropoietin receptor (EPO-R) fusions, SH2B3 deletions, interleukin-7 receptor-alpha (IL7RA) mutations) with or without CRLF2 rearrangement
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesLeukemia, other
Participating InstitutionsIndiana University (IU)
    Treatment TypeTreatment
    ContactJennifer Pencek, RN, BSNPhone: +1 317-944-2832
    Pager:
    Email: jpencek@iupui.edu