Finding studies
Finding studies
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Lead
Fred Hutchinson Cancer Center
With
PRIMARY OBJECTIVES: I. To determine whether stable allogeneic engraftment from related and unrelated human leukocyte antigen (HLA)-mismatched stem cell donors can be safely established using a non-myeloablative conditioning regimen plus escalating doses of the anti-CD52 monoclonal antibody (mAb) Campath (alemtuzumab) in patients with hematologic malignancies. SECONDARY OBJECTIVES: I. Evaluate the risk of occurrence of acute and chronic graft-vs-host disease (GVHD). II. Evaluate the risk/incidence of infections. III. Determine whether engraftment can be maintained with a single dose fludarabine, donor lymphocyte infusion (DLI) and continued MMF/CSP. IV. Evaluate the risk for disease progression and relapse. OUTLINE: This is a dose-escalation study of alemtuzumab. CONDITIONING REGIMEN: Patients receive alemtuzumab intravenously (IV) over 2 hours on days -8 to -5 and fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT): Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or orally (PO) twice daily (BID) on days -3 to 180 with taper to day 365 and MMF PO thrice daily (TID) on days 0-100 with taper to day 156. After completion of study treatment, patients are followed up periodically.
Age
0–74
Sex
ALL
Healthy volunteers
Not accepted
