None listed
Conditions
Interventions
Drug, Biological/Vaccine, Non-Stem Cell : Rituximab + autologous CIKcells
1. Rituximab treatment
1) Dose: Mix in 500mL of normal saline and inject 375mg/? intravenously
2) Administration route:
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients over 65 years of age 2) Elderly DLBCL patients with complete response (CR) to the first-line R-CHOP therapy 3) Patients whose LDH level is higher than the normal range for each laboratory at the time of initial diagnosis 4) Ann arbor Advanced stage (stage III, IV) or bulky disease 5) ECOG performance evaluation 0, 1, 2 factors 6) Patients within 6 months of receiving the first R-CHOP therapy 7) Those who are judged to be able to survive more than 3 months 8) Patients who satisfy the following in the blood test 9) White blood cell count = 3.0 109/L (103/uL) 10) Platelet count = 750/109/L (103/uL) 11) Total bilirubin in serum = 2 times the normal upper limit of each laboratory 12) Serum liver enzyme levels (transaminases, AST, ALT) = 3 times the normal upper limit of each laboratory 13) Patients who did not receive other immunotherapy 14) Patients without tuberculosis infection within 6 months 15) Those who agree to participate in this clinical trial and have consented in writing
Exclusion criteria
Exclusion criteria: 1) Pregnant, lactating or pregnant women or women who have not taken adequate contraceptive measures 2) For men who are sexually active with women of childbearing age, men who do not take appropriate contraception (a double-blocking method that uses a male condom and a cervical cap or under a contraceptive diaphragm and additional spermicide) 3) Patients with active infection or fever (= 38?) of unknown etiology or ongoing bacterial or fungal infection 4) HIV, HBV, HCV positive patients 5) Subjects with cancer history within 5 years 6) Uncontrolled hypertension (diastolic blood pressure> 115 mmHg) 7) unstable angina or congestive heart failure (NY class II or higher) 8) Severe diabetes that is poorly controlled 9) Those who have undergone coronary angioplasty within the last 6 months 10) Patients with non-malignant diseases including acute myocardial infarction or uncontrolled atrial or ventricular arrhythmia within the last 6 months 11) Mental disorder patients, drug addiction 12) Those who participated in other clinical trials within 30 days before registration 13) Those who judge that the investigator is unsuitable for participation in the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 year disease free survival;Incidence of adverse reactions of NCI grade 3 or higher | — |
Secondary
| Measure | Time frame |
|---|---|
| 2 year progression free survival;Tumor response (complete response or partial response) | — |
Countries
Korea, Republic of
Contacts
Public ContactNayoun Kim
LucasBio
Outcome results
None listed