Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003145
Status:
COMPLETED
Last Update Posted:
2020-01-10
First Post:
1999-11-01
Brief Title:
Fludarabine Phosphate Low-Dose Total-Body Irradiation and Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Older Patients With Chronic Myeloid Leukemia
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Induction of Mixed Hematopoietic Chimerism Using Fludarabine Low Dose TBI PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil to be Followed by Donor Lymphocyte Infusion In Patients With Chronic Myeloid Leukemia in Chronic and Accelerated Phases A Multi-center Study
Status:
COMPLETED
Status Verified Date:
2020-01
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 clinical trial studies fludarabine phosphate low-dose total-body irradiation and peripheral blood stem cell transplant followed by donor lymphocyte infusion in treating older patients with chronic myeloid leukemia Giving chemotherapy and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells It may also stop the patients immune system from rejecting the donors stem cells When the 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 Sometimes the transplanted cells from a donor can make an immune response against the bodys normal cells Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening 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 called graft-versus-tumor effect Giving an infusion of the donors white blood cells donor lymphocyte infusion may boost this effect
Detailed Description:
PRIMARY OBJECTIVES
I To determine if mixed hematopoietic chimerism can be safely established using a non-myeloablative conditioning regimen in patients 65 years of age with chronic myeloid leukemia CML in chronic or accelerated phase who have human leukocyte antigen HLA identical related donors
II To determine if mixed chimerism established with non-myeloablative conditioning regimens can be converted to full donor hematopoietic chimerism by infusions of donor lymphocytes DLI and thereby produce an immunologic cure of the malignancy
OUTLINE
CONDITIONING REGIMEN Patients receive fludarabine phosphate intravenously IV on days -4 to -2 and undergo low-dose total-body irradiation TBI on day 0
TRANSPLANTATION Patients undergo allogeneic peripheral blood stem cell transplantation PBSCT on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine orally PO twice daily BID or IV BID or thrice daily TID on days -3 to 56 with taper to day 77 or 180 and mycophenolate mofetil PO or IV BID on days 0-27
DLI At least 2 weeks after completion of immunosuppression patients with 5 donor cluster of differentiation CD3 T cells and no evidence of graft-versus-host disease GVHD receive donor lymphocytes IV over 30 minutes Patients may receive up to 3 DLIs at increasing cell doses in the absence of GVHD
After completion of study treatment patients are followed up periodically for 5 years
I To determine if mixed hematopoietic chimerism can be safely established using a non-myeloablative conditioning regimen in patients 65 years of age with chronic myeloid leukemia CML in chronic or accelerated phase who have human leukocyte antigen HLA identical related donors
II To determine if mixed chimerism established with non-myeloablative conditioning regimens can be converted to full donor hematopoietic chimerism by infusions of donor lymphocytes DLI and thereby produce an immunologic cure of the malignancy
OUTLINE
CONDITIONING REGIMEN Patients receive fludarabine phosphate intravenously IV on days -4 to -2 and undergo low-dose total-body irradiation TBI on day 0
TRANSPLANTATION Patients undergo allogeneic peripheral blood stem cell transplantation PBSCT on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine orally PO twice daily BID or IV BID or thrice daily TID on days -3 to 56 with taper to day 77 or 180 and mycophenolate mofetil PO or IV BID on days 0-27
DLI At least 2 weeks after completion of immunosuppression patients with 5 donor cluster of differentiation CD3 T cells and no evidence of graft-versus-host disease GVHD receive donor lymphocytes IV over 30 minutes Patients may receive up to 3 DLIs at increasing cell doses in the absence of GVHD
After completion of study treatment patients are followed up periodically for 5 years
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 |
|---|---|---|---|
| P30CA015704 | NIH | Fred Hutchinson Cancer Research CenterUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP30CA015704 |
| NCI-2012-00579 | REGISTRY | None | None |
| 120900 | OTHER | None | None |