A phase III randomized, open-label, multi-center study of nilotinib versus imatinib in adult patients with philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP) who have suboptimal cytogenetic response (CyR) ib unatubub
- Conditions
- Chronic myeloid leukemia (CML)10024324
- Registration Number
- NL-OMON31183
- Lead Sponsor
- Medisch Spectrum Twente
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
Adult patients with suboptimal cytogenetic response to a dose of 400 mg imatinib (first line therapy) defined as:
* 6-12 months of treatment and have 36-95% Ph+ metaphases or
* 12-18 months of treatment and have 1-35% Ph+ metaphases;EOG 0, 1, or 2;Patients must meet the following laboratory criteria:
Total bilirubin <1.5 X ULN
SGOT and SGPT <2.5 X ULN
Creatinine <1.5 X ULN
Serum potassium, phosphorus, magnesium and calcium >LLN or correctable with supplements prior to first dose of study drug.;Written informed consent.
Previously documented T315I mutations;Achieved prior PCyR or CCyR on imatinib and lost that response prior to entering the study;Prior treatment with > 400 mg imatinib;Previous treatment with any other tyrosine kinase inhibitor except imatinib;Impaired cardiac function
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the CCyR rate at 12 months of nilotinib compared to imatinib in<br /><br>adult patients with Ph+ CML in CP who have a suboptimal cytogenetic response on<br /><br>imatinib.</p><br>
- Secondary Outcome Measures
Name Time Method