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Biocell Natural Killer Mixture in Diffuse Large B Cell Lymphoma (DLBCL) Patients (NKCell)
This study is enrolling participants by invitation only.
First Received: February 15, 2009   Last Updated: March 3, 2009   History of Changes
Sponsored by: NKBio Co.Ltd.
Information provided by: NKBio Co.Ltd.
ClinicalTrials.gov Identifier: NCT00846157
  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 III

MedlinePlus related topics: Lymphoma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
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

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: 260
Study Start Date: September 2007
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
control: No Intervention

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: Active Comparator
R-CHOP plus Natural Killer Cell therapy
Biological: NKM injection
NKCell about 100mg IV for 6times in each chemotherapy period.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of Diffuse large B Cell Lymphoma patients
  • Have not been treated by any chemotherapy or radiotherapy.
  • Radiologically measurable lesion
  • Have not been experienced by NKCell or other biocell therapy

Exclusion Criteria:

  • other type Lymphoma
  • High LDH and ANN arbor stage III or IV.
  • Central nervouse system or meningeal involvement by lymphoma
  • contradiction of R-CHOP regimen
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Quality Assurance Team Manager ( Choi Byeong-In )
Study ID Numbers: NKMGI 4-04
Study First Received: February 15, 2009
Last Updated: March 3, 2009
ClinicalTrials.gov Identifier: NCT00846157     History of Changes
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)

Study placed in the following topic categories:
Lymphoma, B-Cell
Lymphatic Diseases
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
B-cell Lymphomas
 Lymphoma, Large-cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

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

ClinicalTrials.gov processed this record on May 07, 2009



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