Diffuse Large B-cell Lymphoma
Conditions
Keywords
natural killer cell, DLBCL (Diffuse Large B Cell Lymphoma)
Brief summary
Primary objective: * To compare the event free survival for 3years of R-CHOP plus Biocell Natural Killer Cell to R-CHOP therapy with DLBCL patients.
Interventions
BIOLOGICALNKM injection
NKCell about 100mg IV for 6times in each chemotherapy period.
Sponsors
NKBio Co.Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
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 treatment. 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 laboratory * serum creatinine ≤ two times of upper limit of normal values of each laboratory 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.
Exclusion criteria
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 trials. 11. Pregnant and lactating women or women of childbearing age not using adequate contraceptive method. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event Free survival | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival | 3 years |
Countries
South Korea
Outcome results
None listed