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Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML
Not Recruiting
Trial ID: NCT00574873
Purpose
Two-arm, randomized, open-label trial designed to evaluate the efficacy and safety of
bosutinib alone compared to imatinib alone in subjects newly diagnosed with chronic phase
Chronic Myelogenous Leukemia (CML). The primary endpoint is cytogenetic response rate at one
year.
Official Title
A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF BOSUTINIB VERSUS IMATINIB IN SUBJECTS WITH NEWLY DIAGNOSED CHRONIC PHASE PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOGENOUS LEUKEMIA
Stanford Investigator(s)
Caroline Berube
Clinical Associate Professor, Medicine - Hematology
Jason Gotlib
Professor of Medicine (Hematology)
Eligibility
Inclusion Criteria:
- Cytogenetic diagnosis of chronic phase Ph+ CML diagnosed less than 6 months.
- Diagnosis of CML chronic phase confirmed.
- Adequate hepatic and renal function.
- Able to take oral tablets.
Exclusion Criteria:
- Exclusions include Philadelphia negative CML.
- Prior anti-leukemia treatment.
- Prior stem cell transplant.
Intervention(s):
drug: Bosutinib
drug: imatinib
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061