# Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

> **NCT00002798** · PHASE3 · COMPLETED · sponsor: **National Cancer Institute (NCI)** · enrollment: 880 (actual)

## Conditions studied

- Childhood Acute Erythroleukemia (M6)
- Childhood Acute Megakaryocytic Leukemia (M7)
- Childhood Acute Monoblastic Leukemia (M5a)
- Childhood Acute Monocytic Leukemia (M5b)
- Childhood Acute Myeloblastic Leukemia With Maturation (M2)
- Childhood Acute Myeloblastic Leukemia Without Maturation (M1)
- Childhood Acute Myelomonocytic Leukemia (M4)
- Childhood Myelodysplastic Syndromes
- Chronic Myelomonocytic Leukemia
- de Novo Myelodysplastic Syndromes
- Refractory Anemia
- Refractory Anemia With Excess Blasts
- Refractory Anemia With Excess Blasts in Transformation
- Refractory Anemia With Ringed Sideroblasts
- Secondary Myelodysplastic Syndromes
- Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies

## Interventions

- **DRUG:** asparaginase
- **DRUG:** daunorubicin hydrochloride
- **DRUG:** fludarabine phosphate
- **DRUG:** therapeutic hydrocortisone
- **PROCEDURE:** allogeneic bone marrow transplantation
- **RADIATION:** 3-dimensional conformal radiation therapy
- **BIOLOGICAL:** filgrastim
- **DRUG:** cytarabine
- **DRUG:** idarubicin
- **DRUG:** dexamethasone
- **DRUG:** thioguanine
- **DRUG:** etoposide
- **DRUG:** methotrexate
- **DRUG:** cyclophosphamide
- **BIOLOGICAL:** aldesleukin
- **DRUG:** busulfan

## Key facts

- **NCT ID:** NCT00002798
- **Lead sponsor:** National Cancer Institute (NCI)
- **Sponsor class:** NIH
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 1996-08
- **Primary completion:** 2006-09
- **Final completion:** —
- **Target enrollment:** 880 (ACTUAL)
- **Last updated:** 2013-01-16


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00002798

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00002798, "Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myelogenous Leukemia or Myelodysplastic Syndrome". Retrieved via AI Analytics 2026-06-09 from https://api.ai-analytics.org/clinical/NCT00002798. Licensed CC0.

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