Induction Of Mixed Hematopoietic Chimerism In Older Patients With B-Cell Malignancies and in Selected Other Diseases, Using Low Dose TBI , PBSC Infusion And Post-Transplant Immunosuppression With Cyclosporine And Mycophenolate Mofetil to be Followed by Donor Lymphocyte Infusion: A Pilot Study.
I. To determine whether mixed hematopoietic chimerism can be safely established using a
non-myeloablative conditioning regimen in patients with non-Hodgkin lymphoma (NHL), chronic
lymphocytic leukemia (CLL) and multiple myeloma.
II. To determine whether mixed chimerism, established with non- myeloablative conditioning
regimens, can be safely converted to full donor hematopoietic chimerism by infusions of
donor lymphocytes (DLI).
CYTOREDUCTION: If necessary, patients with advanced malignancies undergo cytoreductive
chemotherapy to reduce tumor size at discretion of primary physician and study
CONDITIONING REGIMEN: Patients undergo low-dose total-body irradiation followed by
allogeneic peripheral blood stem cell (PBSC) transplant on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine intravenously (IV) twice daily (BID) on
days -1 to 0 and then orally (PO) BID on days 1-35 with taper to day 56. Patients also
receive mycophenolate mofetil PO BID on days 0-27.
POST-TRANSPLANT DLI: Patients with mixed chimerism on day 56 and no evidence of
graft-vs-host disease (GVHD) undergo DLI over 30 minutes on day 65 and may receive up to 3
additional infusions in the absence of GVHD and disease progression or persistence. Patients
who have not achieved mixed chimerism at day 56 undergo DLI if complete response is not
obtained after a 2 month monitoring period.
After completion of study treatment, patients are followed up at 4, 6, 12, 18, and 24 months
and then annually thereafter.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of GVHD, myelosuppression, and infections
At the conclusion of the study, all unexpected toxicities will be summarized and reported.
Up to 5 years
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
|Stanford University||Stanford, California 94305|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|City of Hope Medical Center||Duarte, California 91010|