Immunotherapy for Lymphoproliferative Diseases Associated With Epstein-Barr Virus in Patients Who Have Undergone Organ Transplants

Lymphoma Clinical Trial

Official title:

A Phase I Pilot Trial to Evaluate the Toxicity of Allogeneic Epstein-Barr Virus Specific T-Lymphocytes for the Treatment of EBV-Associated Lymphoproliferative Diseases in Organ Transplant Recipients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00002956
• Other study ID #: CDR0000065433
• Secondary ID: UAB-9739IUMC-961
• Status: Withdrawn
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: August 2, 2013
• Start date: November 1996
• Est. completion date: February 2002

Study information

• Verified date: November 2012
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Donor lymphocytes that have been exposed to Epstein-Barr virus may be able to help the body kill cancers associated with this virus.

PURPOSE: Phase I trial to study the effectiveness of Epstein-Barr virus-specific T cells derived from matched donors in organ transplant patients with lymphoproliferative diseases associated with Epstein-Barr virus.

Description:

OBJECTIVES: I. Examine the toxic effects of allogeneic Epstein-Barr virus (EBV) specific cytotoxic T lymphocytes (CTL) for the treatment of EBV lymphoproliferative diseases (LPD) in organ transplant recipients. II. Determine the level of in vivo expansion of allogeneic CTL and the period of time during which these CTL's can be detected in the blood of recipients of the T cell infusions.

OUTLINE: Donors undergo leukapheresis, and Epstein-Barr virus (EBV) specific cytoxic T lymphocytes are cultivated in vitro. Patients receive infusions of EBV specific cytotoxic T lymphocytes over 5 to 10 minutes on weeks 0, 2, and 4. Patients with stable disease and those achieving partial remission are followed weekly for signs of disease progression.

PROJECTED ACCRUAL: 10 patients will be accrued in this study.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2002
• Est. primary completion date: February 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS: Radiographic evidence of lymphadenopathy or lymphomatous lesions combined with clinical signs of Epstein-Barr virus lymphoproliferative disease (EBV LPD), such as fevers and lymphadenopathy, following an organ transplant Persistent, progressive, or unresponsive disease despite decreased immunosuppression, chemotherapy, or radiation therapy EBV LPD must be of host origin

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: At least 4 weeks Hematopoietic: Not specified Hepatic: Patients serologically hepatitis B and C positive may receive cytotoxic T lymphocytes (CTL) from donors who are serologically positive for the same virus No hepatic dysfunction SGOT/SGPT less than 2.5 times upper limit of normal (unless liver metastases present) Bilirubin less than 2.0 mg/dL Renal: No renal dysfunction Creatinine clearance at least 50 mL/min Cardiovascular: No cardiac dysfunction Neurologic: No neurologic dysfunction Pulmonary: No pulmonary dysfunction Other: (patient) Must have an HLA identical or HLA haploidentical donor No patients developing EBV LPD who have a donor origin lymphoma Patients serologically positive for cytomegalovirus positive may receive CTL from donors who are serologically positive for the same virus (donor) Not HIV-1 positive Medically fit to undergo leukapheresis Donor CTL must be capable of lysing patient B lymphoblastoid cell line (BLCL) in vitro

PRIOR CONCURRENT THERAPY: Not specified

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Lymphoproliferative Disorders

Intervention

Biological:
• allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes

Locations

Country	Name	City	State
United States	University of Alabama Comprehensive Cancer Center	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events associated with administration of allogeneic Epstein-Barr virus (EBV) specific cytotoxic T lymphocytes (CTL) for the treatment of EBV lymphoproliferative diseases (LPD) in organ transplant recipients		baseline to x weeks post infusion	Yes
Primary	Mean length of time of allogeneic CTL during which these CTL's can be detected in the blood of recipients of the T cell infusions.		baseline to x weeks past infusion	No