Last updated: April 28, 2022
Sponsor: ViGenCell Inc.
Overall Status: Active - Recruiting
Phase
2
Condition
Lymphoma
T-cell Lymphoma
Lymphoproliferative Disorders
Treatment
N/AClinical Study ID
NCT03671850
VT-EBV-201
Ages 19-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- EBV positive extranodal NK/T cell lymphoma (ENKL) patients pathologically confirmedaccording to WHO classification at first diagnosis
- Patients whose complete remission (CR) has been confirmed within 6 months beforescreening and maintained, presenting high risk of relapse due to one or more of thefollowing 1) Patients who are EBV detectable at initial diagnosis, with one or more ofthe 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 greaterremission induction therapy after the failure of primary remission induction, orachieved remission after relapse
- 19 years and above to 75 years and below
- Patients with ECOG performance criteria score of 0 to 2
- Patients with acceptable hematopoietic function (ANC ≥ 1.5 x 109 /L, PLT ≥ 100 x 109 /L, Hb ≥ 9 g/dL)
- Patients with acceptable liver function (total bilirubin < 2 x upper limit of normal,AST/ALT < 3 x upper limit of normal)
- Patients with renal function of eGFR > 50 or better
- Patients with life expectancy of 6 or longer
- Patients who have agreed to use two different types of birth control during the studyperiod (Females of childbearing age or within 2 years after menopause have to shownegative results in urine pregnancy test) (E.g., dual contraception using oralcontraceptives, contraceptive implant, contraceptive injection, or contraceptive patchcombined with intrauterine device, spermicide foam or gel, contraceptive film, vaginaldiaphragm, cervical cap, condom, etc.)
- Patients who have voluntarily given written consent to participate in this study
Exclusion
Exclusion Criteria:
- Other pathological classifications of nasal cavity lymphoma than ENKL at initialdiagnosis
- Patients with ENKL that has invaded the central nervous system
- Patients in PR, SD or PD state, not complete remission (CR)
- Patients who cannot generate EBV-CTL
- Patients who have received allogeneic stem cell transplantations
- 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)
- Patients with apparent infection (HIV infection, chronic hepatitis B, chronichepatitis C, active tuberculosis, etc.)
- Patients with malignant tumors or previous history of malignant tumors exceptcompletely recovered non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma
- Patients currently receiving treatment for ENKL such as chemotherapy, hormone therapy,or immunotherapy
- Patients with hypersensitivity to the investigational product or pretreatmentproducts, including cryoprotectants
Study Design
Total Participants: 48
Study Start date:
April 09, 2019
Estimated Completion Date:
June 03, 2024
Study Description
Connect with a study center
Inje University Busan Paik Hospital
Busan, 47392
Korea, Republic ofActive - Recruiting
Keimyung University Daegu Dongsan Hospital
Daegu, 41931
Korea, Republic ofActive - Recruiting
Hallym Univ. Medical Center
Gyeonggi-do, 14068
Korea, Republic ofActive - Recruiting
Chonnam National University Hwasun Hospital
Hwasun, 58128
Korea, Republic ofActive - Recruiting
Konkuk University Medical Center
Seoul, 05030
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofActive - Recruiting
Seoul St.Mary's Hospital
Seoul, KS013
Korea, Republic ofActive - Recruiting
Severance Hospital
Seoul, 03722
Korea, Republic ofActive - Recruiting
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