Conditions: Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive
Keywords: Leukemia Myelogenous Chronic BCR-ABL Positive Bosutinib Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Philadelphia Chromosome Neoplasms by Histologic Type Bone Marrow Diseases Hematologic Diseases Translocation, Genetic Pathologic Processes Imatinib Therapeutic Uses Pharmacologic Actions Molecular Mechanisms of Pharmacological Action
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 536
Healthy volunteers: no

Brief summary:
Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study.

Detailed description:
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.

Arms:
arm 1: Bosutinib, 400 mg, oral administration once a day arm 2: Imatinib, 400 mg, oral administration once a day

Interventions: intervention 1: Bosutinib intervention 2: Imatinib
Intervention descriptions: intervention 1: Bosutinib (Bosulif®) is an orally bioavailable, potent, multi-targeted, dual Src-Abl tyrosine kinase inhibitor (TKI) that has been approved for the treatment of adult patients with Philadelphia positive (Ph+) chronic phase (CP), accelerated phase (AP) and blast phase (BP) chronic myelogenous leukemia (CML) previously treated with other TKI inhibitor therapy.\[1\] This study will investigate the use of bosutinib as first-line treatment for patients with Ph+ CP CML. intervention 2: Imatinib mesylate (referred to in this protocol as imatinib) is an inhibitor of the BCR-ABL kinase and been the standard first-line therapy for patients with chronic-phase CML. Imatinib was granted approval by the European Commission in November 2001 and by the FDA in December 2002 for the treatment of newly diagnosed patients with CP Ph+ CML based on results from the IRIS trial.

Imatinib is considered the standard of care for both first-line and later line settings, and consequently is an appropriate active comparator.

Protocol document: