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||Drug: Ofatumumab||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
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 ]
|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|