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

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.

Eligibility

• Ages 1 to 21 years of age
• De novo high-risk (HR) Ph-like B-ALL for which any of the 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
• 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

Contact

For additional study information, please contact Heather Rogers:

• Phone: 352-294-8743
• Email: heatherrogers@ufl.edu