drugset / Trial / NCT00186966
Treatment of Children and Adolescents With Refractory or Relapsed Acute Myeloid Leukemia
Phase 3
Completed
394 enrolled
Dutch Childhood Oncology Group
International BFM Study Group · collabSt. Jude Children's Research Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2002-03
- Primary completion
- 2009-04
- Completion
- 2010-09
Publications
- Results Kaspers J, Zimmermann M, Fleischhack G, Tamminga R, Gibson B, Armendariz H, Dworzak M, Ha S, Hovi L, Maschan A, Philippe N, Razzouk B, Rizzari C, Smisek P, Smith O, Stark B, Will A, Creutzig U. Relapsed Acute Myeloid Leukemia in Children and Adolescents: Interim Report of the International Randomised Phase III Study Relapsed AML 2001/01. 2006 ASH Annual Meeting Abstracts 108: 2013.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daunorubicin | Small molecule | — | — |
| Background | Busulfan | Small molecule | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Cytarabine | Small molecule | — | — |
| Background | Etoposide | Small molecule | — | — |
| Background | Fludarabine | Small molecule | — | — |
| Background | Melphalan | Small molecule | — | — |
| Background | Thioguanine | Small molecule | — | — |