allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes
autologous Epstein-Barr virus-specific cytotoxic T lymphocytes
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00005606
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
NU 98H1
Secondary IDs
ID
Type
Description
Link
NU-98H1
NCI-G00-1739
Brief Title
Peripheral Blood Lymphocyte Therapy to Prevent Lymphoproliferative Disorders Caused by Epstein-Barr Virus in Patients Who Have Undergone Transplantation
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.
Acronym
Not provided
Organization
Northwestern UniversityOTHER
Status Module
Record Verification Date
May 2012
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 2000
Primary Completion Date
Sep 2003Actual
Completion Date
Sep 2003Actual
First Submitted Date
May 2, 2000
First Submission Date that Met QC Criteria
Jan 26, 2003
First Posted Date
Jan 27, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Feb 16, 2011
Certification/Extension First Submitted that Passed QC Review
Feb 16, 2011
Certification/Extension First Posted Date
Feb 18, 2011Estimated
Last Update Submitted Date
May 31, 2012
Last Update Posted Date
Jun 6, 2012Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Northwestern UniversityOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
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.
Conditions Module
Conditions
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Keywords
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
recurrent childhood acute lymphoblastic leukemia
recurrent adult Hodgkin lymphoma
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
isolated plasmacytoma of bone
extramedullary plasmacytoma
stage 0 chronic lymphocytic leukemia
stage I multiple myeloma
stage II multiple myeloma
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
Not provided
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes
Biological
autologous Epstein-Barr virus-specific cytotoxic T lymphocytes
Biological
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Patients who have received or will receive a solid organ transplant or T cell depleted bone marrow transplant
Epstein Barr virus (EBV) DNA detectable and seronegative OR
EBV seropositive
Fully matched or one HLA antigen mismatched sibling donor
HIV negative
Hepatitis B surface antigen negative
Hepatitis C antibody negative
No older than 65 years
No prior primary malignancy within the past 5 years in donor except previously resected skin cancer
PATIENT CHARACTERISTICS:
Age:
Not specified
Performance status:
Not specified
Life expectancy:
Not specified
Hematopoietic:
Not specified
Hepatic:
Not specified
Renal:
Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
Not specified
Endocrine therapy
Not specified
Radiotherapy
Not specified
Surgery
Not specified
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
Not provided
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Ann Traynor, MD
Robert H. Lurie Cancer Center
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago
Illinois
60611
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
stage III multiple myeloma
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
recurrent adult acute lymphoblastic leukemia
refractory chronic lymphocytic leukemia
untreated adult acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia
adult acute lymphoblastic leukemia in remission
childhood acute lymphoblastic leukemia in remission