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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00846157
Recruitment Status : Unknown
Verified February 2009 by NKBio Co.Ltd..
Recruitment status was:  Enrolling by invitation
First Posted : February 18, 2009
Last Update Posted : June 28, 2011
Information provided by:
NKBio Co.Ltd.

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.

Condition or disease Intervention/treatment Phase
Diffuse Large B-cell Lymphoma Biological: NKM injection Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 participants
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
Study Start Date : September 2007
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00846157

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Korea, Republic of
The Catholic University of korea
Banpo-Dong 505, Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
NKBio Co.Ltd.
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Principal Investigator: Seok-Goo Cho, MD,PhD Catholic Hematopoietic Stem Cell Transplantation Center in The Catholic University of Korea
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Responsible Party: Lee,Jae-Kyu, Bio Bisiness Headquater/Assistant Manager in Cell Manufacture Team Identifier: NCT00846157    
Other Study ID Numbers: NKMGI 4-06
First Posted: February 18, 2009    Key Record Dates
Last Update Posted: June 28, 2011
Last Verified: February 2009
Keywords provided by NKBio Co.Ltd.:
natural killer cell
DLBCL (Diffuse Large B Cell Lymphoma)
Additional relevant MeSH terms:
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Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin