Hodgkin LymphomaPhase 2CIVICNCT02763254
Cellular Immunotherapy for Viral Induced Cancer - EBV Positive Lymphomas
A Phase 2 study testing baltaleucel-T in people with Hodgkin Lymphoma and Lymphoma, Large B-Cell, Diffuse, run by Cell Medica Ltd at 1 site in United States.
Trial summary
To investigate the efficacy of autologous Epstein-barr virus (EBV)-specific T cells for the treatment of EBV positive Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and Post-transplant Lymphoproliferative Disease (PTLD) after failing first line treatment. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hodgkin Lymphoma, Lymphoma, Large B-Cell, Diffuse, Post-transplant Lymphoproliferative Disorder
- What is being tested?
- baltaleucel-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 17 Feb 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The study will include three primary cohorts, with any of the following EBV+ diseases:
- Cohort A - DLBCL, 1) in first or subsequent relapse, not eligible for autologous transplantation following salvage therapy OR 2) relapse following autologous transplantation.
- Cohort B - HL, brentuximab vedotin (BV) treatment failure or unable to tolerate BV.
- Cohort C - PTLD, rituximab treatment failure.
- Presence of active lymphoma or active PTLD, based on imaging performed within the previous 3 months.
- Tumor positive for EBV encoded RNA (EBER) based on report from certified laboratory.
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- Absolute lymphocyte count (ALC) >500/µL
- Male or female ≥ 12 years of age
- Weight ≥ 35 kg
- Eastern Cooperative Oncology Group (ECOG) performance score 0-2, inclusively or Lansky score ≥ 60, as age appropriate
- Able to understand and comply with the requirements of the study and to provide written informed consent or age appropriate assent for pediatric patients.
Who cannot join
- Known central nervous system (CNS) lymphoma
- Primary refractory HL or DLBCL
- Bulky disease
- Relapse or progression following previous autologous EBV specific T cell treatment.
- Use of systemic corticosteroids > 0.5 mg/kg/day prednisolone or equivalent does of alternative corticosteroid within 10 days prior to obtaining 200 mL starting material
- Positive for HIV, hepatitis B, hepatitis C, syphilis or human T cell leukemia virus (HTLV).
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- Patient is pregnant or lactating
- Systemic fungal, bacterial, viral or other infection that is not controlled
- Prior allogeneic hematopoietic stem cell transplantation (allo HSCT)
- Known history of primary immunodeficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Open Label Study to Investigate the Safety and Clinical Activity of Autologous EBV-specific T Cells (CMD-003) for the Treatment of Patients With EBV Positive Lymphomas
To investigate the efficacy of autologous Epstein-barr virus (EBV)-specific T cells for the treatment of EBV positive Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and Post-transplant Lymphoproliferative Disease (PTLD) after failing first line treatment.
- Conditions
- Hodgkin Lymphoma, Lymphoma, Large B-Cell, Diffuse, Post-transplant Lymphoproliferative Disorder
- Being tested
- baltaleucel-T
- Keywords
- Epstein-Barr Virus, DLBCL, PTLD, EBV, CIVIC, HL, T cell
- Medical subject headings
- Hodgkin Disease, Lymphoma, Large B-Cell, Diffuse, Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
baltaleucel-TBiological
Autologous EBV-specific T cells
| Study group | Role | What they receive |
|---|---|---|
| baltaleucel-T | Experimental | Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks. Receives: Biological: baltaleucel-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Overall Response
Best single observed response, complete response (CR) or partial response (PR) per Lugano 2014 Disease Response Criteria, during 12 month follow-up.
Measured: 1 year
Secondary outcomes (1)
Adverse Events
Adverse events will be recorded from the time of the first investigational cell product dose is administered until 30 days after the last administration. Serious events recorded for up to 1 year after administration.
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 posted5 May 2016 (estimated)
- Study startNov 2016
- Primary completion17 Feb 2018
- Study completion17 Feb 2018
Why it stopped: Insufficient recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cell Medica Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kurt Gunter, MD, Study director, Cell Medica, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763254
- Sponsor's protocol ID
- CM-2015-01
- Acronym
- CIVIC
- Status last verified
- Mar 2019
- First submitted
- 27 Apr 2016
- Last updated
- 26 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open Label Study to Investigate the Safety and Clinical Activity of Autologous EBV-specific T Cells (CMD-003) for the Treatment of Patients With EBV Positive Lymphomas
- ClinicalTrials.gov ID
- NCT02763254
- Acronym / sponsor ID
- CIVIC / CM-2015-01
- Conditions
- Hodgkin Lymphoma, Lymphoma, Large B-Cell, Diffuse, Post-transplant Lymphoproliferative Disorder
- Keywords
- Epstein-Barr Virus, DLBCL, PTLD, EBV, CIVIC, HL, T cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment rate
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Cell Medica LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- 17 Feb 2018 (actual)
- Study completion
- 17 Feb 2018 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Posted 12 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the efficacy of autologous Epstein-barr virus (EBV)-specific T cells for the treatment of EBV positive Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and Post-transplant Lymphoproliferative Disease (PTLD) after failing first line treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| baltaleucel-T | Experimental | Biological: baltaleucel-TTreatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- The study will include three primary cohorts, with any of the following EBV+ diseases:
- Cohort A - DLBCL, 1) in first or subsequent relapse, not eligible for autologous transplantation following salvage therapy OR 2) relapse following autologous transplantation.
- Cohort B - HL, brentuximab vedotin (BV) treatment failure or unable to tolerate BV.
- Cohort C - PTLD, rituximab treatment failure.
- Presence of active lymphoma or active PTLD, based on imaging performed within the previous 3 months.
Key exclusion criteria (10 listed)
- Known central nervous system (CNS) lymphoma
- Primary refractory HL or DLBCL
- Bulky disease
- Relapse or progression following previous autologous EBV specific T cell treatment.
- Use of systemic corticosteroids > 0.5 mg/kg/day prednisolone or equivalent does of alternative corticosteroid within 10 days prior to obtaining 200 mL starting material
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 |
|---|---|---|
| baltaleucel-TAutologous EBV-specific T cells | Biological | baltaleucel-T |
Primary outcome
Best Overall Response
Time frame: 1 year
Best single observed response, complete response (CR) or partial response (PR) per Lugano 2014 Disease Response Criteria, during 12 month follow-up.
1 secondary outcome
Adverse Events
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Kurt Gunter, MD study director
Cell Medica, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing baltaleucel-T in people with Hodgkin Lymphoma and Lymphoma, Large B-Cell, Diffuse, run by Cell Medica Ltd at 1 site in United States.
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 11 inclusion and 10 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: stopped early, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Best Overall Response (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2019.