Study:
A Phase III Randomized Study Comparing Busulfan-Total Body Irradiation Versus Cyclophosphamide-Total Body Irradiation Preparative Regimen in Patients With Advanced Myelodysplastic Syndrome (MDS) or MDS-Related Acute Myeloid Leukemia (AML) Undergoing HLA-Identical Sibling Peripheral Blood Stem Cell Transplantation, (A BMT Study)
Rationale:
Peripheral stem cell transplantation may be able to replace immune cells that
were destroyed by chemotherapy or radiation therapy used to kill tumor cells. It is not yet
known if total-body irradiation plus peripheral stem cell transplantation is more effective
with busulfan or with cyclophosphamide for myelodysplastic syndrome or acute myeloid
leukemia.
Purpose:
Randomized phase III trial to compare the effectiveness of busulfan with that of
cyclophosphamide in patients undergoing total-body irradiation plus peripheral stem cell
transplantation for advanced myelodysplastic syndrome or related acute myeloid leukemia.
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Leukemia
Myelodysplastic Syndromes |
Drug: busulfan
Drug: cyclophosphamide
Drug: cyclosporine
Drug: methotrexate
Procedure: allogeneic bone marrow transplantation
Radiation: radiation therapy |
Phase 3 |
Verified by
Southwest Oncology Group
January, 2012
Sponsored by: Southwest Oncology Group
Information provided by: Southwest Oncology Group
ClinicalTrials.gov identifier: NCT00005866
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United States
Jeanne E. Anderson, MD., Study Chair