NCT01195714

Study of Mini-Chop Plus Ofatumumab To Treat Cd 20+ Diffuse Large B-Cell Lymphoma In Patients Aged Over 80 Years

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: The Lymphoma Academic Research Organisation · Academic / Other
• Sex: All
• Age: 81 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non Previously Treated CD20+ Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Ofatumumab	solution for perfusion, 1000mg per cycle, 1 cycle every 3 weeks, total 6 cycles

Timeline

• Start date: 2010-05-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2010-09-06
• Last updated: 2018-03-07

Locations

84 sites across 2 countries: Belgium, France