An international collaborative study to discontinue Imatinib/Glivec® in pediatric CML patients with sustained complete molecular response (STOPIMAPED).
Not yet recruiting
- Conditions
- CMLchildrenstop Imatinib/Glivec®complete molecular response
- Registration Number
- NL-OMON23324
- Lead Sponsor
- SKION/DCOG (Stichting Kinderoncologie Nederland)Leyweg 2992545CJ Den Haag
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
1. Pediatric CML patients treated with Imatinib having achieved and maintained complete molecular remission for at least 2 years;
2. 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 1. Molecular relapse free survival at 6 and 24 months;<br /><br>2. Duration of complete molecular remission after stopping Imatinib.
- Secondary Outcome Measures
Name Time Method 1. Prognostic studies;<br /><br>2. Overall survival and survival without progression;<br /><br>3. Efficacy of restarting Imatinib in a period of 6 months after molecular relapse.<br>