Status:
UNKNOWN
Cell Bank of Epstein Barr Virus Specific Cytotoxic T Lymphocytes
Lead Sponsor:
Nantes University Hospital
Conditions:
EBV Associated Lymphoma
Eligibility:
All Genders
12+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2014
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01823718
Start Date
February 1 2007
End Date
August 1 2014
Last Update
November 15 2013
Active Locations (7)
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1
CHU de Bordeaux
Bordeaux, France
2
CHU de Brest
Brest, France
3
CHU de Lille
Lille, France
4
CHU de Limoges
Limoges, France