Phase 1 Study of Adding Ruxolitinib to Pediatric-Based Chemotherapy for Adults 18 to 39 Years Old With Ph-like Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating the safety and tolerability of adding ruxolitinib to a standard multi-drug chemotherapy regimen in adolescents and young adults newly diagnosed with Ph-like acute lymphoblastic leukemia ALL. This phase I trial focuses on patients aged 18 to 39 years and aims to determine the side effects when ruxolitinib is combined with pediatric-based chemotherapy for this specific leukemia subtype. Participants receive ruxolitinib by mouth at one of three doses 30 mg, 40 mg, or 50 mg during distinct chemotherapy phases including remission consolidation, interim maintenance, delayed intensification, and maintenance therapy. The chemotherapy regimen includes multiple drugs such as cyclophosphamide, cytarabine, mercaptopurine, vincristine, pegaspargase, rituximab for CD20 positive cases, methotrexate both intrathecal and intravenous, dexamethasone, doxorubicin, thioguanine, and oral methotrexate, administered over various schedules and durations up to 2-3 years. Prior to study entry, participants must have completed a 4-drug induction therapy with intrathecal chemotherapy. During the study, researchers monitor participants through assessments of side effects over 24 weeks and measure outcomes such as minimal residual disease negativity at 4 weeks, overall survival, and event-free survival over 2 years. Participants undergo regular evaluations for side effects and disease status while receiving the combined treatment. The total involvement may last several years due to extended maintenance therapy and follow-up to assess long-term outcomes.

Ruxolitinib and Chemotherapy in Adolescents and Young Adults With Ph-like Acute Lymphoblastic Leukemia