Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005799
Status:
COMPLETED
Last Update Posted:
2019-09-10
First Post:
2000-06-02
Brief Title:
Fludarabine Phosphate Low-Dose Total Body Irradiation and Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies or Kidney Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Low-Dose TBI and Fludarabine Followed by Unrelated Donor Stem Cell Transplantation for Patients With Hematologic Malignancies and Renal Cell Carcinoma - A Multi-center Trial
Status:
COMPLETED
Status Verified Date:
2019-09
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 donor stem cell transplant in treating patients with hematologic malignancies or kidney cancer Giving chemotherapy drugs such as fludarabine phosphate and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells It may also stop the patients immune system from rejecting the donors stem cells The donated stem cells may replace the patients immune cells and help destroy any remaining cancer cells graft-versus-tumor effect Giving an infusion of the donors T cells donor lymphocyte infusion after the transplant may help increase this effect Sometimes the transplanted cells from a donor can also make an immune response against the bodys normal cells Giving cyclosporine before the transplant and cyclosporine and mycophenolate mofetil after the transplant may stop this from happening
Detailed Description:
PRIMARY OBJECTIVES
I To determine whether stable allogeneic engraftment from unrelated hematopoietic stem cell donors can be safely established using a non-myeloablative conditioning regimen in patients with hematologic malignancies and renal cell carcinoma
SECONDARY OBJECTIVES
I To evaluate whether donor lymphocyte infusion DLI can be safely used in patients with mixed or full donor chimerism to eliminate persistent or progressive disease
OUTLINE
CONDITIONING REGIMEN Patients receive fludarabine phosphate intravenously IV on days -4 to -2 Patients also undergo low-dose total-body irradiation TBI on day 0
TRANSPLANTATION Patients undergo allogeneic peripheral blood stem cell PBSC or bone marrow transplantation on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine orally PO twice daily BID on days -3 to 100 with taper to day 177 and mycophenolate mofetil PO BID on days 0-40 with taper to day 96 Patients with mixed chimerism persistent or progressive disease and no evidence of graft-versus-host disease and who have been off immunosuppression for at least 2 weeks undergo DLI over 30 minutes DLI may be repeated every 65 days for up to 3 doses
After completion of study treatment patients are follow-up periodically for 5 years
I To determine whether stable allogeneic engraftment from unrelated hematopoietic stem cell donors can be safely established using a non-myeloablative conditioning regimen in patients with hematologic malignancies and renal cell carcinoma
SECONDARY OBJECTIVES
I To evaluate whether donor lymphocyte infusion DLI can be safely used in patients with mixed or full donor chimerism to eliminate persistent or progressive disease
OUTLINE
CONDITIONING REGIMEN Patients receive fludarabine phosphate intravenously IV on days -4 to -2 Patients also undergo low-dose total-body irradiation TBI on day 0
TRANSPLANTATION Patients undergo allogeneic peripheral blood stem cell PBSC or bone marrow transplantation on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine orally PO twice daily BID on days -3 to 100 with taper to day 177 and mycophenolate mofetil PO BID on days 0-40 with taper to day 96 Patients with mixed chimerism persistent or progressive disease and no evidence of graft-versus-host disease and who have been off immunosuppression for at least 2 weeks undergo DLI over 30 minutes DLI may be repeated every 65 days for up to 3 doses
After completion of study treatment patients are follow-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 |
|---|---|---|---|
| NCI-2012-00667 | REGISTRY | None | None |
| 146300 | OTHER | None | None |
| P01CA018029 | NIH | None | None |
| P30CA015704 | NIH | Fred Hutchinson Cancer Research CenterUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP30CA015704 |