Biocell Natural Killer Mixture in Diffuse Large B Cell Lymphoma (DLBCL) Patients

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Diffuse Large B-cell Lymphoma

Intervention / Treatment
-----------------
* Biological: NKM injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women of the age between 20 and 70 The patients who have measurable lesion using radiograph and have not received chemotherapy and radiation therapy after confirming DCBCL. The patients with Ann arbor Ⅰ, Ⅱ, Ⅲ, Ⅳ The patients who have not received NK / T-Cell lymphocyte therapy. The patients who are expected to survive for at least 3 months. The patients who or whose representative voluntary have written informed consent before performance of any study-related procedure. 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. The patients with ADL classification (ECOG) scale 0, 1, 2 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 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) The patients with negative HIV surface antigen The patients with negative HBV The patients with negative HCV The patients who have not received immunotherapy. The patients who have not experienced tuberculosis infection within recent 6 months. Exclusion Criteria: The minors under 20 years of age (In accordance with Civil Code) The patients diagnosed with other types of lymphoma The patients who have central nervous system or meningeal involvement by lymphoma. The patients who have contraindication of chemotherapy regimen The patients with another active severe disease. The patients who have history of cancer within 5 years Uncontrolled hypertension patients The patients who have hypersensitivity to Erythropoietin. 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 The patients who have experience to be treated with the pharmaceutical for clinical trials. Pregnant and lactating women or women of childbearing age not using adequate contraceptive method. The patients with clinically serious bacterial, viral or fungal infection 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) Patients with autoimmune diseases The patients who underwent visceral resection related with Lymphoma.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>Rituximab 375mg/m2 IV administered on day 1. Cyclophosphamide 750mg/m2 IV for 2hours,Adriamycin 50mg/m2 ,Vincristine 1.4mg/m2 IV respectively. Prednisone 60mg P.O. per day for 5 days. | |
| Active Comparator: Active<br>R-CHOP plus Natural Killer Cell therapy | Biological: NKM injection<br>* NKCell about 100mg IV for 6times in each chemotherapy period.<br>* Other names: NKCell;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event Free survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
natural killer cell, DLBCL (Diffuse Large B Cell Lymphoma)