Biocell Natural Killer Mixture in Diffuse Large B Cell Lymphoma (DLBCL) Patients (NKCell)
|ClinicalTrials.gov 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
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||276 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- Event Free survival [ Time Frame: 3 years ]
- Progression free survival [ Time Frame: 3 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00846157
|Korea, Republic of|
|The Catholic University of korea|
|Banpo-Dong 505, Seoul, Korea, Republic of, 137-701|
|Principal Investigator:||Seok-Goo Cho, MD,PhD||Catholic Hematopoietic Stem Cell Transplantation Center in The Catholic University of Korea|