Evaluation of Allogeneic Peripheral Blood Stem Cell Transplants From a Related Donor Without Graft-Versus-Host Prophylaxis in Patients With High Risk of Relapse
OBJECTIVES: I. Evaluate the use of donor peripheral blood stem cells without
graft-versus-host disease prophylaxis to maximize the probability of graft-versus-tumor
effect in patients with hematologic malignancies refractory to standard chemotherapy and
unlikely to be cured with high dose chemotherapy and radiotherapy.
OUTLINE: Prior to peripheral blood stem cell transplant, patients undergo preparative
cytoreduction. Patients receive total body irradiation (TBI) beginning on day -5.
Radiotherapy is administered in 9 doses over 3 days (3 doses per day for 3 days). Male
patients with acute lymphocytic leukemia receive an additional dose of radiation to the
testicles. Patients who are ineligible for TBI due to prior radiotherapy receive 2 doses of
melphalan IV on day -3. All patients receive cyclophosphamide IV over 1 hour on days -2 and
-1. Anti-thymocyte globulin is also administered IV over 6 hours on days -2 and -1.
Approximately 24-36 hours after the last dose of cyclophosphamide, peripheral blood stem
cells obtained from the HLA matched related donor are infused into the patient. Patients do
not receive graft-versus-host disease prophylaxis after transplant; however, all other forms
of supportive care are provided. Patients are followed for 1 year.
PROJECTED ACCRUAL: A maximum of 42 patients will be accrued for this study.
Primary Purpose: Treatment
Barry R. Meisenberg, MD
University of Maryland Greenebaum Cancer Center
United States: Federal Government
|Marlene & Stewart Greenebaum Cancer Center, University of Maryland
|Baltimore, Maryland 21201