AML-BFM 2012: clinical trial for the treatment of acute myeloid leukemia in children and adolescents
Phase 3
- Conditions
- Pediatric acute myeloid leukemiaCancerAcute myeloblastic leukaemia
- Registration Number
- ISRCTN78830591
- Lead Sponsor
- Medical School of Hannover (MHH) (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped
- Sex
- All
- Target Recruitment
- 448
Inclusion Criteria
1. Diagnosis of an AML (It. WHO classification 2008)
2. Ages 0 to 18 years, either sex
3. Informed Consent of the guardians
Exclusion Criteria
1. Existing illnesses / syndromes which exclude treatment
2. Patients with trisomy 21 and ML-DS and/or transient myeloproliferative syndrome (referred to TMD-prevention study or the ML-DS 2006 study)
3. Refusal of treatment/missing consent to treatment or protocol
4. Pregnancy/breastfeeding
5. Patients of child-bearing age who decline a pregnancy test
6. Previous-therapy with cytostatic medicines of more than 14 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Event-Free Survival (EFS) of the randomized patients. The EFS will be calculated from day 0 (date of diagnosis) to the first event (non-response, relapse, second malignancy or death for any reason) or the last follow-up.<br> 2. Disease-Free Survival (DFS). The DFS will be calculated from date of randomization to the first event (relapse, second malignancy or death for any reason) or the last follow-up.<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Overall survival<br> 2. Detection of molecular relapse<br> 3. Response kinetics for minimal residual disease.<br> The minimal Rest Disease (MRD) will be monitored at the start of each treatment element in the peripheral blood (PB) and bone marrow samples (BM). In all patients with molecular or cytogenetic markers for MDR (Fusion genes AML1/ETO, CBL/MYH11, MLL/X, OTT/MAL; Mutations: NPM1, FLT3-ITD, WT1, c-kit, GATA1, CEPBa, RAS)<br> 4. Relapse incidence<br> 5. Quality of life through toxicity monitoring<br> 6. Assessment of safety: Serious Adverse Events (SAE), long-term follow-up of late adverse effects<br>