Prospective study of quantitative molecular minimal residual disease (MRD) monitoring in pediatric acute myeloid leukemia (AML).
- Conditions
- AM
- Registration Number
- NL-OMON24742
- Lead Sponsor
- Dept of Pediatric OncologyErasmus MC-Sophia Children's HospitalPOB 20603000 CB RotterdamNetherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
1. AML, established according to the WHO-classification, and treated according to a collaborative group AML protocol;
2. One of the following genetic aberrations documented at diagnosis:
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
1. Down syndrome leukemia;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Whether all newly diagnosed pediatric AML patients with specific genetic subtypes (for which a sensitive quantatative MRD marker is available) with rising MRD-values (RT-qPCR) will eventually develop relapse.
- Secondary Outcome Measures
Name Time Method 1. To study the kinetics of rising RT-qPCR levels, and the time to overt relapse, and relate this to the various genetic abnormalities, with the aim to assess the most appropriate time-interval between PB-sampling for the various genetic subcategories in pediatric AML;<br /><br>2. To study MRD levels prior to SCT in patients who have relapsed and who have received standard chemotherapy re-induction for haematological relapse;<br /><br>3. To set-up a network of laboratories to implement serial MRD-assessment;<br /><br>4. To implement quality control between laboratories participating in this network.