Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia

PRIMARY OBJECTIVE: I. To compare the rate of molecular response 4.5 (MR4.5) after 12 months of combination therapy with ruxolitinib phosphate (ruxolitinib) plus a tyrosine‐kinase inhibitor (TKI) (bosutinib, dasatinib, imatinib or nilotinib) versus a TKI alone, based on local polymerase chain reaction (PCR) testing to measure BCR‐ABL transcripts in chronic phase chronic myelogenous leukemia (CML) patients with molecular evidence of disease. SECONDARY OBJECTIVES: I. To estimate the frequency and severity of toxicities of each regimen in this patient population. II. To estimate progression free survival and overall survival of each regimen in this patient population. ADDITIONAL OBJECTIVES: I. To describe patterns of MR4.5 and molecular response 4.0 (MR4.0) attainment and failure over the 3, 6, 9, and 12‐month time points of each regimen in this patient population. II. To evaluate drug compliance based on patient reported drug intake calendars in this patient population. III. 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. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive bosutinib orally (PO) daily or dasatinib PO daily or nilotinib PO twice daily (BID) or imatinib PO daily on days 1‐90. Treatment repeats every 90 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive ruxolitinib phosphate PO BID on days 1‐90, and bosutinib PO daily or dasatinib PO daily or nilotinib PO BID or imatinib PO daily on days 1‐90. Treatment repeats every 90 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 2 years, and then annually up to 5 years.