Clinical trial · Interventional
Treatment of Children and Adolescents With Refractory or Relapsed Acute Myeloid Leukemia
A Randomized Phase III Study of the Treatment of Children and Adolescents With Refractory or Relapsed Acute Myeloid Leukemia
NCT00186966CI-TRIAL-00004649completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Etoposide, Thioguanine, Cyclophosphamide, Busulfan, Melphalan | Drug | — | UNRESOLVED |
| Fludarabine, Cytarabine, Liposomal daunorubicin (DaunoXome) | Drug | — | UNRESOLVED |
| Hematopoietic stem cell transplant | Procedure | — | UNRESOLVED |
| Total body irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- FLAG
- interventionNames
- Drug: Fludarabine, Cytarabine, Liposomal daunorubicin (DaunoXome)
- Drug: Etoposide, Thioguanine, Cyclophosphamide, Busulfan, Melphalan
- Procedure: Hematopoietic stem cell transplant
- Radiation: Total body irradiation
- type
- OTHER
- label
- FLAG and LP Dox
- interventionNames
- Drug: Fludarabine, Cytarabine, Liposomal daunorubicin (DaunoXome)
- Drug: Etoposide, Thioguanine, Cyclophosphamide, Busulfan, Melphalan
- Procedure: Hematopoietic stem cell transplant
- Radiation: Total body irradiation
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Children and adolescents less than eighteen years of age at start of chemotherapy. * Subject has one of the following: Primary refractory AML, first relapsed AML, second or subsequent relapsed AML and was not previously treated according to this particular protocol * Subjects with a combined relapse, or an isolated extramedullary relapse, or a bone marrow relapse are eligible, also for randomization. Exclusion Criteria: * Symptomatic cardiac dysfunction. * Inadequate performance score. * Any other organ dysfunction that will interfere with the administration of the therapy. * FAB type M3
References
Publications (1)
- RESULTKaspers 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.