Suspended

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

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What is being tested

allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes

Biological
Who is being recruted

Chronic Disease+36

+ DNA Virus Infections

+ Hematologic Diseases

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: November 1996
See protocol details

Summary

Principal SponsorUniversity of Alabama at Birmingham
Last updated: March 21, 2016
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Study start date: November 1, 1996

Actual date on which the first participant was enrolled.

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.

NCT00002956
Principal SponsorUniversity of Alabama at Birmingham
Last updated: March 21, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseDNA Virus InfectionsHematologic DiseasesHemic and Lymphatic DiseasesHerpesviridae InfectionsImmune System DiseasesImmunoproliferative DisordersInfectionsLeukemia, LymphoidLymphatic DiseasesLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and SymptomsTumor Virus InfectionsVirus DiseasesLeukemia, B-CellLeukemia, T-CellHistiocytosisHistiocytic Disorders, MalignantLymphoma, B-CellEpstein-Barr Virus InfectionsDisease AttributesBurkitt LymphomaHodgkin DiseaseLeukemiaLymphomaLymphoma, FollicularLymphoma, Non-HodgkinRecurrenceLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Large-Cell, ImmunoblasticLymphoma, Large B-Cell, DiffuseLymphoma, B-Cell, Marginal ZoneLymphoma, Mantle-CellLeukemia, Large Granular LymphocyticPrecursor Cell Lymphoblastic Leukemia-LymphomaDendritic Cell Sarcoma, Interdigitating

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Alabama Comprehensive Cancer Center

Birmingham, United StatesOpen University of Alabama Comprehensive Cancer Center in Google Maps
SuspendedOne Study Center