Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed Not specified NCI NU-98H1 NCI-G00-1739, NCT00005606

Objectives

1. 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.
2. Determine the efficacy of these regimens as treatment and prophylaxis in those patients who develop EBV viremia or EBV induced lymphoproliferative disease.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Patient Characteristics:

Age:

• Not specified

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Expected Enrollment

A total of 10-20 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Ann Traynor, MD, Protocol chair(Contact information may not be current)		Ph: 312-908-0059

Registry Information
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.
Trial Start Date		2000-02-11
Registered in ClinicalTrials.gov		NCT00005606
Date Submitted to PDQ		2000-03-03
Information Last Verified		2004-04-08
NCI Grant/Contract Number		P30-CA60553

Back to Top