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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: acute lymphoblastic leukemia
  • Age: Between 1 - 21 Years
  • Gender: Male or Female

Inclusion 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/?L
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
Completed a 4-drug Induction therapy regimen (modified aBFM regimen or equivalent) in Study AALL1131 or as 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 (except pre-Induction hydroxyurea or steroid pretreatment)
BCR-ABL1-rearranged ALL
Trisomy 21 (Down syndrome)
History or evidence of cirrhosis
Positive screen for hepatitis B or C
Known human immunodeficiency virus infection

Recruitment Status

Open

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