Busulfan, Cyclophosphamide, and Melphalan Followed by Allogeneic Hematopoietic Cell Transplantation in Patients With Hematological Malignancies
Subjects will be admitted to the bone marrow transplant unit and put in isolation to reduce
exposure to infectious agents.
Prior to transplantation, they will receive BUSULFAN via the central venous line, four times
a day for four days, CYCLOPHOSPHAMIDE via the central venous line once a day for two days,
and MELPHALAN via the central venous line for one day. Busulfan, cyclophosphamide, and
melphalan are given to destroy the subject's cancer. As well, these drugs will destroy
their immune system to help ensure the new stem cells take and grow after transplantation.
On the day of transplantation, umbilical cord blood from the donor will be transfused via
venous line. These new cells will replace the subject's bone marrow.
After transplantation, the subjects will receive Cyclosporin A and either MMF or MTX
Isolation will be continued until adequate numbers of cells are present in the blood to
fight infection. Subjects will be discharged from the hospital when medically ready. They
will be expected to return for follow-up to the blood and marrow transplant clinic at
specific dates as determined by physicians.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Probability of Long-term Disease-free Survival (DFS)
Number of participants with long-term disease free survival after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.
Margaret MacMillan, MD
Masonic Cancer Center, University of Minnesota
United States: Institutional Review Board
|Masonic Cancer Center, University of Minnesota||Minneapolis, Minnesota 55455|