This trial is active, not recruiting.

Condition ebv associated lymphoma
Treatment injection of allogenic ctl ebv specific
Phase phase 1
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

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 12 months old.

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

Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Nantes University Hospital.