None listed
Conditions
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients matching all of the following were included: 1)Histologically verified PTLD patient according to the World Health Organization (WHO) classification 2) Patients who showed response to conventional therapy of PTLD, including reduction of immunosuppression, chemotherapy, surgery, and/or radiotherapy 3)Patients who are at least 14 years old up to 74 years old 4) Eastern Cooperative Oncology Group (ECOG) performance rating of 0, 1, 2 5) Patients with adequate kidney function (serum creatinine less than 1.5 times the normal upper limit) 6) Patients with adequate liver function (bilirubin less than 1.5 times the normal upper limit in the serum) 7) Patients with adequate heart function (there should be no specific electrocardiographic findings according to the principal investigator's judgment) 8) No evidence of secondary tumor, heart failure, infection chronic lung disease ultimately according to the principal investigator's judgment. 9) Voluntarily signed the informed patient consent
Exclusion criteria
Exclusion criteria: Patients with any of the following were excluded from the study: 1) Pregnancy, lactation or potential of pregnancy 2) Bacterial or fungal infection of unknown cause or patients with fever (=38?) or active infection in progress 3) Patients under 14 years old or over 75 years old 4) Eastern Cooperative Oncology Group (ECOG) performance rating of 3, 4 5) Previously demonstrated human immunodeficiency virus (HIV) infection, hypertension (diastolic blood pressure >115mmHg), unstable angina, congestive heart failure (NY class II or higher), severe diabetes that is not well controlled, coronary angioplasty within the last 6 months, patients with acute myocardial infarction or non-malignant diseases including atrial ventricular arrhythima within the past six months 6)Patients with a mental disorder or substance abuse that is considered to affect the results of the research 7) Patients participating in another clinical trial 8) Patients with other serious medical conditions. 9) Patients who did not achieve complete response following inital therapy, including chemotherapy and/or radiotherapy, salvage therapy, or high-dose therapy and stem cell transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We determined the safety of administered EBV-specific CTLs following treatment.;We determined the efficacy of administered EBV-specific CTLs following treatment for two years to determine the disease-free survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| We determined the changes in immune response following EBV-specfic CTL administration by detecting the plasma EBV DNA levels.;We determined the efficacy of administered EBV-specific CTLs following treatment for two years to determine the progression-free survival | — |
Countries
Korea, Republic of
Contacts
Public ContactNayoun Kim
The Catholic University of Korea
Outcome results
None listed