A Phase I/II clinical trial to evaluate the safety and efficacy of combined maintenance of rituximab and cytokine-induced killer cells in elderly high-risk lymphoma patients responding to the first chemotherapy

Not Applicable

Conditions: Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism

Registration Number: KCT0005708

Lead Sponsor: The Catholic University of Korea, Seoul St. Mary's Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 36

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

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