Study:
A PHASE III STUDY IN CHILDREN WITH UNTREATED ACUTE MYELOGENOUS LEUKEMIA (AML) OR MYELODYSPLASTIC SYNDROME (MDS)
Rationale:
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.
Purpose:
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.
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Leukemia
Myelodysplastic Syndromes |
Biological: aldesleukin
Biological: filgrastim
Drug: asparaginase
Drug: busulfan
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: etoposide
Drug: fludarabine phosphate
Drug: idarubicin
Drug: methotrexate
Drug: therapeutic hydrocortisone
Drug: thioguanine
Procedure: allogeneic bone marrow transplantation
Radiation: radiation therapy |
Phase 3 |
Verified by
Children`s Oncology Group
October, 2002
Sponsored by: Children`s Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00002798
Study Type: Interventional
Study Design: Allocation: Randomized, Primary Purpose: Treatment
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United States
Beverly J. Lange, MD., Study Chair