NCT01659099

GA In NEwly Diagnosed Diffuse Large B Cell Lymphoma

Randomized Phase III Study Using a Pet-driven Strategy and Comparing GA101 OR Rituximab Associated to a Chemotherapy Delivered Every 14 Days (ACVBP or CHOP) in DLBCL CD20+ Lymphoma Untreated Patients From 18 to 60 Presenting With 1 or More Adverse Prognostic Factors of the Age-adjusted IPI

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 671 (actual)
• Sponsor: The Lymphoma Academic Research Organisation · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to investigate: * the interest of a new monoclonal antibody (GA101)versus rituximab * the interest of PET to identify early responders Patients will receive either rituximab (standard treatment), either GA101 (study treatment), according to the randomization arm. The monoclonal antibody will be associated to a chemotherapy: CHOP or ACVBP according to site's choice.A PET scan will be done before inclusion, after 2 chemotherapy cycles, and after 4 chemotherapy cycles, to identify early patients responders, for who consolidation with ASCT is not required.

Conditions

• Diffuse Large B Cell Lymphoma CD20 Positive

Interventions

Type	Name	Description
DRUG	GA101	in GA-ACBVP or in GA-CHOP 1000 mg on D1 and D8 (D8 in cycle 1 and 2)
DRUG	Rituximab	in R-ACBVP or in R-CHOP 375 mg/m² on D1
DRUG	Doxorubicin	in ACBVP : 75 mg/m² on D1 in CHOP : 50 mg/m² on D1
DRUG	Cyclophosphamide	in ACBVP : 1200 mg/m² on D1 in CHOP : 750 mg/m² on D1
DRUG	Prednisone	in ACBVP : 60 mg/m² from D1 to D5 in CHOP : 40 mg/m² from D1 to D5
DRUG	Bleomycin	in ACBVP 10 mg from D1 to D5
DRUG	Vindesin	in ACBVP 2 mg/m² from D1 to D5
DRUG	Vincristine	in CHOP 1,4 mg/m² on D1

Timeline

• Start date: 2012-09-01
• Primary completion: 2016-08-01
• Completion: 2017-12-31
• First posted: 2012-08-07
• Last updated: 2018-03-07

Locations

122 sites across 2 countries: Belgium, France