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

NCT ID: NCT00846157

Last Updated: 2011-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2014-09-30

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.

Conditions

Diffuse Large B-cell Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Active

R-CHOP plus Natural Killer Cell therapy

Group Type: ACTIVE_COMPARATOR

NKM injection

Intervention Type: BIOLOGICAL

NKCell about 100mg IV for 6times in each chemotherapy period.

Interventions

NKM injection

NKCell about 100mg IV for 6times in each chemotherapy period.

Intervention Type: BIOLOGICAL

Other Intervention Names

NKCell

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NKBio Co.Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Bio Bisiness Headquater/Assistant Manager in Cell Manufacture Team

Principal Investigators

Seok-Goo Cho, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Catholic Hematopoietic Stem Cell Transplantation Center in The Catholic University of Korea

Locations

The Catholic University of korea

Banpo-dong, Seoul, South Korea

Countries

South Korea

Other Identifiers

NKMGI 4-06

Identifier Type: -

Identifier Source: org_study_id