Cell Bank of Epstein Barr Virus Specific Cytotoxic T Lymphocytes

NCT01823718 | Unknown Phase 1 DMC

• 1 other identifier: 04/7-M
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 7

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 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.

Conditions

EBV Associated Lymphoma

Outcome Measures

Primary Outcomes (1)

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

  3 months post last injection

Secondary Outcomes (1)

• To determine the survival, and anti-tumor effects of EBV specific cytotoxic T-lymphocyte lines.

  1 year

Other Outcomes (1)

• biological monitoring

  12 months

Interventions

Injection of allogenic CTL EBV specific BIOLOGICAL

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (7)

CHU de Bordeaux

Bordeaux, France

Location

CHU de Brest

Brest, France

Location

CHU de Lille

Lille, France

Location

CHU de Limoges

Limoges, France

Location

CHU de Nantes

Nantes, France

Location

Hopital Pitié Salpétrière

Paris, France

Location

Hôpital Necker

Paris, France

Location

Related Publications (1)

• Gallot G, Vollant S, Saiagh S, Clemenceau B, Vivien R, Cerato E, Bignon JD, Ferrand C, Jaccard A, Vigouroux S, Choquet S, Dalle JH, Frachon I, Bruno B, Mothy M, Mechinaud F, Leblond V, Milpied N, Vie H. T-cell therapy using a bank of EBV-specific cytotoxic T cells: lessons from a phase I/II feasibility and safety study. J Immunother. 2014 Apr;37(3):170-9. doi: 10.1097/CJI.0000000000000031.

  PMID: 24598452 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2013
• First Posted: April 4, 2013
• Study Start: February 1, 2007
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 15, 2013

Record last verified: 2013-03

Locations

FR (7)