Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
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.
This pilot clinical trial studies low-dose total body irradiation and donor peripheral blood stem cell transplant followed by donor lymphocyte infusion in treatment patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, or multiple myeloma. Giving total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them. Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.
PRIMARY OBJECTIVES:
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).
OUTLINE:
CYTOREDUCTION: If necessary, patients with advanced malignancies undergo cytoreductive
chemotherapy to reduce tumor size at discretion of primary physician and study investigators.
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.
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