drugset / Trial / NCT03571321

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

NCT03571321

Phase 1 Recruiting 15 enrolled University of Chicago Incyte Corporation · collab
NaSequentialOpen-labelTreatment

Summary

This study will test if adding ruxolitinib to standard multi-drug chemotherapy regimen will be safe and tolerated in adolescents and young adults with newly diagnosed Ph-like acute lymphoblastic leukemia (ALL).

Timeline

Start
2019-05-28
Primary completion
2026-09-01
Completion
2027-09-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Ruxolitinib Small molecule 30 mg Oral
Subject Ruxolitinib Small molecule 40 mg Oral
Subject Ruxolitinib Small molecule 50 mg Oral
Background Cyclophosphamide Other / unclassified 1000 mg/m2 Intravenous
Background Cytarabine Small molecule 75 mg/m2 Intravenous
Background Dexamethasone Small molecule 6 mg/m2 Oral
Background Doxorubicin Other / unclassified 25 mg/m2 Intravenous
Background MERCAPTOPURINE ANHYDROUS Small molecule 75 mg/m2 Oral
Background Methotrexate Small molecule 15 mg Intrathecal
Background Methotrexate Small molecule 20 mg/m2 Oral
Background Methotrexate Small molecule 100 mg/m2 Intravenous
Background Pegaspargase Protein / enzyme biologic 2500 iu Intramuscular
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background Thioguanine Small molecule 60 mg/m2 Oral
Background Vincristine Small molecule 1.5 mg/m2 Intravenous