Status:
COMPLETED
Comparison of Consolidation Strategies for Pediatric Patients With Acute Myeloid Leukemia
Lead Sponsor:
Grupo Argentino de Tratamiento de la Leucemia Aguda
Conditions:
AML
Pediatric AML
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE3
Brief Summary
GATLA 8-AML´07 trial is an multicenter phase III dose-optimization trial for the treatment of acute myeloid leukemias in children and adolescents. Patients are treated with a combination of intensive ...
Detailed Description
All patients in the trial, whether standard risk (SR) or high risk (HR), receive 2 Induction courses: AIE and HAM and then are randomized to continue with the consolidation phase: a conventional conso...
Eligibility Criteria
Inclusion
- De novo AML
- FAB M0-M7
- Primary myelosarcomas or acute mixed lineage leukemia / biphenotypic leukemia (predominantly myeloid).
- Written informed consent from patients, parents, or guardians was obtained at study entry in accordance with the Declaration of Helsinki
Exclusion
- AML as secondary malignancy
- Children with Down's syndrome
- Accompanying diseases which do not allow therapy according to the protocol
- Pre-treatment for more than 14 days with another intensive induction therapy
- Patients with APL
- Patients with myelodysplasia
- Patients with blast crisis of Chronic Myeloid Leukemia
- Patients who die before starting treatment
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2015
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT06211452
Start Date
August 1 2007
End Date
December 21 2015
Last Update
January 18 2024
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