Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00245037
Status:
COMPLETED
Last Update Posted:
2017-09-27
First Post:
2005-10-25
Brief Title:
Busulfan Fludarabine and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
A Phase III Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplant for the Treatment of Patients With Hematologic Malignancies Using Busulfan Fludarabine and Total Body Irradiation
Status:
COMPLETED
Status Verified Date:
2017-09
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:
Bu Flu TBI
Brief Summary:
RATIONALE Giving low doses of chemotherapy such as fludarabine and busulfan before a donor peripheral blood 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 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 and mycophenolate mofetil after the transplant may stop this from happening
PURPOSE This phase III trial is studying the side effects of giving busulfan and fludarabine together with total-body irradiation and to see how well they work in treating patients who are undergoing a donor stem cell transplant for hematologic cancer
PURPOSE This phase III trial is studying the side effects of giving busulfan and fludarabine together with total-body irradiation and to see how well they work in treating patients who are undergoing a donor stem cell transplant for hematologic cancer
Detailed Description:
OBJECTIVES
Primary
To assess safety and toxicity of the addition of busulfan added to an established fludarabine and low-dose total-body irradiation TBI conditioning regimen for non-myeloablative allogeneic transplantation in patients with hematologic malignancies Phase I
To assess the non-relapse mortality 1-year after conditioning with busulfan and fludarabineTBI in patients with hematologic malignancies at moderate to high risk for graft rejection andor relapse of underlying disease Phase II
Secondary
To assess overall survival 1-year survival Phase II
To assess the incidence of graft rejection Phase II
To assess the incidence of grade II-IV acute graft-vs-host disease GVHD and chronic extensive GVHD Phase II
To assess rates of disease progression andor relapse-related mortality Phase II
To determine non-hematologic grade III-IV organ specific toxicity Phase II
OUTLINE
Nonmyeloablative-conditioning regimen Patients receive busulfan IV on day -5 and fludarabine IV over 30 minutes on days -4 to -2 Patients undergo total body irradiation on day 0
Allogeneic peripheral blood stem cell transplantation PBSC Patients undergo donor PBSC infusion on day 0
Graft-versus-host disease prophylaxis Patients receive oral cyclosporine twice daily on days -3 to 56 followed by a taper to day 180 Patients with a related stem cell donor receive oral mycophenolate mofetil twice daily on days 0-28 Patients with an unrelated stem cell donor receive oral mycophenolate mofetil 3 times daily on days 0-28 followed by a taper twice daily to day 56 Patients with evidence of relapse or persistent disease may also receive up to 3 donor lymphocyte infusions
PROJECTED ACCRUAL A total of 225 patients will be accrued for this study 25 patients accrued into the Phase I and 200 patients into Phase II
Primary
To assess safety and toxicity of the addition of busulfan added to an established fludarabine and low-dose total-body irradiation TBI conditioning regimen for non-myeloablative allogeneic transplantation in patients with hematologic malignancies Phase I
To assess the non-relapse mortality 1-year after conditioning with busulfan and fludarabineTBI in patients with hematologic malignancies at moderate to high risk for graft rejection andor relapse of underlying disease Phase II
Secondary
To assess overall survival 1-year survival Phase II
To assess the incidence of graft rejection Phase II
To assess the incidence of grade II-IV acute graft-vs-host disease GVHD and chronic extensive GVHD Phase II
To assess rates of disease progression andor relapse-related mortality Phase II
To determine non-hematologic grade III-IV organ specific toxicity Phase II
OUTLINE
Nonmyeloablative-conditioning regimen Patients receive busulfan IV on day -5 and fludarabine IV over 30 minutes on days -4 to -2 Patients undergo total body irradiation on day 0
Allogeneic peripheral blood stem cell transplantation PBSC Patients undergo donor PBSC infusion on day 0
Graft-versus-host disease prophylaxis Patients receive oral cyclosporine twice daily on days -3 to 56 followed by a taper to day 180 Patients with a related stem cell donor receive oral mycophenolate mofetil twice daily on days 0-28 Patients with an unrelated stem cell donor receive oral mycophenolate mofetil 3 times daily on days 0-28 followed by a taper twice daily to day 56 Patients with evidence of relapse or persistent disease may also receive up to 3 donor lymphocyte infusions
PROJECTED ACCRUAL A total of 225 patients will be accrued for this study 25 patients accrued into the Phase I and 200 patients into Phase II
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 |
|---|---|---|---|
| OHSU-210 | OTHER | OHSU IRB | httpsreporternihgovquickSearchP30CA016058 |
| P30CA016058 | NIH | None | None |
| OHSU-HEM-05011-L | OTHER | None | None |