Clinical Trials Directory

Trials / Completed

CompletedNCT00003196

Low-Dose Total Body Irradiation and Donor Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Patients With Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma

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.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
63 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
50 Years – 65 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGchemotherapyUndergo cytoreductive chemotherapy
RADIATIONtotal-body irradiationUndergo TBI
PROCEDUREperipheral blood stem cell transplantationUndergo allogeneic PBSC transplant
DRUGcyclosporineGiven IV or PO
DRUGmycophenolate mofetilGiven PO
PROCEDUREallogeneic hematopoietic stem cell transplantationUndergo allogeneic PBSC transplant
BIOLOGICALtherapeutic allogeneic lymphocytesUndergo DLI

Timeline

Start date
1997-09-01
Primary completion
2002-04-01
Completion
2002-04-01
First posted
2004-07-19
Last updated
2019-12-27

Locations

5 sites across 3 countries: United States, Germany, Italy

Source: ClinicalTrials.gov record NCT00003196. Inclusion in this directory is not an endorsement.