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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

1996-11-30

Study Completion Date

2002-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00005606

Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm

COMPLETED PHASE2

Vaccine Therapy For Patients Being Considered For Organ Transplant Who Are at Risk For PTLD

NCT00278200

Lymphoproliferative Disorder

TERMINATED PHASE1

Improved Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation Protocol for the Treatment of Epstein Barr Virus T/NK Lymphoproliferative Disease (EBV-T/NK LPD) and Prevention of Post Transplant Graft-versus-host Disease

NCT07029958

EBV-T/NK LPD

RECRUITING PHASE4

Reduced Immunosuppressive Therapy With or Without Donor White Blood Cells in Treating Patients With Lymphoproliferative Disease After Organ Transplantation

NCT00033475

Lymphoproliferative Disorder

COMPLETED PHASE3

Most Closely HLA Matched Allogeneic Virus Specific Cytotoxic T-Lymphocytes (CTL)

NCT00711035

Adenovirus Infection EBV Infection

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Leukemia Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

infusions of EBV specific cytotoxic T lymphocytes

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

Group Type EXPERIMENTAL

allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes

Intervention Type BIOLOGICAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
* At least 4 weeks
* Patients serologically hepatitis B and C positive may receive cytotoxic
* T- lymphocytes (CTL) from donors who are serologically positive for the same virus
* Must have an HLA identical or HLA haploidentical donor

Exclusion

* 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 dysfunction
* Creatinine clearance at greater than 50 mL/min
* cardiac dysfunction
* neurologic dysfunction
* pulmonary dysfunction
* patients developing EBV LPD who have a donor origin lymphoma
* HIV-1 positive
* Not capable of undergoing leukapheresis

Eligible Sex

ALL

Accepts Healthy Volunteers

No