NCT00058604

Brief Summary

Patients who may have been infected with EBV (Epstein-Barr Virus) before or after the time of their transplant have a higher risk of developing Lymphoproliferative Disease (LPD) or may already have a form of this disease. This research study uses Epstein Barr virus (EBV) specific cytotoxic T lymphocytes (CTLs). These cells have been trained to attack and kill (cytotoxic) EB virus infected cells. We make these cells from the patients blood by first growing an EBV infected B cell line by infecting the blood with an EBV virus called B-95. We then treat these EBV infected B cells with radiation so they cannot grow and use them to stimulate T cells. This stimulation will train the T cells to kill EBV infected cells. We will then test the T cells to make sure they kill the EBV infected cells. The purpose of this study is to find the largest safe dose of EBV specific CTLs, to learn what the side effects are, and to see whether this therapy might help prevent or cure EBV related cancers in solid organ transplant patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2001

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 9, 2003

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

7.9 years

First QC Date

April 8, 2003

Last Update Submit

January 15, 2020

Conditions

Epstein-Barr Virus InfectionsLymphoproliferative Disorders

Outcome Measures

Primary Outcomes (3)

  • Generate autologous, EBV-specific, cytotoxic T cell lines (CTLs) from individuals receiving or having received a solid organ transplant (SOT).

    pre-treatment

  • Administer autologous, EBV-specific CTLs to patients, to determine the safety of intravenous injections in these individuals

    1 year

  • Evaluate the antiviral and immunological efficacy of the infused CTLs

    1 year

Study Arms (1)

Treatment

EXPERIMENTAL

Each patient will receive a Biological/Vaccine Intravenous injection of EBV specific CTLs

Biological: Intravenous injection of EBV specific CTLs

Interventions

Intravenous injection of EBV specific CTLsBIOLOGICAL

Each patient will receive injections of 2x10e7 , 5x10e7 , or 10e8 CTLs/m2 via IV injection. 6 weeks = 1 course

Treatment

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients falling into one of the following categories:
  • Organ transplant recipients at high risk of developing LPD:
  • EBV seronegative recipients
  • Organ transplant recipients receiving OKT3 for immunosuppression
  • Organ transplant recipients with evidence of LPD
  • Organ transplant recipients with EBV DNA level \>1,000 copies
  • Age \<70 yrs old
  • Signed informed consent obtained from patient/guardian
  • CTLs available
  • Performance status; ECOG £ 2
  • Creatinine \< 3X normal
  • Bilirubin \< 5X normal
  • AST \< 5X normal
  • Has not received any other investigational cellular therapies within the past 30 days.

You may not qualify if:

  • Patients with a severe intercurrent infection
  • Patients with life expectancy of less than 6 weeks
  • Patients receiving supplemental oxygen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Epstein-Barr Virus InfectionsLymphoproliferative Disorders

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Helen Heslop, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor/Director Center for Cell and Gene Therapy

Study Record Dates

First Submitted

April 8, 2003

First Posted

April 9, 2003

Study Start

January 1, 2001

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

US(2)