Cell Bank of Epstein Barr Virus Specific Cytotoxic T Lymphocytes

EBV Associated Lymphoma Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01823718
• Other study ID #: 04/7-M
• Status: Active, not recruiting
• Phase: Phase 1
• First received: March 29, 2013
• Last updated: November 14, 2013
• Start date: February 2007
• Est. completion date: August 2014

Study information

• Verified date: March 2013
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : ANSM
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• EBV Associated Lymphoma

Intervention

Biological:
• Injection of allogenic CTL EBV specific

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux
France	CHU de Brest	Brest
France	CHU de Lille	Lille
France	CHU de Limoges	Limoges
France	CHU de Nantes	Nantes
France	Hôpital Necker	Paris
France	Hopital Pitié Salpétrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	biological monitoring		12 months	No
Primary	The safety of one to three injections of allogenic EBV specific CTLs will be determined through adverse event measurement		3 months post last injection	Yes
Secondary	To determine the survival, and anti-tumor effects of EBV specific cytotoxic T-lymphocyte lines.		1 year	No