NCT00058591

Brief Summary

Severe chronic active Epstein-Barr virus (SCAEBV) is a rare Epstein-Barr virus (EBV or commonly known as mono or the kissing disease) associated disorder. This disorder may cause chronic tiredness and fevers and sometimes be complicated by life threatening problems such as multi-organ failure, chronic (ongoing) pneumonia, and lymphoproliferative diseases (diseases involving the lymph nodes which could eventually show up as leukemia or a tumor). The reasons for the body's inability to control the EBV infection are still unknown and no effective treatment is currently available. This research study uses Epstein-Barr virus (EBV) specific cytotoxic T lymphocytes (CTLs). We want to see if we can grow special white blood cells, called T cells, that have been trained to kill EBV infected cells in the laboratory and see if these cells may help control the EBV infection when given back to the patient. 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 the body fight off the SCAEBV infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2000

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
3.3 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

8.9 years

First QC Date

April 8, 2003

Last Update Submit

January 15, 2020

Conditions

Epstein-Barr Virus Infections

Outcome Measures

Primary Outcomes (1)

  • to determine the safety of intravenous injections of autologous EBV specific cytotoxic T cell lines in individuals with severe chronic EBV infection

    1 yr

Secondary Outcomes (2)

  • determine antiviral and immunological efficacy of intravenous injections of CTLs in these patients

    1 yr

  • assess the clinical effects of these injections

    1 yr

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment dose levels 1, 2 and 3

Biological: Intravenous injection of EBV specific CTLS

Interventions

Intravenous injection of EBV specific CTLSBIOLOGICAL

The dose levels for this study are as follows: Level Dose 1. 2 x 107 CTLs/m2 2. 5 x 107 CTLs/m2 3. 1 x 108 CTLs/m2 If patients have a clinical response to the first infusion defined by an improvement in the fatigue score or resolution of clinical abnormalities such as lymphadenopathy or an improvement in laboratory parameters such as a decrease in VCA titer or reduction in free EBV DNA they will be eligible to receive up to 3 additional injections of CTLs at the original dose at 3 monthly intervals.

Treatment

Eligibility Criteria

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

You may qualify if:

  • Patients must have severe chronic EBV infection as manifested by 6 months of symptoms Either elevated peripheral blood EBV DNA (\>4000 genomes per ug PBMC DNA) or free EBV DNA in serum or CSF or VCA antibody titer \> 1/640
  • Seronegative for HIV
  • Not on investigational agents in the last 4 weeks
  • Signed informed consent obtained from patient/guardian
  • CTLs available
  • Performance status; Karnofsky \>60
  • Creatinine \< 3X normal
  • Bilirubin \< 5X normal
  • Normal electrolytes, calcium, phosphorus, nutritional status
  • Females with child-bearing potential must utilize effective birth control.

You may not qualify if:

  • Patients with a severe intercurrent infection
  • Patients that recently received high dose steroids within the last week or other immunosuppressive drugs within a week (or longer as indicated by the half life of the agent)
  • Patients with life expectancy of less than 6 weeks
  • Pregnant or lactating females

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 Infections

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Study Officials

  • Helen E Heslop, MD

    Center for Cell and Gene Therapy, 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
Director/Professor, Center for Gene Therapy-Administration

Study Record Dates

First Submitted

April 8, 2003

First Posted

April 9, 2003

Study Start

January 1, 2000

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

US(2)