Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024128
Status:
WITHDRAWN
Last Update Posted:
2016-02-03
First Post:
2001-09-13
Brief Title:
Peripheral Stem Cell Transplantation Followed By Infusion of White Blood Cells in Treating Patients With AIDS-Related Lymphoma
Sponsor:
AIDS Malignancy Consortium
Organization:
AIDS Malignancy Consortium
Study Overview
Official Title:
Delayed Donor Leukocyte Infusions in Patients Receiving Allogeneic PBSC Following Conditioning With Non-myeloablative Regimen for AIDS-Related Lymphoma NHL and HD
Status:
WITHDRAWN
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn prior to initiation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Donor peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy Sometimes the transplanted cells are rejected by the bodys normal tissues Treatment with donor white blood cells may prevent this from happening
PURPOSE Phase II trial to study the effectiveness of donor peripheral stem cell transplantation followed by infusions of donor white blood cells in treating patients who have AIDS-related lymphoma
PURPOSE Phase II trial to study the effectiveness of donor peripheral stem cell transplantation followed by infusions of donor white blood cells in treating patients who have AIDS-related lymphoma
Detailed Description:
OBJECTIVES
Determine the response rate of patients with AIDS-related lymphoma treated with allogeneic peripheral blood stem cell PBSC transplantation followed by delayed donor leukocyte infusion
Determine the complication rate of these patients treated with PBSC transplantation
Determine the immune dysfunction and recovery of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive cyclophosphamide IV over 60 minutes on days -5 to -3 Patients who have not received prior mediastinal radiotherapy receive thymic radiotherapy on day -1 Allogeneic peripheral blood stem cells are infused on day 0 Patients also receive anti-thymocyte globulin IV over 10-12 hours on days -1 1 3 and 5 and cyclosporine IV beginning on day -1 switching to oral when possible and tapering until day 35
In the absence of active acute graft-versus-host disease GVHD and at least 2 weeks after completion of cyclosporine patients receive an infusion of donor leukocytes on or before day 49 Patients may receive a second donor leukocyte infusion if there is evidence of persistent malignancy and no GVHD
Patients are followed through day 100 on days 120 180 270 and 365 and then every 6 months thereafter
PROJECTED ACCRUAL A total of 12-35 patients will be accrued for this study within 3-4 years
Determine the response rate of patients with AIDS-related lymphoma treated with allogeneic peripheral blood stem cell PBSC transplantation followed by delayed donor leukocyte infusion
Determine the complication rate of these patients treated with PBSC transplantation
Determine the immune dysfunction and recovery of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive cyclophosphamide IV over 60 minutes on days -5 to -3 Patients who have not received prior mediastinal radiotherapy receive thymic radiotherapy on day -1 Allogeneic peripheral blood stem cells are infused on day 0 Patients also receive anti-thymocyte globulin IV over 10-12 hours on days -1 1 3 and 5 and cyclosporine IV beginning on day -1 switching to oral when possible and tapering until day 35
In the absence of active acute graft-versus-host disease GVHD and at least 2 weeks after completion of cyclosporine patients receive an infusion of donor leukocytes on or before day 49 Patients may receive a second donor leukocyte infusion if there is evidence of persistent malignancy and no GVHD
Patients are followed through day 100 on days 120 180 270 and 365 and then every 6 months thereafter
PROJECTED ACCRUAL A total of 12-35 patients will be accrued for this study within 3-4 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 |
|---|---|---|---|
| CDR0000068894 | OTHER | NCI | None |