Allogeneic Peripheral Blood Stem Cell Transplantation Using a Non-Myeloablative Preparative Regimen for Patients With Hematologic Malignancies
OBJECTIVES: I. Determine the effect of nonmyeloablative chemotherapy followed by allogeneic
peripheral blood stem cell transplantation on hematopoietic recovery in patients with
hematologic malignancies. II. Determine the toxicities of this regimen in these patients.
III. Determine the frequency of mixed hematopoietic chimerism in these patients after this
therapy. IV. Determine the efficacy and toxicity of donor leukocyte infusions at relapse in
these patients. V. Determine the response rates and survival of these patients after this
therapy. VI. Determine the immune reconstitution of patients undergoing this therapy.
OUTLINE: Patients receive fludarabine IV over 30 minutes on days -9 to -5, cyclophosphamide
IV over 1 hour on day -5, and antithymocyte globulin IV over 10 hours on days -5 to -2.
Allogeneic peripheral blood stem cells are infused on day 0. Patients who achieve complete
remission (CR) and then relapse or patients who achieve less than a CR before day 60 receive
donor leukocyte infusions (DLI) over 30 minutes. DLI are repeated as necessary for
persistent disease. Patients are followed at 1, 3, and 6 months, then at 1 and 2 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Hematopoetic recovery and toxicities of non-myeloablative allogenic stem cell transplantation Hematopoetic recovery and toxicities of non-myeloablative allogenic stem cell transplantation
5 years
Yes
Todd M. Zimmerman, MD
Study Chair
University of Chicago
United States: Federal Government
9581
NCT00004145
November 1998
June 2006
Name | Location |
|---|---|
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
