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

Diffuse Large B-cell Lymphoma Clinical Trial

— NKCell  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00846157
• Other study ID #: NKMGI 4-06
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: February 15, 2009
• Last updated: June 26, 2011
• Start date: September 2007
• Est. completion date: September 2014

Study information

• Verified date: February 2009
• Source: NKBio Co.Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 276
• Est. completion date: September 2014
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 ?, ?, ?, ?

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Biological:
• NKM injection
NKCell about 100mg IV for 6times in each chemotherapy period.

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of korea	Banpo-Dong 505	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
NKBio Co.Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event Free survival		3 years	No
Secondary	Progression free survival		3 years	No