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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
NKBio Co.Ltd.
ClinicalTrials.gov Identifier:
NCT00846157
First received: February 15, 2009
Last updated: June 26, 2011
Last verified: February 2009
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846157

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

No publications provided

Responsible Party: Lee,Jae-Kyu, Bio Bisiness Headquater/Assistant Manager in Cell Manufacture Team
ClinicalTrials.gov Identifier: NCT00846157     History of Changes
Other Study ID Numbers: NKMGI 4-06
Study First Received: February 15, 2009
Last Updated: June 26, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 29, 2014