drugset / Trial / NCT00002798

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

NCT00002798

Phase 3 Completed 880 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

Randomized phase III trial to compare the effectiveness of different chemotherapy regimens with or without bone marrow transplantation in treating children who have acute myelogenous leukemia or myelodysplastic syndrome. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which treatment regimen is more effective for acute myelogenous leukemia or myelodysplastic syndrome

Timeline

Start
1996-08
Primary completion
2006-09
Completion

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule Intravenous
Subject Daunorubicin Small molecule Intravenous
Subject Fludarabine Small molecule Intravenous
Subject Idarubicin Small molecule Intravenous
Subject aldesleukin Protein / enzyme biologic Intravenous
Subject asparaginase Protein / enzyme biologic
Background Busulfan Small molecule Oral
Background Cyclophosphamide Other / unclassified Intravenous
Background Dexamethasone Small molecule Oral
Background Etoposide Small molecule Intravenous
Background Hydrocortisone Other / unclassified Intrathecal
Background Methotrexate Small molecule Intrathecal
Background Thioguanine Small molecule Oral
Background filgrastim Protein / enzyme biologic Subcutaneous