Cell Bank of Epstein Barr Virus Specific Cytotoxic T Lymphocytes

Sponsor

Nantes University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01823718

Collaborator

(none)

Enrollment

Locations

Duration (Months)

2.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
EBV Associated Lymphoma	Biological: Injection of allogenic CTL EBV specific	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Feb 1, 2007

Anticipated Primary Completion Date :

Aug 1, 2014

Anticipated Study Completion Date :

Aug 1, 2014

Outcome Measures

Primary Outcome Measures

The safety of one to three injections of allogenic EBV specific CTLs will be determined through adverse event measurement [3 months post last injection]

Secondary Outcome Measures

To determine the survival, and anti-tumor effects of EBV specific cytotoxic T-lymphocyte lines. [1 year]

Other Outcome Measures

biological monitoring [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Months and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	CHU de Bordeaux	Bordeaux	France
2	CHU de Brest	Brest	France
3	CHU de Lille	Lille	France
4	CHU de Limoges	Limoges	France
5	CHU de Nantes	Nantes	France
6	Hopital Pitié Salpétrière	Paris	France
7	Hôpital Necker	Paris	France

Sponsors and Collaborators

Nantes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT01823718

Other Study ID Numbers:

04/7-M

First Posted:

Apr 4, 2013

Last Update Posted:

Nov 15, 2013

Last Verified:

Mar 1, 2013

Study Results

No Results Posted as of Nov 15, 2013