Imatinib Versus Imatinib and Peg-Interferon in Patients With Ph+ CML and Complete Cytogenetic Response After Imatinib Therapy
Phase 3
- Conditions
- Leukemia, Myeloid, Philadelphia-Positive
- Registration Number
- NCT00297570
- Lead Sponsor
- Sheba Medical Center
- Brief Summary
The study is controlled and randomized in Philadelphia-positive chronic myeloid leukemia (Ph+ CML) patients with complete cytogenetic response after more than one year of imatinib therapy. The aim is to explore a possible benefit in the addition of peg-interferon (Peg-IFN) to imatinib, in terms of the rate of achievement, molecular remission, and response duration.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
- Ph+ CML patients in complete cytogenetic response (CCR) after more than 1 year of imatinib therapy.
Exclusion Criteria
- Patients in imatinib study
- Patients with a history of intolerability to interferon.
- Patients with less than CCR or less than one year of imatinib therapy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Hematology, Sheba Medical Center
🇮🇱Tel-Hashomer, Israel