A MULTICENTER PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF BOSUTINIB VERSUS IMATINIB IN ADULT PATIENTS WITH NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOGENOUS LEUKEMIA
A MULTICENTER PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF BOSUTINIB VERSUS IMATINIB IN ADULT PATIENTS WITH NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOGENOUS LEUKEMIA
Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study.
The study will be open for enrollment until the planned number of approximately 500 Philadelphia Chromosome Positive (Ph+) patients have been randomized (approximately 250 Ph+ patients in each treatment arm; a total of approximately 530 Ph+ and Ph- patients). All patients will be treated and/or followed for approximately 5 years (240 weeks) after randomization until the study has closed. Patients who discontinue study therapy early due to disease progression or intolerance to study medication will continue to be followed yearly for survival for up to approximately 5 years (240 weeks) after randomization.
Inclusion Criteria:
Exclusion Criteria:
Indianapolis, Indiana 46237, United States
Lafayette, Louisiana 70503, United States
Worcester, Massachusetts 01655, United States
Grosse Pointe Woods, Michigan 48236, United States
Tupelo, Mississippi 38801, United States
Hackensack, New Jersey 07601, United States
Charleston, South Carolina 29425, United States
Green Bay, Wisconsin 54301, United States
Green Bay, Wisconsin 54303, United States
Bonn, Rhineland-Palatinate 53105, Germany
Jena Lobeda-Ost, 07747, Germany
Debrecen, 4032, Hungary
Győr, 9023, Hungary
Szeged, 6725, Hungary
Catania, CT 95123, Italy
Gdansk, Pomeranian Voivodeship 80-214, Poland
Katowice, 40032, Poland
Lodz, 93510, Poland
Pretoria, Gauteng 0002, South Africa
Muang, Chiang Mai 50200, Thailand
Bangkok, 10700, Thailand
Kyiv, 03115, Ukraine
Kyiv, 03115, Ukraine
Kyiv, 03115, Ukraine
Lviv, 79044, Ukraine
Sheffield, South Yorkshire S10 2JF, United Kingdom