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

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

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.

Study Overview

• Status: Unknown
• Conditions: Diffuse Large B-cell Lymphoma
• Intervention / Treatment: Biological: NKM injection

• Study Type: Interventional
• Enrollment (Anticipated): 276
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul
    • Banpo-Dong 505, Seoul, Korea, Republic of, 137-701
      • The Catholic University of Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control; 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; R-CHOP plus Natural Killer Cell therapy	Biological: NKM injection; NKCell about 100mg IV for 6times in each chemotherapy period.; Other Names: NKCell

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Event Free survival	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression free survival	3 years

Collaborators and Investigators

• Sponsor: NKBio Co.Ltd.
• Investigators: Principal Investigator: Seok-Goo Cho, MD,PhD, Catholic Hematopoietic Stem Cell Transplantation Center in The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Anticipated): September 1, 2011
• Study Completion (Anticipated): September 1, 2014

Study Registration Dates

• First Submitted: February 15, 2009
• First Submitted That Met QC Criteria: February 17, 2009
• First Posted (Estimate): February 18, 2009

Study Record Updates

• Last Update Posted (Estimate): June 28, 2011
• Last Update Submitted That Met QC Criteria: June 26, 2011
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: natural killer cell; DLBCL (Diffuse Large B Cell Lymphoma)
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: NKMGI 4-06