EWOG - MDS 98 Myelodysplastic Syndromes in ChildhoodProspective Study of the Diagnosis and Treatmentof Myelodysplastic Syndromes (MDS) in Childhood - EWOG-MDS 98
- Conditions
- Myelodysplastic syndrome, unspecifiedD46.9
- Registration Number
- DRKS00000001
- Lead Sponsor
- niversitätsklinikum Freiburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 714
Inclusion Criteria
All children and adolescents with MDS under the age of 19 diagnosed between July 1998 and June 2002 are registered as study patients.
Exclusion Criteria
- Children with Down syndrome
- Children with the following cytogenetic or molecular abnormalities:
t(8;21)(q22;q22) [AML1/ETO fusion gene]
t(15;17)(q22;q12) [PML/RAR´´ rearrangement]
inv(16)(p13q22) [CBF$/MYH11rearrangement]
- Children with the typical clinical and cytogenetic features of AML FAB M7 who present with < 30% blasts in the BM and PB
- Concomitant illness precluding therapy according to protocol
- No informed consent by the patient or legal guardian
- Morphological diagnosis could not be confirmed
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - To evaluate the frequency of the different FAB subtypes by a standardized approach<br>- To evaluate the frequency of cytogenetic and molecular abnormalities
- Secondary Outcome Measures
Name Time Method - To improve survival for children and adolescents with primary MDS over that reported in the<br>literature<br>- To assess the rate of complete remission (CR) and the event-free survival (EFS) in children<br>with primary MDS treated according to AML therapy<br>- To evaluate the relapse rate, morbidity and mortality in children with primary MDS treated by<br>SCT<br>- To identify different subsets of patients with primary MDS benefiting from SCT or AML-type<br>therapy