NCT02617485

MabionCD20 Compared to MabThera in Lymphoma Patients

Randomized, Parallel-group, Double-blind, Comparative Bioequivalence Trial of MabionCD20 Compared to MabThera (Rituximab by Hoffman-La Roche) in Patients With Diffuse Large B-cell Lymphoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Mabion SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to demonstrate the high level of biosimilarity between MabionCD20 (MABION SA) and the reference product: MabThera (rituximab by Hoffman-La Roche) in patients with CD20-positive diffuse large B-cell lymphoma.

Detailed description

Patients who meet criteria for participation in this study receive 8 intravenous infusions of MabionCD20® or MabThera® 21 days interval in combination with standard dosage regimen of CHOP. The duration of the study is 12 months. The treatment and observation period will last 26 weeks starting from Day 1, until Week 26 - one month after last IMP infusion.

Conditions

• Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab	375 mg/m2 IV on day 1 of each 21 days chemotherapy cycle. Number of Cycles: 8.
DRUG	Doxorubicin	50 mg of doxorubicin per square meter administrated IV on day 1 of each chemotherapy cycle
DRUG	Vincristine	1.4 mg of vincristine per square meter, up to a maximal dose of 2 mg, administrated IV on day 1 of each chemotherapy cycle
DRUG	Cyclophosphamide	750 mg of cyclophosphamide per square meter of body-surface area administrated IV on day 1 of each chemotherapy cycle
DRUG	prednisone	100 mg of prednisone administrated PO per day for five days, day 1-5 of each chemotherapy cycle

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-08-01
• Completion: 2018-01-01
• First posted: 2015-12-01
• Last updated: 2023-10-25
• Results posted: 2023-10-25

Locations

35 sites across 7 countries: Bosnia and Herzegovina, Croatia, Georgia, Moldova, Poland, Serbia, Ukraine