Cell Bank of Epstein Barr Virus Specific Cytotoxic T Lymphocytes

November 14, 2013 updated by: Nantes University Hospital

Patients patients enrolled in this study have a Lymphoma caused by EBV (after bone marrow transplantation, organ transplantation or patient immunodeficient.

They will receive one to three injections of allogenic CTL specific EBV.

The purpose of this study is to ensure that these injections can not cause a GVH and to study what the side effects are and to see whether this therapy might help patients with Lymphoma.

Immunological monitoring will also be studied.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • CHU de Bordeaux
      • Brest, France
        • CHU de Brest
      • Lille, France
        • CHU de Lille
      • Limoges, France
        • CHU de Limoges
      • Nantes, France
        • CHU de Nantes
      • Paris, France
        • Hopital Pitie Salpetriere
      • Paris, France
        • Hopital Necker

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, without immunosuppressed organ transplant or immunocompromised and who received a kidney transplant, or kidney-pancreas, or heart or lung or heart-lung, or liver, or cells hematopoietic stem cells, and has given its consent
  • Aged 18 to 75 years Children aged more than 12 months,
  • PS <4
  • Viral load determined EBV
  • Life expectancy> 1 month
  • Patient typed for HLA DP DQ DR ABC
  • Patients with lymphoma in the immunosuppressed associated with EBV and failure, partial response (<50%) or relapsed after treatment with monoclonal antibodies and / or chemotherapy completed for at least three weeks. Patients with partial response may have a PET scan to confirm the lack of response.
  • Patient with a measurable mass to assess the response or bone marrow infiltration and / or measurable blood and having frozen tumor material or having a repeat biopsy.
  • Availability of a CTL matching at least two HLA or one HLA after validation experts with tumor cells
  • test de cytotoxicity negative

Exclusion Criteria:

  • Patient Pregnant or lactating
  • Concurrent infection with HIV
  • EBV negative lymphomas
  • If acute GVHD> grade II J-1 before injection (case grafts CSH)
  • Treatment of molecules in pre-marketing authorization older than 21 days
  • No matching at least two CTL HLA or non expert validation for the use of CTL with HLA sharing a single tumor
  • Test of cytotoxicity positive
  • Lack of recognition of tumor cells when available

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The safety of one to three injections of allogenic EBV specific CTLs will be determined through adverse event measurement
Time Frame: 3 months post last injection
3 months post last injection

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the survival, and anti-tumor effects of EBV specific cytotoxic T-lymphocyte lines.
Time Frame: 1 year
1 year

Other Outcome Measures

Outcome Measure
Time Frame
biological monitoring
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (ANTICIPATED)

August 1, 2014

Study Completion (ANTICIPATED)

August 1, 2014

Study Registration Dates

First Submitted

March 29, 2013

First Submitted That Met QC Criteria

March 29, 2013

First Posted (ESTIMATE)

April 4, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 15, 2013

Last Update Submitted That Met QC Criteria

November 14, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 04/7-M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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