Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005801
Status:
COMPLETED
Last Update Posted:
2013-11-18
First Post:
2000-06-02
Brief Title:
Total-Body Irradiation Plus Stem Cell Transplantation And White Blood Cell Infusion in Treating Older Patients With Acute Myeloid Leukemia
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
A Phase II Study of Allografting to Establish Mixed or Full Donor Chimerism as Consolidative Immunotherapy for Older Patients With AML in Complete Remission Using Low Dose TBI PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil
Status:
COMPLETED
Status Verified Date:
2001-09
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:
RATIONALE Radiation therapy uses high-energy x-rays to damage tumor cells Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by radiation therapy used to kill tumor cells Infusions of donor white blood cells may decrease the bodys rejection of the transplanted peripheral stem cells
PURPOSE Phase II trial to study the effectiveness of combining radiation therapy peripheral stem cell transplantation and donor white blood cell infusions in treating older patients who have acute myeloid leukemia
PURPOSE Phase II trial to study the effectiveness of combining radiation therapy peripheral stem cell transplantation and donor white blood cell infusions in treating older patients who have acute myeloid leukemia
Detailed Description:
OBJECTIVES I Determine whether mixed or full donor chimerism can be safely established in older patients with acute myeloid leukemia AML treated with nonmyeloablative conditioning comprised of low dose total body irradiation followed by allogeneic peripheral blood stem cell transplantation followed by unrelated donor lymphocyte infusion DLI II Determine whether mixed chimerism can be safely converted to full donor chimerism in patients treated with DLI III Determine the potential efficacy of this regimen in AML patients who are in first remission
OUTLINE Conditioning Patients undergo low dose total body irradiation followed by infusion of allogeneic peripheral blood stem cells PBSC on day 0 Donor lymphocyte infusions Nonmobilized donor lymphocytes are harvested from the same HLA identical related donor on day 95 after PBSC transplantation Eligible patients with mixed chimerism and no graft versus host disease GVHD receive the first donor lymphocyte infusion DLI on the same day that donor lymphocytes are collected Patients who continue to have mixed chimerism and no GVHD receive the second DLI at a higher dose level on day 65 after the first DLI Patients are followed weekly until day 90 and then monthly thereafter
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 2 years
OUTLINE Conditioning Patients undergo low dose total body irradiation followed by infusion of allogeneic peripheral blood stem cells PBSC on day 0 Donor lymphocyte infusions Nonmobilized donor lymphocytes are harvested from the same HLA identical related donor on day 95 after PBSC transplantation Eligible patients with mixed chimerism and no graft versus host disease GVHD receive the first donor lymphocyte infusion DLI on the same day that donor lymphocytes are collected Patients who continue to have mixed chimerism and no GVHD receive the second DLI at a higher dose level on day 65 after the first DLI Patients are followed weekly until day 90 and then monthly thereafter
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 2 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-G00-1778 | None | None | None |
| UCHSC-00119 | None | None | None |
| FHCRC-140600 | None | None | None |