Lymphoma Clinical Trial
Official title:
Evaluation of Allogeneic Marrow Transplants Depleted of T-Cells by CD34+ Selection in Patients Undergoing Transplantation With an Unrelated Matched or 1 Antigen Mismatched Donor or a 1 Antigen Mismatched Related Donor
RATIONALE: Bone marrow that has been treated to remove certain white blood cells may be able
to replace immune cells that were destroyed by chemotherapy or radiation therapy, and may
reduce the chance of developing graft-versus-host disease following bone marrow
transplantation.
PURPOSE: Phase IV trial to study the incidence of graft-versus-host disease in patients who
have hematologic cancer and who are undergoing bone marrow transplantation from a donor.
OBJECTIVES: I. Evaluate the incidence of acute graft versus host disease in patients
undergoing transplantation with an unrelated or related matched or mismatched antigen donor.
II. Evaluate the rapidity of engraftment and CD4 count recovery post-transplantation in this
patient population.
OUTLINE: Patients receive total body irradiation (TBI) three or two times a day on days -8 to
-5. Following TBI, patients receive thiotepa IV over 4 hours daily on days -4 and -3 plus
cyclophosphamide IV over 1 hour daily on days -2 and -1. Antithymocyte globulin is
administered by IV over at least 4 hours on days -4 to -1. Patients undergo an allogenic bone
marrow transplantation on day 0. Bone marrow is harvested from patient's donor, depleted of
T-cells, and infused. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 4.
PROJECTED ACCRUAL: Approximately 26-45 patients will be accrued for this study within 3-4
years.
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