Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003196
Status:
COMPLETED
Last Update Posted:
2019-12-27
First Post:
1999-11-01
Brief Title:
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
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients bone marrow make stem cells red blood cells white blood cells and platelets Once the donated stem cells begin working the patients immune system may see the remaining cancer cells as not belonging in the patients body and destroy them Giving an infusion of the donors 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-00592 | REGISTRY | None | None |
| 122500A | None | None | None |
| 122500 | OTHER | None | None |
| P30CA015704 | NIH | Fred Hutchinson Cancer Research CenterUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP30CA015704 |