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VT-EBV-N for Treatment of Severe in EBV Positive Extranodal NK/T Cell Lymphoma Patients

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03671850
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
ViGenCell Inc.

Brief Summary:
The study aims to evaluate the efficacy and safety of VT-EBV-N (EBV-CTL) administration in ENKL patients after complete remission (CR). This is to prove the effect of VT-EBV-N (EBV-CTL) in prevention of ENKL relapse compared to placebo, by checking the primary endpoint of DFS rate (disease free survival, no relapse or death after randomization) at 2 years (103 weeks) for the last subject enrolled. 50% of the subjects will be administered VT-EBV-N (EBV-CTL), while the remaining subjects will be administered a placebo.

Condition or disease Intervention/treatment Phase
Extranodal NK/T-cell Lymphoma Biological: VT-EBV-N Other: Placebo Phase 2

Detailed Description:

NK/T-cell lymphoma is a malignant tumor originating in NK cells and T lymphocytes. ENKL is associated with Epstein-Barr virus (EBV) infection and typically occurs in the nasal area, being termed ENKL, nasal type.EBV is a common virus in the herpes family. EBV infection in patients with lowered immunity such as those with Acquired Immune Deficiency Syndrome or those taking immunosuppressants after bone marrow transplant may induce lymphoproliferative diseases or cancer.

VT-EBV-N (EBV-CTL) is a cytotoxicity T lymphocyte (CTL) targeting EBV expressed tumor cells indicated for ENKL. Antigen-presenting cells derived from the patient's own blood is used to activate T-cells in a test tube to recognize EBV, which are then expanded in vitro and infused into the patient's body. Targeted immunotherapy using EBV-CTL is a safe form of treatment that can improve long-term disease-free survival rates by boosting antitumor immunity without affecting other tissues apart from tumor cells.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Study to Evaluate the Efficacy and Safety of Postremission Therapy Using VT-EBV-N in EBV Positive Extranodal NK/T Cell Lymphoma Patients
Actual Study Start Date : April 9, 2019
Estimated Primary Completion Date : December 4, 2023
Estimated Study Completion Date : June 3, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: VT-EBV-N
Epstein-barr virus human cytotoxic T lymphocytes (EBV-CTL)
Biological: VT-EBV-N
Epstein-barr virus human cytotoxic T lymphocytes (EBV-CTL)

Placebo Comparator: Placebo
Peripheral blood mononuclear cell, PBMC
Other: Placebo
Peripheral blood mononuclear cell, PBMC




Primary Outcome Measures :
  1. No relapse or death due to any reason after randomization [ Time Frame: Randomization (8 weeks before administration) ~ 116 weeks after treatment period ]

Secondary Outcome Measures :
  1. No death after randomization [ Time Frame: Randomization (8 weeks before administration) ~ 116 weeks after treatment period ]
  2. No relapse or death due to any reason after randomization [ Time Frame: Randomization (116 weeks after treatment period) ~ ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. EBV positive extranodal NK/T cell lymphoma (ENKL) patients pathologically confirmed according to WHO classification at first diagnosis
  2. Patients whose complete remission (CR) has been confirmed within 6 months before screening and maintained, presenting high risk of relapse due to one or more of the following 1) Patients who are EBV detectable at initial diagnosis, with one or more of the following high risk factors 60 years of age or older, Ann Arbor stage II ~ IV, non-nasal type disease, local invasiveness (defined with T3 or T4), elevated LDH (> upper limit of normal)) 2) Patients confirmed to have EBV DNAemia (> 2000 copies/ml) during or after treatment 3) Patients who achieved remission from secondary or greater remission induction therapy after the failure of primary remission induction, or achieved remission after relapse
  3. 19 years and above to 75 years and below
  4. Patients with ECOG performance criteria score of 0 to 2
  5. Patients with acceptable hematopoietic function (ANC ≥ 1.5 x 109 /L, PLT ≥ 100 x 109 /L, Hb ≥ 9 g/dL)
  6. Patients with acceptable liver function (total bilirubin < 2 x upper limit of normal, AST/ALT < 3 x upper limit of normal)
  7. Patients with renal function of eGFR > 50 or better
  8. Patients with life expectancy of 6 or longer
  9. Patients who have agreed to use two different types of birth control during the study period (Females of childbearing age or within 2 years after menopause have to show negative results in urine pregnancy test) (E.g., dual contraception using oral contraceptives, contraceptive implant, contraceptive injection, or contraceptive patch combined with intrauterine device, spermicide foam or gel, contraceptive film, vaginal diaphragm, cervical cap, condom, etc.)
  10. Patients who have voluntarily given written consent to participate in this study

Exclusion Criteria:

  1. Other pathological classifications of nasal cavity lymphoma than ENKL at initial diagnosis
  2. Patients with ENKL that has invaded the central nervous system
  3. Patients in PR, SD or PD state, not complete remission (CR)
  4. Patients who cannot generate EBV-CTL
  5. Patients who have received allogeneic stem cell transplantations
  6. Patients with severe or uncontrolled medical disorders(diabetes exceeding HbA1C9%, severe hypertension exceeding 180/110 mmHg, heart failure of NYHA class Ⅲ or Ⅳ, myocardial infarction diagnosed within 6 months prior to screening)
  7. Patients with apparent infection (HIV infection, chronic hepatitis B, chronic hepatitis C, active tuberculosis, etc.)
  8. Patients with malignant tumors or previous history of malignant tumors except completely recovered non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma
  9. Patients currently receiving treatment for ENKL such as chemotherapy, hormone therapy, or immunotherapy
  10. Patients with hypersensitivity to the investigational product or pretreatment products, including cryoprotectants

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): NCT03671850


Contacts
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Contact: Dae-Hee Sohn 82-70-4348-7527 goriest@vigencell.com
Contact: Hyun-Jung Sohn 82-70-4348-7527 sohnhj@vigencell.com

Locations
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Korea, Republic of
Inje University Busan Paik Hospital Recruiting
Busan, Korea, Republic of, 47392
Contact: Won-Sik Lee, M.D., Ph.D         
Keimyung University Daegu Dongsan Hospital Recruiting
Daegu, Korea, Republic of, 41931
Contact: YoungRok Do, M.D., Ph.D         
Hallym Univ. Medical Center Recruiting
Gyeonggi-do, Korea, Republic of, 14068
Contact: Hyo Jung Kim, M.D., Ph.D         
Chonnam National University Hwasun Hospital Recruiting
Hwasun, Korea, Republic of, 58128
Contact: Deok-Hwan Yang, M.D., Ph.D         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Inho Kim, M.D., Ph.D         
Severance Hospital Recruiting
Seoul, Korea, Republic of, 03722
Contact: Jinseok Kim, M.D., Ph.D         
Konkuk University Medical Center Recruiting
Seoul, Korea, Republic of, 05030
Contact: Sung-Yong Kim, M.D., Ph.D         
Seoul St.Mary`s Hospital Recruiting
Seoul, Korea, Republic of, KS013
Contact: Seok-Goo Cho, M.D., Ph.D)         
Sponsors and Collaborators
ViGenCell Inc.
Investigators
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Principal Investigator: Seok-Goo Cho The Catholic University of Korea
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Responsible Party: ViGenCell Inc.
ClinicalTrials.gov Identifier: NCT03671850    
Other Study ID Numbers: VT-EBV-201
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, Extranodal NK-T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin