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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


Phase 3
20 Years
70 Years
Open (Enrolling by invite only)
Both
Diffuse Large B-cell Lymphoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Event Free survival

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Seok-Goo Cho, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

NKMGI 4-06

NCT ID:

NCT00846157

Start Date:

September 2007

Completion Date:

September 2014

Related Keywords:

  • Diffuse Large B-Cell Lymphoma
  • natural killer cell
  • DLBCL (Diffuse Large B Cell Lymphoma)
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

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