Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus donor bone marrow transplantation in treating patients who have hematologic cancer.
|Leukemia Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes||Drug: busulfan Drug: cyclophosphamide Drug: methylprednisolone Procedure: allogeneic bone marrow transplantation Procedure: in vitro-treated bone marrow transplantation||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Matched Unrelated and Haploidentical Bone Marrow Transplantation for Hematologic Malignancies|
|Study Start Date:||April 1998|
|Study Completion Date:||September 2001|
|Primary Completion Date:||September 2001 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the 1-year survival rate of patients with hematologic malignancies after treatment with HLA-matched allogeneic bone marrow transplantation after high-dose chemotherapy.
OUTLINE: Patients receive oral busulfan four times a day on days -8 to -5, cyclophosphamide IV over 1 hour on days -4 to -1, and methylprednisolone IV over 1 hour every 12 hours on days -2 to 0. CD34+ stem cell augmented donor bone marrow is infused on day 0. Methylprednisolone is administered IV over 1 hour on days 5-16, and then tapered. Patients are followed every 6 months for 1 year and then annually thereafter.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003960
|United States, Maryland|
|Johns Hopkins Oncology Center|
|Baltimore, Maryland, United States, 21231|
|United States, South Carolina|
|Center for Cancer Treatment and Research|
|Columbia, South Carolina, United States, 29203|
|Study Chair:||Paul V. O'Donnell, MD, PhD||Fred Hutchinson Cancer Research Center|