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A Randomized Phase III Study of the Treatment of Children and Adolescents With Refractory or Relapsed Acute Myeloid Leukemia
This is an international multicenter open label randomized phase III trial in children with relapsed and refractory acute myeloid leukemia (AML) such a disease. The main purpose of this study is to determine the efficacy and toxicity of liposomal daunorubicin when added to fludarabine, ara-C and G-CSF(FLAG) in children with relapsed and refractory AML.
Details
| Lead sponsor | Dutch Childhood Oncology Group |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 394 |
| Start date | 2002-03 |
| Completion | 2010-09 |
Conditions
- Acute Myeloid Leukemia
Interventions
- Fludarabine, Cytarabine, Liposomal daunorubicin (DaunoXome)
- Etoposide, Thioguanine, Cyclophosphamide, Busulfan, Melphalan
- Hematopoietic stem cell transplant
- Total body irradiation
Primary outcomes
- Response Rate — 8-9 years
Countries
United States