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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

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

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2012-08-31

Brief Summary

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

RATIONALE: Vaccines made from a person's white blood cells may help the body build an effective immune response.

PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients who are being considered for solid organ transplant who are at risk for post-transplant lymphoproliferative disorder.

Related Clinical Trials

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

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

NCT00002956

Leukemia Lymphoma

WITHDRAWN PHASE1

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

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

NCT00033475

Lymphoproliferative Disorder

COMPLETED PHASE3

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

Patient-donor Vaccination in the Context of Allogeneic Bone Marrow Transplant With Post-transplant Cyclophosphamide

NCT01282216

Transplant-Related Cancer

TERMINATED PHASE2

Detailed Description

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

OBJECTIVES:

Primary

* Determine the efficacy of photochemically-treated autologous Epstein-Barr virus (EBV)-transformed B-lymphoblastoid cell vaccine in generating an EBV-specific T-cell and antibody response in EBV-negative patients or in boosting the response in EBV-positive patients who are being considered for a solid organ transplant and are at high risk for post-transplant lymphoproliferative disorder.
* Determine adverse events associated with this vaccine in these patients.
* Determine the ability of the vaccine to protect from EBV primary infection in EBV-seronegative patients during the time course of the study.

OUTLINE: This is a nonrandomized, pilot study. Patients are stratified according to Epstein-Barr virus (EBV) status (seropositive vs seronegative).

Patients receive photochemically-treated autologous EBV-transformed B-lymphoblastoid cell vaccine intradermally once in weeks 0 and 4.

After completion of study treatment, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Conditions

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

Lymphoproliferative Disorder

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

PARALLEL

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.

EBV Seronegative

Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were negative for Epstein-Barr Virus (EBV) at baseline.

Group Type EXPERIMENTAL

Inactivated EBV-infected vaccine

Intervention Type BIOLOGICAL

EBV Seropositive

Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were positive for Epstein-Barr Virus (EBV) at baseline.

Group Type EXPERIMENTAL

Inactivated EBV-infected vaccine

Intervention Type BIOLOGICAL

Interventions

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

Inactivated EBV-infected vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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

Inclusion Criteria

DISEASE CHARACTERISTICS:

* Being considered for a solid organ transplant
* At high risk for post-transplant lymphoproliferative disorder

PATIENT CHARACTERISTICS:

* Body weight ≥ 25 kg
* Karnofsky performance status 50-100% OR
* Lansky performance status 50-100%
* Not pregnant
* Negative pregnancy test
* Fertile patients must use contraception during and for 2 months after completion of study treatment
* Hemoglobin ≥ 8 g/dL (erythropoietin allowed)
* No history of autoimmune disease, including any of the following:

* Systemic lupus erythematosus
* Sarcoidosis
* Rheumatoid arthritis
* Glomerulonephritis
* Vasculitis
* No primary immunodeficiency
* No HIV positivity

PRIOR CONCURRENT THERAPY:

* No corticosteroids for 1 month before and for 1 month after the first study vaccination, except for the following:

* Physiologic steroid dosing (≤ 20 mg/day of prednisone or steroid equivalent) for adrenal insufficiency
* Inhaled steroids

Eligible Sex

ALL

Accepts Healthy Volunteers

No