S1712, " A Randomized Phase II Study of Ruxolitinib in Combination with BCR-ABL Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia Patients with Evidence of Molecular Disease.- Study Chairs: Kendra Sweet, M.D., Jerald P. Radich, M.D.
This randomized phase II trial studies how well ruxolitinib phosphate and dasatinib or nilotinib work in treating patients with chronic myeloid leukemia. Ruxolitinib, dasatinib, and nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Primary Objective a. 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 a. To estimate the frequency and severity of toxicities of each regimen in this patient population. b. To estimate progression free survival and overall survival of each regimen in this patient population. Additional Objectives a. 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. b. To evaluate drug compliance based on patient reported drug intake calendars in this patient population. c. 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.
AMN107 (Nilotinib); Dasatinib (BMS-354825); Jakafi (Ruxolitinib); Nilotinib (); Ruxolitinib (); Tasigna (Nilotinib)
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