Allogeneic Bone Marrow Transplantation for Marrow Failure States
OBJECTIVES: I. Determine the graft failure rate and overall survival of patients with severe
aplastic anemia after receiving an allogeneic bone marrow transplant. II. Determine the
efficacy of high dose cyclophosphamide and antithymocyte globulin as conditioning regimen
for a second bone marrow transplant in patients who reject their first graft. III. Determine
the efficacy of methylprednisolone and anti-CD3 monoclonal antibody as a conditioning
regimen for a second bone marrow transplant in patients who reject their first graft and are
poor candidates for cyclophosphamide and antithymocyte globulin.
OUTLINE: Patients with graft failure with the following organ function and performance
status are assigned to arm I: Performance status: Karnofsky 60-100% Pulmonary: FEV1 and DLCO
at least 50% Cardiac: Left ventricular ejection fraction at least 45% Hepatic: None to mild
venoocclusive disease Patients with graft failure with the following organ function and
performance status are assigned to arm II: Performance status: Karnofsky 20-50% Pulmonary:
FEV1 or DLCO less than 50% Cardiac: Left ventricular ejection fraction less than 45%
Hepatic: Moderate to severe venoocclusive disease Patients with aplastic anemia are assigned
to arm I. Arm I: Patients receive cyclophosphamide IV over 1 hour on days -5 to -2,
antithymocyte globulin IV over 8 hours on days -5 to -3, and bone marrow transplant on day
0. Arm II: Patients receive methylprednisolone IV twice a day on days -5 to 62; monoclonal
antibody OKT3 IV on days -1 to 24; bone marrow transplant on day 0; oral cyclosporine twice
a day starting day 20; and filgrastim (G-CSF) subcutaneously once a day starting day -5
until blood counts recover. Patients are followed once a week for 3 months and then monthly
for one year.
PROJECTED ACCRUAL: A total of 40 patients (20 with aplastic anemia and 20 with graft
failure) will be accrued for this study.
Interventional
Primary Purpose: Treatment
Steven C. Goldstein, MD
Study Chair
H. Lee Moffitt Cancer Center and Research Institute
United States: Federal Government
MCC-11309
NCT00005852
June 1996
July 2007
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