Study of Mini-Chop Plus Ofatumumab To Treat Cd 20+ Diffuse Large B-Cell Lymphoma In Patients Aged Over 80 Years
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|ClinicalTrials.gov Identifier: NCT01195714|
Recruitment Status : Completed
First Posted : September 6, 2010
Last Update Posted : March 7, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Non Previously Treated CD20+ Diffuse Large B-cell Lymphoma||Drug: Ofatumumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
solution for perfusion, 1000mg per cycle, 1 cycle every 3 weeks, total 6 cycles
- Overall Survival [ Time Frame: 2 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): NCT01195714
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|Study Chair:||Peyrade Frederic, MD||Lymphoma Study Association|