Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075478
Status:
COMPLETED
Last Update Posted:
2017-05-15
First Post:
2004-01-09
Brief Title:
Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Multi-center Phase III Study Comparing Nonmyeloablative Conditioning With TBI Versus FludarabineTBI for HLA-matched Related Hematopoietic Cell Transplantation for Treatment of Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2017-04
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 randomized phase III trial is studying total-body irradiation TBI and fludarabine phosphate to see how it works compared with TBI alone followed by donor stem cell transplant in treating patients with hematologic cancer Giving low doses of chemotherapy such as fludarabine phosphate and radiation therapy before a donor stem cell transplant helps stop the growth of cancer cells It also stops the patients immune system from rejecting the donors stem cells The donated stem cells may replace the patients immune system 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 after transplant may stop this from happening It is not yet known whether TBI followed by donor stem cell transplant is more effective with or without fludarabine phosphate in treating hematologic cancer
Detailed Description:
PRIMARY OBJECTIVES
I To compare overall survival at 3 years after conditioning with 200 cGy TBI alone vs fludarabine fludarabine phosphate200 cGy TBI in heavily pretreated patients with hematologic malignancies at lowmoderate risk for graft rejection
SECONDARY OBJECTIVES
I To compare the non-relapse mortality 1-year after conditioning in patients who received TBI alone vs fludarabineTBI
II To compare the incidences of graft rejection in patients who received TBI alone vs fludarabineTBI
III To compare the incidences of grades II-IV acute graft-versus-host disease GVHD and chronic extensive GVHD
IV To compare rates of disease progression andor relapse-related mortality
V To compare the immune reconstitution and the risks of infections
OUTLINE
NONMYELOABLATIVE CONDITIONING REGIMEN Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive fludarabine phosphate intravenously IV on days -4 to -2 Patients then undergo low-dose TBI on day 0
ARM II Patients undergo low-dose TBI on day 0
ALLOGENEIC PERIPHERAL BLOOD STEM CELL TRANSPLANTATION PBSCT After TBI patients undergo PBSCT on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine orally PO twice daily BID on days -3 to 56 in the absence of GVHD Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180 Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks Patients also receive mycophenolate mofetil MMF PO BID on days 0-28 in the absence of GVHD If treatment for GVHD is required before day 28 MMF is continued until a steroid taper begins
Patients are followed up periodically for 15 years and then annually for 5 years post-transplantation
I To compare overall survival at 3 years after conditioning with 200 cGy TBI alone vs fludarabine fludarabine phosphate200 cGy TBI in heavily pretreated patients with hematologic malignancies at lowmoderate risk for graft rejection
SECONDARY OBJECTIVES
I To compare the non-relapse mortality 1-year after conditioning in patients who received TBI alone vs fludarabineTBI
II To compare the incidences of graft rejection in patients who received TBI alone vs fludarabineTBI
III To compare the incidences of grades II-IV acute graft-versus-host disease GVHD and chronic extensive GVHD
IV To compare rates of disease progression andor relapse-related mortality
V To compare the immune reconstitution and the risks of infections
OUTLINE
NONMYELOABLATIVE CONDITIONING REGIMEN Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive fludarabine phosphate intravenously IV on days -4 to -2 Patients then undergo low-dose TBI on day 0
ARM II Patients undergo low-dose TBI on day 0
ALLOGENEIC PERIPHERAL BLOOD STEM CELL TRANSPLANTATION PBSCT After TBI patients undergo PBSCT on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine orally PO twice daily BID on days -3 to 56 in the absence of GVHD Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180 Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks Patients also receive mycophenolate mofetil MMF PO BID on days 0-28 in the absence of GVHD If treatment for GVHD is required before day 28 MMF is continued until a steroid taper begins
Patients are followed up periodically for 15 years and then annually for 5 years post-transplantation
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-2009-01532 | REGISTRY | None | None |
| 181300 | OTHER | None | None |
| P30CA015704 | NIH | None | None |
| P01CA078902 | NIH | Fred Hutchinson Cancer Research CenterUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP01CA078902 |