Unrelated Bone Marrow Transplantation With Cyclophosphamide and Total Body Irradiation For Hematologic Malignancies and Bone Marrow Failure States
OBJECTIVES:
- Study the curative potential of high-dose cyclophosphamide and total-body irradiation
followed by rescue with bone marrow from volunteer HLA-matched donors in patients with
a variety of hematologic malignancies and bone marrow failure states.
- Study the toxic effects associated with matched unrelated bone marrow transplantation
in this patient population.
- Participate in collaborative research studies with the National Marrow Donor Program.
OUTLINE: All patients receive myeloablative therapy with high-dose cyclophosphamide and
total body irradiation over 4 days; patients with severe aplastic anemia also receive
antithymocyte globulin. Patients then undergo allogeneic bone marrow transplantation.
Filgrastim (G-CSF) is given after transplant to accelerate engraftment. Sargramostim
(GM-CSF) may be given in case of graft failure.
All patients receive graft-versus-host-disease (GVHD) prophylaxis with tacrolimus,
methotrexate, and gamma globulin. Established GVHD is treated with corticosteroids and, as
necessary, antithymocyte globulin.
Patients are followed at 100 days, 6 months, and 1 year after transplant, then annually
thereafter.
PROJECTED ACCRUAL: A total of 10 patients per year will be accrued for this study over 5
years.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Kenneth F. Mangan, MD, FACP
Study Chair
Fox Chase Cancer Center
United States: Federal Government
CDR0000064937
NCT00002809
August 1996
December 2003
Name | Location |
---|---|
Fox Chase-Temple Cancer Center | Philadelphia, Pennsylvania 19111-2442 |