Study of Mini-Chop Plus Ofatumumab To Treat Cd 20+ Diffuse Large B-Cell Lymphoma In Patients Aged Over 80 Years
This study is a multicentric, phase II, open-label, non-randomized trial evaluating the efficacy of O-miniCHOP in patients aged over 80 years with non previously treated CD20+ diffuse large B-cell lymphoma (age-adjusted IPI=0 to3), stage I, II, III or IV with a performance status ECOG from 0 to 4.
The anticipated study dates (start / end) are: 2010 - 2013. The study will evaluate a cohort of 120 patients (approximately 95 in France, 15 in Belgium, 5 in Switzerland and 5 in Portugal).
Patients will be recruited over 30 months and followed at least one year after the last patient has been included.
The duration of the treatment period is approximately 20 weeks.
Non Previously Treated CD20+ Diffuse Large B-cell Lymphoma
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||PHASE II STUDY OF MINI-CHOP PLUS OFATUMUMAB (O) IN NON PREVIOUSLY TREATED PATIENTS AGED OVER 80 YEARS WITH CD 20+ DIFFUSE LARGE B-CELL LYMPHOMA|
- Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2010|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
solution for perfusion, 1000mg per cycle, 1 cycle every 3 weeks, total 6 cycles
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195714
Show 84 Study Locations
|Study Chair:||Peyrade Frederic, MD||Lymphoma Study Association|