An international collaborative study to discontinue Imatinib/Glivec® in pediatric CML patients with sustained complete molecular response(STOPIMAPED)
- Conditions
- Chronic Myeloid Leukemia pediatric patients treated with Imatinib having achieved and maintained complete molecular remission for at least 2 years.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-006239-44-NL
- Lead Sponsor
- Dutch Childhood Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 12
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Non-CML patients, or CML patients with complete cytogenetic reponse but with a moderate molecular response.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To estimate the percentage of quantitative RT-PCR negative pediatric CML patients in which Imatinib discontinuation result in sustained complete molecular remission<br>;Secondary Objective: To determine whether restarting of Imatinib or another tyrosine kinase inhibitor in case of molecular relapse results in a molecular remission again.<br>;Primary end point(s): Molecular relapse free survival at 6 and 24 months. <br>Duration of complete molecular remission after stopping Imatinib.<br>;Timepoint(s) of evaluation of this end point: 4 yrs international protocol of the IBFM CML study group.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Prognostic studies:<br>Overall survival and survival without progression.<br>Efficacy of restarting Imatinib in a period of 6 months after molecular relapse. <br>;Timepoint(s) of evaluation of this end point: 4 yrs international protocol of the IBFM CML study group.