Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005606
Status:
COMPLETED
Last Update Posted:
2012-06-06
First Post:
2000-05-02
Brief Title:
Peripheral Blood Lymphocyte Therapy to Prevent Lymphoproliferative Disorders Caused by Epstein-Barr Virus in Patients Who Have Undergone Transplantation
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Adoptive Immunotherapy of Epstein Barr Virus Induced Lymhoproliferative Disease A Comparison of Allogeneic and Autologous Lymphocyte Responses ex Vivo and Use of Highly Selected Reactive Cells as an Alternative to Chemotherapy in Vivo
Status:
COMPLETED
Status Verified Date:
2012-05
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 Peripheral blood lymphocyte therapy may be effective in the treatment and prevention of Epstein-Barr virus infection following transplantation
PURPOSE Phase II trial to study the effectiveness of peripheral blood lymphocyte therapy in treating and preventing lymphoproliferative disorders in patients who have Epstein-Barr virus infection following transplantation
PURPOSE Phase II trial to study the effectiveness of peripheral blood lymphocyte therapy in treating and preventing lymphoproliferative disorders in patients who have Epstein-Barr virus infection following transplantation
Detailed Description:
OBJECTIVES
Compare the efficacy of Epstein Barr virus EBV reactive autologous and allogeneic lymphocyte clones ex vivo in targeting EBV immortalized lymphoblasts in patients undergoing a solid organ transplant or T cell depleted bone marrow transplant
Determine the efficacy of these regimens as treatment and prophylaxis in those patients who develop EBV viremia or EBV induced lymphoproliferative disease
OUTLINE Autologous and allogeneic Epstein Barr virus EBV reactive lymphocytes are isolated from patients and siblings and tested in vitro for cytotoxic activity
Patients who develop EBV viremia or EBV related lymphoproliferative disease after transplant receive autologous Epstein Barr virus EBV reactive lymphocytes IV over 20 minutes Patients receive allogeneic EBV reactive lymphocytes if autologous lymphocytes fail to control EBV proliferation or when sufficient autologous reactive lymphocytes cannot be isolated Treatment repeats every 4 weeks in the presence of EBV viremia or lymphoproliferative disease After 5 patients have received therapy without unacceptable toxicity patients may receive lymphocytes as prophylactic therapy
Patients are followed at 4 weeks 8 weeks 6 months and 12 months
PROJECTED ACCRUAL A total of 10-20 patients will be accrued for this study
Compare the efficacy of Epstein Barr virus EBV reactive autologous and allogeneic lymphocyte clones ex vivo in targeting EBV immortalized lymphoblasts in patients undergoing a solid organ transplant or T cell depleted bone marrow transplant
Determine the efficacy of these regimens as treatment and prophylaxis in those patients who develop EBV viremia or EBV induced lymphoproliferative disease
OUTLINE Autologous and allogeneic Epstein Barr virus EBV reactive lymphocytes are isolated from patients and siblings and tested in vitro for cytotoxic activity
Patients who develop EBV viremia or EBV related lymphoproliferative disease after transplant receive autologous Epstein Barr virus EBV reactive lymphocytes IV over 20 minutes Patients receive allogeneic EBV reactive lymphocytes if autologous lymphocytes fail to control EBV proliferation or when sufficient autologous reactive lymphocytes cannot be isolated Treatment repeats every 4 weeks in the presence of EBV viremia or lymphoproliferative disease After 5 patients have received therapy without unacceptable toxicity patients may receive lymphocytes as prophylactic therapy
Patients are followed at 4 weeks 8 weeks 6 months and 12 months
PROJECTED ACCRUAL A total of 10-20 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 |
|---|---|---|---|
| NCI-G00-1739 | None | None | None |
| NU-98H1 | None | None | None |