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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by NKBio Co.Ltd..
Recruitment status was:  Enrolling by invitation
Information provided by:
NKBio Co.Ltd. Identifier:
First received: February 15, 2009
Last updated: June 26, 2011
Last verified: February 2009

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.

Condition Intervention Phase
Diffuse Large B-cell Lymphoma Biological: NKM injection Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by NKBio Co.Ltd.:

Primary Outcome Measures:
  • Event Free survival [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: 3 years ]

Estimated Enrollment: 276
Study Start Date: September 2007
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: NKCell


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00846157

Korea, Republic of
The Catholic University of korea
Banpo-Dong 505, Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
NKBio Co.Ltd.
Principal Investigator: Seok-Goo Cho, MD,PhD Catholic Hematopoietic Stem Cell Transplantation Center in The Catholic University of Korea
  More Information

Responsible Party: Lee,Jae-Kyu, Bio Bisiness Headquater/Assistant Manager in Cell Manufacture Team Identifier: NCT00846157     History of Changes
Other Study ID Numbers: NKMGI 4-06
Study First Received: February 15, 2009
Last Updated: June 26, 2011

Keywords provided by NKBio Co.Ltd.:
natural killer cell
DLBCL (Diffuse Large B Cell Lymphoma)

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin processed this record on August 18, 2017