Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101140
Status:
WITHDRAWN
Last Update Posted:
2017-10-19
First Post:
2005-01-07
Brief Title:
Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia in Remission
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Study of Haploidentical Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With High-Risk Acute Myeloid Leukemia in First Remission
Status:
WITHDRAWN
Status Verified Date:
2017-10
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 A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy Sometimes the transplanted cells from a donor can make an immune response against the bodys normal cells Giving total-body irradiation together with fludarabine thiotepa and antithymocyte globulin before transplant may stop this from happening
PURPOSE This phase II trial is studying how well a donor stem cell transplant works in treating patients with acute myeloid leukemia in remission
PURPOSE This phase II trial is studying how well a donor stem cell transplant works in treating patients with acute myeloid leukemia in remission
Detailed Description:
OBJECTIVES
Primary
Determine the safety and antileukemia activity of haploidentical allogeneic peripheral blood stem cell transplantation in patients with high-risk acute myeloid leukemia in first remission
Secondary
Determine the early treatment-related mortality before day 100 of patients treated with this regimen
Determine the incidence of acute graft-versus-host disease in patients treated with this regimen
Determine the incidence of graft failure in patients treated with this regimen
Correlate a mismatch in the expression of the natural killer cell inhibitory receptors CD158a and CD158b with engraftment and disease recurrence in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive a preparative regimen comprising total-body irradiation twice on day -8 fludarabine IV over 30 minutes on days -7 to -3 thiotepa IV over 2 hours twice on day -7 and antithymocyte globulin IV over 4-6 hours on days -5 to -2 Patients undergo haploidentical allogeneic peripheral blood stem cell transplantation on day 0
Patients are followed at day 100 at least monthly for 2 years and then periodically for 3 years
PROJECTED ACCRUAL A total of 44 patients will be accrued for this study within 22 years
Primary
Determine the safety and antileukemia activity of haploidentical allogeneic peripheral blood stem cell transplantation in patients with high-risk acute myeloid leukemia in first remission
Secondary
Determine the early treatment-related mortality before day 100 of patients treated with this regimen
Determine the incidence of acute graft-versus-host disease in patients treated with this regimen
Determine the incidence of graft failure in patients treated with this regimen
Correlate a mismatch in the expression of the natural killer cell inhibitory receptors CD158a and CD158b with engraftment and disease recurrence in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive a preparative regimen comprising total-body irradiation twice on day -8 fludarabine IV over 30 minutes on days -7 to -3 thiotepa IV over 2 hours twice on day -7 and antithymocyte globulin IV over 4-6 hours on days -5 to -2 Patients undergo haploidentical allogeneic peripheral blood stem cell transplantation on day 0
Patients are followed at day 100 at least monthly for 2 years and then periodically for 3 years
PROJECTED ACCRUAL A total of 44 patients will be accrued for this study within 22 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ECOG-E1903 | None | None | None |