Cell Bank of Epstein Barr Virus Specific Cytotoxic T Lymphocytes
This trial is active, not recruiting.
|Condition||ebv associated lymphoma|
|Treatment||injection of allogenic ctl ebv specific|
|Sponsor||Nantes University Hospital|
|Start date||February 2007|
|End date||August 2014|
|Trial size||18 participants|
|Trial identifier||NCT01823718, 04/7-M|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Bordeaux, France||CHU de Bordeaux||no longer recruiting|
|Brest, France||CHU de Brest||no longer recruiting|
|Lille, France||CHU de Lille||no longer recruiting|
|Limoges, France||CHU de Limoges||no longer recruiting|
|Nantes, France||CHU de Nantes||no longer recruiting|
|Paris, France||Hôpital Necker||no longer recruiting|
|Paris, France||Hopital Pitié Salpétrière||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
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
To determine the survival, and anti-tumor effects of EBV specific cytotoxic T-lymphocyte lines.
time frame: 1 year
Male or female participants at least 12 months old.
- 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
- 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
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