Status:
UNKNOWN
Therapy-Optimization Trial for the Treatment of Acute Myeloid Leukemias (AML) in Children and Adolescents
Lead Sponsor:
University Hospital Muenster
Collaborating Sponsors:
Deutsche Krebshilfe e.V., Bonn (Germany)
Conditions:
Myeloid Leukemia
Eligibility:
All Genders
1-18 years
Phase:
PHASE2
PHASE3
Brief Summary
Due to progressive therapy intensification in the four consecutive studies AML-BFM 78, 83, 93 and 98, prognosis for children with acute myeloid leukemia (AML) has improved steadily. In spite of the in...
Detailed Description
During the last decade, prognosis in acute myelogenous leukemia (AML) in childhood has improved considerably, but still 30% of the children experience a relapse of disease and further 10% fail to resp...
Eligibility Criteria
Inclusion
- Age from \>0 to \</=18 years
- De novo AML, including children with Down syndrome, primary myelosarcomas or acute mixed lineage leukemia/biphenotypic leukemia (predominantly myeloid)
- Admission to one of the member hospitals in Germany participating in the study AML-BFM 2004
Exclusion
- Children with pre-existing syndromes (except Down syndrome)
- AML as secondary malignancy
- Accompanying diseases which do not allow therapy according to the protocol
- Pre-treatment for more than 14 days with another intensive induction therapy
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT00111345
Start Date
March 1 2004
End Date
March 1 2017
Last Update
May 23 2012
Active Locations (1)
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1
University Children's Hospital Muenster, Department of Paediatric Haematology and Oncology
Münster, North Rhine-Westphalia, Germany, D-48129