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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.

Tracking Information
First Submitted Date  ICMJE February 15, 2009
First Posted Date  ICMJE February 18, 2009
Last Update Posted Date June 28, 2011
Study Start Date  ICMJE September 2007
Estimated Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2009)
Event Free survival [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2009)
Progression free survival [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Biocell Natural Killer Mixture in Diffuse Large B Cell Lymphoma (DLBCL) Patients
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diffuse Large B-cell Lymphoma
Intervention  ICMJE Biological: NKM injection
NKCell about 100mg IV for 6times in each chemotherapy period.
Other Name: NKCell
Study Arms  ICMJE
  • 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
    Intervention: Biological: NKM injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 26, 2011)
Original Estimated Enrollment  ICMJE
 (submitted: February 17, 2009)
Estimated Study Completion Date  ICMJE September 2014
Estimated Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00846157
Other Study ID Numbers  ICMJE NKMGI 4-06
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lee,Jae-Kyu, Bio Bisiness Headquater/Assistant Manager in Cell Manufacture Team
Study Sponsor  ICMJE NKBio Co.Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Seok-Goo Cho, MD,PhD Catholic Hematopoietic Stem Cell Transplantation Center in The Catholic University of Korea
PRS Account NKBio Co.Ltd.
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP