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Phase 1
12 Months
N/A
Open (Enrolling)
Both
EBV Associated Lymphoma

Thank you

Trial Information


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The safety of one to three injections of allogenic EBV specific CTLs will be determined through adverse event measurement

Outcome Time Frame:

3 months post last injection

Safety Issue:

Yes

Authority:

France : ANSM

Study ID:

04/7-M

NCT ID:

NCT01823718

Start Date:

February 2007

Completion Date:

August 2014

Related Keywords:

  • EBV Associated Lymphoma
  • Lymphoma

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