Allogeneic Hematopoietic Cell Transplantation for Patients With Busulfex-based Regimen
Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
Summary
RATIONALE: Giving chemotherapy, such as fludarabine and busulfan, before a donor peripheral
stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop
the patient's immune system from rejecting the donor's stem cells. When the healthy stem
cells from a donor are infused into the patient they may help the patient's bone marrow make
stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted
cells from a donor can make an immune response against the body's normal cells. Giving a
monoclonal antibody, alemtuzumab, before the transplant and tacrolimus after the transplant
may stop this from happening.
PURPOSE: The phase I portion of this trial identified the maximum tolerated dose of busulfan
after treating 40 patients on a dose-escalation scheme. We are now treating an additional 26
patients on the phase II portion of the trial at a Pharmacokinetic (PK)-directed dose of
total area under curve (AUC) 6912 micrometer (uM)-min/24 hours. We transitioned to the Phase
II portion of the study in October 2009.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborators:
National Cancer Institute (NCI) Otsuka America Pharmaceutical