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