Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053014
Status:
TERMINATED
Last Update Posted:
2015-03-25
First Post:
2003-01-27
Brief Title:
S0125 Chemotherapy Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
S0125 A Phase II Study Of Chimerism-Mediated Immunotherapy CMI Using Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation In Older Patients With Acute Myeloid Leukemia AML In First Complete Remission A BMT Study
Status:
TERMINATED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy Sometimes the transplanted cells can make an immune response against the bodys normal tissues Cyclosporine and mycophenolate mofetil may prevent this from happening
PURPOSE Phase II trial to study the effectiveness of chemotherapy and total-body irradiation followed by donor peripheral stem cell transplantation cyclosporine and mycophenolate mofetil in treating older patients who have acute myeloid leukemia
PURPOSE Phase II trial to study the effectiveness of chemotherapy and total-body irradiation followed by donor peripheral stem cell transplantation cyclosporine and mycophenolate mofetil in treating older patients who have acute myeloid leukemia
Detailed Description:
Primary objective
Determine whether allogeneic peripheral blood stem cell transplantation with pre-conditioning low dose total body irradiation and fludarabine followed by cyclosporine and mycophenolate mofetil when given to elderly patients with acute myeloid leukemia in first complete remission is sufficiently efficacious in terms of survival 1 year after transplantation to warrant a phase III investigation
Secondary objective
Determine the frequency and severity of toxic effects of this regimen in these patients
Other objectives as funding permits
Determine whether chimerism patterns in bone marrow and blood after transplantation are associated with relapse andor graft-versus-host disease GVHD in these patients
Determine whether cytogenic immunophenotypic and molecular biologic features detected in pre- and post-transplantation specimens are related to transplant outcomes and risk of relapse in these patients
OUTLINE This is an open-label study
Conditioning regimen Patients receive fludarabine IV over 1 hour on days -4 to -2 Patients also undergo total body irradiation on day 0
Peripheral blood stem cell infusion PBSC Patients receive unmodified filgrastim transplantation G-CSF-mobilized donor PBSC on day 0
Post-transplantation immunosuppression Patients receive oral cyclosporine on days -3 to 35 followed by a taper until day 180 Patients also receive oral mycophenolate mofetil on day 0 to 27 without tapering
Donor lymphocyte infusions DLI Patients with relapsed disease receive DLI IV over 30 minutes for up to 2 infusions
Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for 3 years
PROJECTED ACCRUAL A total of 25-51 patients will be accrued for this study
Determine whether allogeneic peripheral blood stem cell transplantation with pre-conditioning low dose total body irradiation and fludarabine followed by cyclosporine and mycophenolate mofetil when given to elderly patients with acute myeloid leukemia in first complete remission is sufficiently efficacious in terms of survival 1 year after transplantation to warrant a phase III investigation
Secondary objective
Determine the frequency and severity of toxic effects of this regimen in these patients
Other objectives as funding permits
Determine whether chimerism patterns in bone marrow and blood after transplantation are associated with relapse andor graft-versus-host disease GVHD in these patients
Determine whether cytogenic immunophenotypic and molecular biologic features detected in pre- and post-transplantation specimens are related to transplant outcomes and risk of relapse in these patients
OUTLINE This is an open-label study
Conditioning regimen Patients receive fludarabine IV over 1 hour on days -4 to -2 Patients also undergo total body irradiation on day 0
Peripheral blood stem cell infusion PBSC Patients receive unmodified filgrastim transplantation G-CSF-mobilized donor PBSC on day 0
Post-transplantation immunosuppression Patients receive oral cyclosporine on days -3 to 35 followed by a taper until day 180 Patients also receive oral mycophenolate mofetil on day 0 to 27 without tapering
Donor lymphocyte infusions DLI Patients with relapsed disease receive DLI IV over 30 minutes for up to 2 infusions
Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for 3 years
PROJECTED ACCRUAL A total of 25-51 patients will be accrued for this study
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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0125 | OTHER | None | None |