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Cellular Immunotherapy Treatment Antigen-Directed for EBV Lymphoma (CITADEL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01948180
Recruitment Status : Terminated (Insufficient enrollment rate)
First Posted : September 23, 2013
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Cell Medica Ltd

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Lymphoma, Extranodal NK-T-Cell EBV Biological: baltaleucel-T Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 2014
Actual Primary Completion Date : April 16, 2018
Actual Study Completion Date : September 7, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: baltaleucel-T

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.

 Biological: baltaleucel-T
Autologous EBV-specific T-cells
Other Name: CMD-003


Outcome Measures
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Primary Outcome Measures :
  1. Overall response rate [ Time Frame: 1 year ]
    Defined as best observed response (complete response or partial response) per Lugano 2014 Disease Response Criteria.


Secondary Outcome Measures :
  1. Complete Response Rate [ Time Frame: 1 year ]
  2. Response Duration [ Time Frame: 2 years ]
  3. Time to Response [ Time Frame: 1 year ]
  4. Progression Free Survival [ Time Frame: 2 years ]
  5. Disease Free Survival [ Time Frame: 2 years ]
  6. Overall Survival [ Time Frame: 2 years ]
  7. Adverse Events [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Immunological assessment of EBV-specific T-cell activity and phenotyping [ Time Frame: 1 year ]
  2. Monitor levels of plasma and whole blood EBV DNA (viral load) [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

FOR SCREENING PHASE:

Inclusion Criteria:

  1. 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.
  2. a) Active Disease

(1) 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.

Exclusion Criteria:

  1. CNS lymphoma.
  2. NK cell leukemia.
  3. Hemophagocytic lymphohistiocytosis.
  4. Positive for HIV, hepatitis B, hepatitis C, syphilis or human T Cell leukemia virus (HTLV).
  5. Use of systemic corticosteroids >0.5 mg/kg/day within 10 days prior to obtaining 200 mL whole blood starting material.
  6. Patient is pregnant or lactating.
  7. Active second malignancy.
  8. Any prior allogeneic hematopoietic stem cell or solid organ transplant.

  9. Asparaginase refractory disease, defined by any one of the following:

    1. Progression at any time during initial asparaginase based chemotherapy and up to 3 months after end of initial asparaginase based chemotherapy, OR
    2. Failure to achieve at least PR with initial asparaginase based chemotherapy.
  10. Absolute lymphocyte count (ALC) <400/µL.
  11. Any previous autologous EBV specific T cell treatment.
  12. Systemic fungal, bacterial, viral or other infection that is not controlled.
  13. Third or greater relapse.

FOR TREATMENT PHASE:

Inclusion Criteria:

  1. Documented relapse or progression following at least one prior cycle of an asparaginase-containing chemotherapy regimen.

  2. 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:

    1. Imaging (may use local imaging)
    2. Clinical sign(s) including skin lesions consistent with lymphoma, organ dysfunction or organomegaly not attributable to other causes; or other clinical sign(s)
    3. Detectable blood or plasma ENV DNA (may use local laboratory)
  3. Completed most recent course of chemotherapy at least 2 weeks prior to first study drug dose.
  4. Recovery from acute hematological, hepatic and renal chemotherapy-related toxicities as defined by ≤ Grade 1 according to NCI CTCAE v4.0.
  5. Life expectancy ≥ 8 weeks.

Exclusion Criteria:

  1. Use of any investigational agents within prior 4 weeks.
  2. Radiotherapy within prior 3 weeks.
  3. Major surgery within prior 2 weeks.
  4. Systemic corticosteroids within 24 hours prior to study drug administration.
  5. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01948180


Locations
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United States, Massachusetts
Dana-Farber Cancer Center
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Ohio
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
MD Anderson Cancer Center
Houston, Texas, United States, 77030
France
Universitaire Ouest
Paris, France, 75015
Centre Hospitalier de Lyon
Pierre Bénite, France, 69310
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Asan Cancer Center
Seoul, Korea, Republic of, 138-736
United Kingdom
University College London Hospital
London, UK, United Kingdom, NW1 2PG
The Christie Clinic
Manchester, UK, United Kingdom, M20 4BX
Sponsors and Collaborators
Cell Medica Ltd
Investigators
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Principal Investigator: Helen Heslop, MD Baylor College of Medicine
Study Director: Kurt Gunter, MD Cell Medica
More Information
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Responsible Party: Cell Medica Ltd
ClinicalTrials.gov Identifier: NCT01948180    
Other Study ID Numbers: CM-2013-01
First Posted: September 23, 2013    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cell Medica Ltd:
NKTCL
T cell
CITADEL
Epstein-Barr Virus
Natural Killer
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Extranodal NK-T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin