Clinical trial NCT00846157: Biocell Natural Killer Mixture in Diffuse Large B Cell Lymphoma (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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diffuse Large B-cell Lymphoma
Keywords: natural killer cell
DLBCL (Diffuse Large B Cell Lymphoma)
Lead sponsor: NKBio Co.Ltd.
Sponsor class: INDUSTRY
First posted: 2009-02-18
Enrollment: 276
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Event Free survival
timeFrame: 3 years
Secondary outcomes:
measure: Progression free survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Banpo-Dong 505
country: Korea, Republic of
facility: The Catholic University of korea
state: Seoul
Study officials:
affiliation: Catholic Hematopoietic Stem Cell Transplantation Center in The Catholic University of Korea
name: Seok-Goo Cho, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: