Lymphoma, Extranodal NK-T-CellPhase 2CITADELNCT01948180
Cellular Immunotherapy Treatment Antigen-Directed for EBV Lymphoma
A Phase 2 study testing baltaleucel-T in people with Lymphoma, Extranodal NK-T-Cell and EBV, run by Cell Medica Ltd at 11 sites in 4 countries.
Trial summary
To investigate the efficacy of autologous EBV-specific T-cells for the treatment of patients with aggressive EBV positive extranodal NK/T-cell lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Extranodal NK-T-Cell, EBV
- 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
- 15 participants
- Where
- 11 sitesin 4 countries
- Study dates
- Sep 2014to 7 Sep 2018
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of extranodal NK/T lymphoma, per WHO classification, 4th ed., which must include EBV tumor positivity, measured either by EBV encoded RNA (EBER) or LMP1 immunostaining.
- a) Active Disease
- Clinically suspected or documented relapse/progression, in first or second relapse following at least one cycle of an asparaginase-based chemotherapy regimen OR (2) Initial disease or first or second relapse and unable to tolerate one full cycle of asparaginase-based chemotherapy regimen OR b) High-risk disease (stage III/IV, KPI groups 3-4 or IPI intermediate-high) prior to second CR regardless of previous chemotherapy.
- 3. Male or female ≥ 18 years of age. 4. Weigh ≥ 35 kg. 5. ECOG performance score 0-2, inclusively. 6. Negative β-hCG test in women of childbearing potential. 7. Able to understand and comply with the requirements of the study and to provide written informed consent.
- Documented relapse or progression following at least one prior cycle of an asparaginase-containing chemotherapy regimen.
- Active disease based on any one of the following present at the baseline study visit or within two weeks prior to the baseline study visit:
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- Imaging (may use local imaging)
- Clinical sign(s) including skin lesions consistent with lymphoma, organ dysfunction or organomegaly not attributable to other causes; or other clinical sign(s)
- Detectable blood or plasma ENV DNA (may use local laboratory)
- Completed most recent course of chemotherapy at least 2 weeks prior to first study drug dose.
- Recovery from acute hematological, hepatic and renal chemotherapy-related toxicities as defined by ≤ Grade 1 according to NCI CTCAE v4.0.
- Life expectancy ≥ 8 weeks.
Who cannot join
- CNS lymphoma.
- NK cell leukemia.
- Hemophagocytic lymphohistiocytosis.
- Positive for HIV, hepatitis B, hepatitis C, syphilis or human T Cell leukemia virus (HTLV).
- Use of systemic corticosteroids >0.5 mg/kg/day within 10 days prior to obtaining 200 mL whole blood starting material.
- Patient is pregnant or lactating.
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- Active second malignancy.
- Any prior allogeneic hematopoietic stem cell or solid organ transplant.
- Asparaginase refractory disease, defined by any one of the following:
- Progression at any time during initial asparaginase based chemotherapy and up to 3 months after end of initial asparaginase based chemotherapy, OR
- Failure to achieve at least PR with initial asparaginase based chemotherapy.
- Absolute lymphocyte count (ALC) <400/µL.
- Any previous autologous EBV specific T cell treatment.
- Systemic fungal, bacterial, viral or other infection that is not controlled.
- Third or greater relapse.
- FOR TREATMENT PHASE:
- Use of any investigational agents within prior 4 weeks.
- Radiotherapy within prior 3 weeks.
- Major surgery within prior 2 weeks.
- Systemic corticosteroids within 24 hours prior to study drug administration.
- Evidence of hepatic dysfunction based on serum total bilirubin >3 times upper limit of normal (ULN), or ALT >5 times ULN or AST >5 times ULN.
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
United States5 sites
Dana-Farber Cancer Center
Boston, Massachusetts, 02215
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Baylor College of Medicine
Houston, Texas, 77030
MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic
Rochester, Minnesota, 55905
France2 sites
Universitaire Ouest
Paris, 75015
Centre Hospitalier de Lyon
Pierre-Bénite, 69310
South Korea2 sites
Samsung Medical Center
Seoul, 135-710
Asan Cancer Center
Seoul, 138-736
United Kingdom2 sites
University College London Hospital
London, UK, NW1 2PG
The Christie Clinic
Manchester, UK, M20 4BX
About this study
Official title: A Phase 2 Single Arm Study to Investigate the Efficacy of Autologous EBV-specific T-cells for the Treatment of Patients With Aggressive EBV Positive Extranodal NK/T-cell Lymphoma (ENKTCL)
To investigate the efficacy of autologous EBV-specific T-cells for the treatment of patients with aggressive EBV positive extranodal NK/T-cell lymphoma
- Conditions
- Lymphoma, Extranodal NK-T-Cell, EBV
- Being tested
- baltaleucel-T
- Keywords
- NKTCL, T cell, CITADEL, Epstein-Barr Virus, Natural Killer
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell, 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
Also called CMD-003
Autologous EBV-specific T-cells
| Study group | Role | What they receive |
|---|---|---|
| baltaleucel-T | Experimental | Treatment consists of 2 infusions of 2x10E7 cells/m2 given on Days 1 and 15 intravenously via a peripheral or central line over a 1 to 10 minute period.
