TRIAL Relapsed AML 2001/01.
Completed
- Conditions
- Refractory or relapsed acute myeloid leukemia in children and adolescents.
- Registration Number
- NL-OMON20351
- Lead Sponsor
- Dutch Childhood Oncology GroupDen HaagThe Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 400
Inclusion Criteria
1. Primary refractory AML;
Exclusion Criteria
1. Symptomatic cardiac dysfunction (CTC grade 3 or 4), and/or a fractional shortening at echocardiography below 29%;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of BM blasts >20% after course I, determined 4-6 weeks after the start.
- Secondary Outcome Measures
Name Time Method 1. Toxicity, focussing on but not limited to bone marrow aplasia, mucosal toxicity and cardiotoxicity;<br><br />2. Efficacy as determined by day 14 BM blasts, time to PB clearance of blasts, CR rate after 2 course of chemotherapy, % of patients that underwent SCT, overall survival, event-free survival and disease-free survival;<br><br />3. Clinical and cell biological features, and overall outcome of the entire cohort of patients with relapsed AML that has been registered in the time period of patient accrual (also including patients that were not treated according to this protocol).