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A Randomized Phase II Study of Ruxolitinib (NSC-752295) in Combination With BCR-ABL Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia (CML) Patients With Molecular Evidence of Disease

Primary Objective To compare the rate of molecular response 4.5 (MR4.5) after 12 months of combination therapy with ruxolitinib plus a TKI (dasatinib or nilotinib) versus a TKI alone, based on local PCR testing to measure BCR-ABL transcripts in chronic phase CML patients with molecular evidence of disease. Secondary Objectives To estimate the frequency and severity of toxicities of each regimen in this patient population. To estimate progression free survival and overall survival of each regimen in this patient population. Additional Objectives To describe patterns of MR4.5 and MR4.0 attainment and failure over the 3, 6, 9, and 12-month time points of each regimen in this patient population. To evaluate drug compliance based on patient reported drug intake calendars in this patient population. To describe the kinetics of response in this patient population (as measured by quantitative BCR-ABL/BCR ratio) in both arms over the 3, 6, 9, and 12-month time points.

Phase

II

Recruitment Status

Current Studies