T-cell Depletion In Unrelated Donor Marrow Transplantation
OBJECTIVES: I. Compare unrelated donor bone marrow transplantation using T-cell-depleted
marrow versus unmodified marrow in adults and children with leukemia. II. Evaluate 2-year
leukemia-free survival, primary and secondary graft failure, graft-versus-host disease,
infection, and relapse in these patients. III. Assess the quality of life associated with
T-cell-depleted versus unmodified, unrelated donor transplantation.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center.
Patients receive myeloablative therapy according to diagnosis: those with acute lymphocytic
leukemia and lymphoblastic lymphoma are treated with total body irradiation (TBI), with a
testicular and chest wall boost as appropriate, followed by cyclophosphamide (CTX); patients
with undifferentiated or biphenotypic leukemia or with acute or chronic myelocytic leukemia
are treated with CTX followed by TBI. Patients are then randomly assigned to receive
non-T-cell-depleted, unrelated marrow versus T-cell-depleted, unrelated marrow. The modified
marrow is depleted of T-lymphocytes by counterflow elutriation and positively selected for
CD34 cells. Graft-versus-host disease (GVHD) prophylaxis with cyclosporine and methotrexate
is given to the unmodified marrow group. Patients who receive modified marrow are given
antithymocyte globulin (or methylprednisolone) for graft rejection prophylaxis before
transplantation and cyclosporine and methylprednisolone for GVHD prophylaxis after
transplantation.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
John E. Wagner, MD
Study Chair
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
1996LS142
NCT00006451
April 1996
November 2000
Name | Location |
---|---|
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |