Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060424
Status:
COMPLETED
Last Update Posted:
2017-12-08
First Post:
2003-05-06
Brief Title:
Fludarabine Phosphate and Total-Body Irradiation Before Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Leukemia
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Allogeneic Hematopoietic Stem Cell Transplantation With Nonmyeloablative Conditioning for Patients With Chronic Lymphocytic Leukemia - A Multi-center Trial
Status:
COMPLETED
Status Verified Date:
2017-12
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 clinical trial studies how well giving fludarabine phosphate together with total-body irradiation TBI before donor peripheral blood stem cell transplant works in treating patients with chronic lymphocytic leukemia or small lymphocytic leukemia Giving low doses of chemotherapy such as fludarabine phosphate and TBI before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells Giving chemotherapy before or after peripheral blood stem cell transplant also stops 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 Sometimes the transplanted cells from a donor can also make an immune response against the bodys normal cells Giving cyclosporine and mycophenolate mofetil before and after the transplant may stop this from happening
Detailed Description:
PRIMARY OBJECTIVES
I To determine whether nonmyeloablative allogeneic hematopoietic stem cell transplantation HSCT from matched-related donors can improve the probability of survival 18 months after treatment for fludarabine fludarabine phosphate-refractory fludarabine phosphate cyclophosphamide and rituximab FCR-failed or del 17p chronic lymphocytic leukemia CLL beyond that observed in historical controls 30
SECONDARY OBJECTIVES
I To assess the rate of relapse with allogeneic HSCT using nonmyeloablative conditioning for patients with fludarabine-refractory FCR-failed or del 17p CLL compared with historical data on autologous HSCT
II To estimate the incidence of grade 2-4 acute graft-versus-host disease GVHD and chronic GVHD in patients with CLL treated with low-dose TBI fludarabine peripheral blood stem cell PBSC infusion and immunosuppression with cyclosporine and mycophenolate mofetil
III To characterize the rate and types of infections with this regimen
IV To estimate the rate of transplant-related mortality in the first 200 days
OUTLINE
NONMYELOABLATIVE CONDITIONING Patients receive fludarabine phosphate intravenously IV on days -4 to -2 and TBI on day 0
TRANSPLANT Patients undergo allogeneic peripheral blood stem cell transplant on day 0
GVHD PROPHYLAXIS Patients receive cyclosporine orally PO every 12 hours on days -3 to 180 with taper beginning on day 56 and mycophenolate mofetil PO every 12 hours on days 0-27
After completion of study treatment patients are followed up at 12 and 18 months and then annually for 5 years
I To determine whether nonmyeloablative allogeneic hematopoietic stem cell transplantation HSCT from matched-related donors can improve the probability of survival 18 months after treatment for fludarabine fludarabine phosphate-refractory fludarabine phosphate cyclophosphamide and rituximab FCR-failed or del 17p chronic lymphocytic leukemia CLL beyond that observed in historical controls 30
SECONDARY OBJECTIVES
I To assess the rate of relapse with allogeneic HSCT using nonmyeloablative conditioning for patients with fludarabine-refractory FCR-failed or del 17p CLL compared with historical data on autologous HSCT
II To estimate the incidence of grade 2-4 acute graft-versus-host disease GVHD and chronic GVHD in patients with CLL treated with low-dose TBI fludarabine peripheral blood stem cell PBSC infusion and immunosuppression with cyclosporine and mycophenolate mofetil
III To characterize the rate and types of infections with this regimen
IV To estimate the rate of transplant-related mortality in the first 200 days
OUTLINE
NONMYELOABLATIVE CONDITIONING Patients receive fludarabine phosphate intravenously IV on days -4 to -2 and TBI on day 0
TRANSPLANT Patients undergo allogeneic peripheral blood stem cell transplant on day 0
GVHD PROPHYLAXIS Patients receive cyclosporine orally PO every 12 hours on days -3 to 180 with taper beginning on day 56 and mycophenolate mofetil PO every 12 hours on days 0-27
After completion of study treatment patients are followed up at 12 and 18 months and then annually 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-2010-01276 | REGISTRY | None | None |
| NCI-2011-01116 | None | None | None |
| 171100 | OTHER | None | None |
| P30CA015704 | NIH | Fred Hutchinson Cancer Research CenterUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP30CA015704 |