Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066417
Status:
TERMINATED
Last Update Posted:
2013-05-01
First Post:
2003-08-06
Brief Title:
Peripheral Stem Cell Transplant in Treating Patients With High-Risk Leukemia
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Pilot Study Of T-Cell-Depleted Peripheral Blood Stem Cell Transplantation From Partially Matched Related Donors For Patients With High-Risk Leukemia
Status:
TERMINATED
Status Verified Date:
2006-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial was withdrawn for drug availability issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Giving chemotherapy and total-body irradiation before a donor peripheral stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patients immune system from rejecting the donors stem cells When the stem cells from a related donor that do not exactly match the patients blood are infused into the patient they may help the patients bone marrow make stem cells red blood cells white blood cells and platelets
PURPOSE This phase II trial is studying how well peripheral stem cell transplant works in treating patients with high-risk leukemia
PURPOSE This phase II trial is studying how well peripheral stem cell transplant works in treating patients with high-risk leukemia
Detailed Description:
OBJECTIVES
Determine the safety of a preparative regimen comprising total body irradiation cyclophosphamide thiotepa and fludarabine but without anti-thymocyte globulin in patients with high-risk leukemia treated with peripheral blood stem cell transplantation from partially matched related donors
Determine the incidence of graft failure acute graft-versus-host disease GVHD and treatment-related mortality in patients treated with this regimen
Determine rates of chronic GVHD and relapse in patients treated with this regimen
Determine disease-free and overall survival in patients treated with this regimen
OUTLINE This is a pilot study
Patients receive a preparative regimen comprising total lymphoid irradiation once daily on days -13 to -11 cyclophosphamide IV over 1 hour on days -8 and -7 thiotepa IV over 4 hours every 12 hours on day -6 fludarabine IV over 30 minutes on days -5 to -1 and total body irradiation once on day -1 Patients also receive cyclosporine IV over 12 hours on days -8 to -1 and methylprednisolone IV twice daily on days -3 and -2 Patients receive CD34-enriched T-cell-depleted allogeneic stem cell infusion on day 0
Patients with disease progression or uncontrolled infection but without grade II or greater graft-versus-host disease may receive up to 3 donor lymphocyte infusions at least 4 weeks apart until disease regression
Patients are followed at least weekly until day 100 and then at 6 12 18 24 36 and 48 months
PROJECTED ACCRUAL A total of 20-51 patients will be accrued for this study
Determine the safety of a preparative regimen comprising total body irradiation cyclophosphamide thiotepa and fludarabine but without anti-thymocyte globulin in patients with high-risk leukemia treated with peripheral blood stem cell transplantation from partially matched related donors
Determine the incidence of graft failure acute graft-versus-host disease GVHD and treatment-related mortality in patients treated with this regimen
Determine rates of chronic GVHD and relapse in patients treated with this regimen
Determine disease-free and overall survival in patients treated with this regimen
OUTLINE This is a pilot study
Patients receive a preparative regimen comprising total lymphoid irradiation once daily on days -13 to -11 cyclophosphamide IV over 1 hour on days -8 and -7 thiotepa IV over 4 hours every 12 hours on day -6 fludarabine IV over 30 minutes on days -5 to -1 and total body irradiation once on day -1 Patients also receive cyclosporine IV over 12 hours on days -8 to -1 and methylprednisolone IV twice daily on days -3 and -2 Patients receive CD34-enriched T-cell-depleted allogeneic stem cell infusion on day 0
Patients with disease progression or uncontrolled infection but without grade II or greater graft-versus-host disease may receive up to 3 donor lymphocyte infusions at least 4 weeks apart until disease regression
Patients are followed at least weekly until day 100 and then at 6 12 18 24 36 and 48 months
PROJECTED ACCRUAL A total of 20-51 patients will be accrued for this study
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 |
|---|---|---|---|
| NHLBI-03-H-0209 | None | None | None |