Peripheral Blood Lymphocyte Therapy to Prevent Lymphoproliferative Disorders Caused by Epstein-Barr Virus in Patients Who Have Undergone Transplantation

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00005606
First received: May 2, 2000
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Biological: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes
Biological: autologous Epstein-Barr virus-specific cytotoxic T lymphocytes
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Study Start Date: February 2000
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005606

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Study Chair: Ann Traynor, MD Robert H. Lurie Cancer Center
  More Information

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00005606     History of Changes
Other Study ID Numbers: NU 98H1, NU-98H1, NCI-G00-1739
Study First Received: May 2, 2000
Last Updated: May 31, 2012
Health Authority: United States: Federal Government

Keywords provided by Northwestern University:
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
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
untreated hairy cell leukemia
progressive hairy cell leukemia, initial treatment
refractory hairy cell leukemia

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma
Leukemia
Lymphoproliferative Disorders
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphatic Diseases

ClinicalTrials.gov processed this record on September 30, 2014