An international collaborative study to discontinue Imatinib/Glivec® in pediatric CML patients with sustained complete molecular response
Phase 4
Completed
- Conditions
- chronic myeloid leukemia10024324
- Registration Number
- NL-OMON39021
- Lead Sponsor
- Stichting Kinderoncologie Nederland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
Pediatric CML patients treated with Imatinib having achieved and maintained complete molecular remission for at least 2 years.
Informed consent needs to be signed.
Exclusion Criteria
Non-CML patients, or CML patients with complete cytogenetic reponse but with a moderate molecular response.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints:<br /><br>Molecular relapse free survival at 6 and 24 months.<br /><br>Duration of complete molecular remission after stopping Imatinib.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints:<br /><br>Prognostic studies.<br /><br>Overall survival and survival without progression.<br /><br>Efficacy of restarting Imatinib in a period of 6 months after molecular<br /><br>relapse.</p><br>