EBV Associated LymphomaPhase 1NCT01823718
Cell Bank of Epstein Barr Virus Specific Cytotoxic T Lymphocytes
A Phase 1 study testing Injection of allogenic CTL EBV specific in people with EBV Associated Lymphoma, run by Nantes University Hospital at 7 sites in France.
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. Read more about this study
- Who is it for?
- Ages 12 months and older
- Conditions the study is for
- EBV Associated Lymphoma
- What is being tested?
- Injection of allogenic CTL EBV specific
- Type of treatment
- Injection or infusion
- How many people
- 18 participants
- Where
- 7 sitesFrance
- Study dates
- Feb 2007to Aug 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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 locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHU de Bordeaux
Bordeaux
CHU de Brest
Brest
CHU de Lille
Lille
CHU de Limoges
Limoges
CHU de Nantes
Nantes
Hopital Pitié Salpétrière
Paris
Hôpital Necker
Paris
About this study
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
- Being tested
- Injection of allogenic CTL EBV specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of allogenic CTL EBV specificBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of one to three injections of allogenic EBV specific CTLs will be determined through adverse event measurement
Measured: 3 months post last injection
Secondary outcomes (1)
To determine the survival, and anti-tumor effects of EBV specific cytotoxic T-lymphocyte lines.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startFeb 2007
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EBV Associated LymphomaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823718
- Sponsor's protocol ID
- 04/7-M
- Status last verified
- Mar 2013
- First submitted
- 29 Mar 2013
- Last updated
- 15 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24598452
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell Bank of Epstein Barr Virus Specific Cytotoxic T Lymphocytes
- ClinicalTrials.gov ID
- NCT01823718
- Acronym / sponsor ID
- 04/7-M
- Conditions
- EBV Associated Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection of allogenic CTL EBV specific | Biological | – |
Primary outcome
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
1 secondary outcome
To determine the survival, and anti-tumor effects of EBV specific cytotoxic T-lymphocyte lines.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2013.
- Derived from this study: PubMed 24598452Gallot 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Injection of allogenic CTL EBV specific in people with EBV Associated Lymphoma, run by Nantes University Hospital at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01823718, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2013.