Subjects who tolerate the study treatment well and who do not require treatment with an alternative chemotherapeutic agent will be eligible for up to 3 additional infusions of 2x10E7 cells/m2 administered at week 8, month 3 and month 6. Receives: Biological: baltaleucel-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Defined as best observed response (complete response or partial response) per Lugano 2014 Disease Response Criteria.
Measured: 1 year
Secondary outcomes (7)
Complete Response Rate
Measured: 1 year
Response Duration
Measured: 2 years
Time to Response
Measured: 1 year
Progression Free Survival
Measured: 2 years
Disease Free Survival
Measured: 2 years
Overall Survival
Measured: 2 years
Adverse Events
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 posted23 Sep 2013 (estimated)
- Study startSep 2014
- Primary completion16 Apr 2018
- Study completion7 Sep 2018
Why it stopped: Insufficient enrollment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Extranodal NK-T-CellStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cell Medica Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helen Heslop, MD, Principal investigator, Baylor College of MedicineKurt Gunter, MD, Study director, Cell Medica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948180
- Sponsor's protocol ID
- CM-2013-01
- Acronym
- CITADEL
- Status last verified
- Mar 2019
- First submitted
- 13 Sep 2013
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Single Arm Study to Investigate the Efficacy of Autologous EBV-specific T-cells for the Treatment of Patients With Aggressive EBV Positive Extranodal NK/T-cell Lymphoma (ENKTCL)
- ClinicalTrials.gov ID
- NCT01948180
- Acronym / sponsor ID
- CITADEL / CM-2013-01
- Conditions
- Lymphoma, Extranodal NK-T-Cell, EBV
- Keywords
- NKTCL, T cell, CITADEL, Epstein-Barr Virus, Natural Killer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment rate
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Cell Medica LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2014 (actual)
- Primary completion
- 16 Apr 2018 (actual)
- Study completion
- 7 Sep 2018 (actual)
- First posted
- 23 Sep 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.
To investigate the efficacy of autologous EBV-specific T-cells for the treatment of patients with aggressive EBV positive extranodal NK/T-cell lymphoma
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 consists of 2 infusions of 2x10E7 cells/m2 given on Days 1 and 15 intravenously via a peripheral or central line over a 1 to 10 minute period. Subjects who tolerate the study treatment well and who do not require treatment with an alternative chemotherapeutic agent will be eligible for up to 3 additional infusions of 2x10E7 cells/m2 administered at week 8, month 3 and month 6. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosis of extranodal NK/T lymphoma, per WHO classification, 4th ed., which must include EBV tumor positivity, measured either by EBV encoded RNA (EBER) or LMP1 immunostaining.
- a) Active Disease
- Clinically suspected or documented relapse/progression, in first or second relapse following at least one cycle of an asparaginase-based chemotherapy regimen OR (2) Initial disease or first or second relapse and unable to tolerate one full cycle of asparaginase-based chemotherapy regimen OR b) High-risk disease (stage III/IV, KPI groups 3-4 or IPI intermediate-high) prior to second CR regardless of previous chemotherapy.
- 3. Male or female ≥ 18 years of age. 4. Weigh ≥ 35 kg. 5. ECOG performance score 0-2, inclusively. 6. Negative β-hCG test in women of childbearing potential. 7. Able to understand and comply with the requirements of the study and to provide written informed consent.
- Documented relapse or progression following at least one prior cycle of an asparaginase-containing chemotherapy regimen.
Key exclusion criteria (21 listed)
- CNS lymphoma.
- NK cell leukemia.
- Hemophagocytic lymphohistiocytosis.
- Positive for HIV, hepatitis B, hepatitis C, syphilis or human T Cell leukemia virus (HTLV).
- Use of systemic corticosteroids >0.5 mg/kg/day within 10 days prior to obtaining 200 mL whole blood 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-TAlso: CMD-003Autologous EBV-specific T-cells | Biological | baltaleucel-T |
Primary outcome
Overall response rate
Time frame: 1 year
Defined as best observed response (complete response or partial response) per Lugano 2014 Disease Response Criteria.
7 secondary outcomes
Complete Response Rate
Time frame: 1 year
Response Duration
Time frame: 2 years
Time to Response
Time frame: 1 year
Progression Free Survival
Time frame: 2 years
Disease Free Survival
Time frame: 2 years
Overall Survival
Time frame: 2 years
Adverse Events
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Insufficient enrollment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- 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.
Helen Heslop, MD principal investigator
Baylor College of Medicine
Kurt Gunter, MD study director
Cell Medica
11 sites in 4 countries: 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 Lymphoma, Extranodal NK-T-Cell and EBV, run by Cell Medica Ltd at 11 sites in 4 countries.
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 12 inclusion and 21 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 13 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 11 sites in United States, France, South Korea, United Kingdom. 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?
The study was stopped early (reason given: Insufficient enrollment rate). 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?
Overall response rate (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 13 Mar 2019.