R-CHOP Therapy Compared With R-CHOP Plus Biocell Natural Killer Mixture in Patients With DLBCL (Diffuse Large B Cell Lymphoma);A Randomized, Open-label,Multi-center Trail
1. Men and women of the age between 20 and 70
2. The patients who have measurable lesion using radiograph and have not received
chemotherapy and radiation therapy after confirming DCBCL.
3. The patients with Ann arbor Ⅰ, Ⅱ, Ⅲ, Ⅳ
4. The patients who have not received NK / T-Cell lymphocyte therapy.
5. The patients who are expected to survive for at least 3 months.
6. The patients who or whose representative voluntary have written informed consent
before performance of any study-related procedure.
7. Women of child bearing potential must have a negative pregnancy test within 7 days
prior to study registration and agree to use adequate birth control during study
8. The patients with ADL classification (ECOG) scale 0, 1, 2
9. Patients who satisfy following hematologic criteria
- WBC ≥ 3,000 / ㎕
- platelet count ≥ 75,000 / ㎕
- serum total bilirubin ≤ two times of upper limit of normal values of each
- serum creatinine ≤ two times of upper limit of normal values of each
10. lymphoma patients who satisfy the following criteria
- good renal function (GFR> 50)
- good hepatic function (total bilirubin level ≤ three times of upper limit of
normal values of each test laboratory transaminases ≤ 5 times of the upper
limit of normal value of each testing laboratory)
11. The patients with negative HIV surface antigen
12. The patients with negative HBV
13. The patients with negative HCV
14. The patients who have not received immunotherapy.
15. The patients who have not experienced tuberculosis infection within recent 6 months.
1. The minors under 20 years of age (In accordance with Civil Code)
2. The patients diagnosed with other types of lymphoma
3. The patients who have central nervous system or meningeal involvement by lymphoma.
4. The patients who have contraindication of chemotherapy regimen
5. The patients with another active severe disease.
6. The patients who have history of cancer within 5 years
7. Uncontrolled hypertension patients
8. The patients who have hypersensitivity to Erythropoietin.
9. The patients who have the following diseases or the experience to have following
disease within 3 months.
- Myocardial infarction
- Unstable coronary disease
- Uncontrolled cardiac insufficiency.
- Venous thrombosis
- Pulmonary embolism
10. The patients who have experience to be treated with the pharmaceutical for clinical
11. Pregnant and lactating women or women of childbearing age not using adequate
12. The patients with clinically serious bacterial, viral or fungal infection
13. The patients of the test group who have the problem in NK cell cultures (Investigator
will decide on this criteria with basis generated during NK cell culture)
14. Patients with autoimmune diseases
15. The patients who underwent visceral resection related with Lymphoma.