Conditions: Diffuse Large B-Cell Lymphoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 143
Healthy volunteers: no

Brief 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.

Arms:
arm 1: A course of MabionCD20 consists of intravenous infusions in dose 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles.

Intervention: Drug: Rituximab arm 2: A course of MabThera consists of intravenous infusions in dose 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles.

Intervention: Drug: Rituximab

Interventions: intervention 1: Rituximab intervention 2: Doxorubicin intervention 3: Vincristine intervention 4: Cyclophosphamide intervention 5: prednisone
Intervention descriptions: intervention 1: 375 mg/m2 IV on day 1 of each 21 days chemotherapy cycle. Number of Cycles: 8. intervention 2: 50 mg of doxorubicin per square meter administrated IV on day 1 of each chemotherapy cycle intervention 3: 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 intervention 4: 750 mg of cyclophosphamide per square meter of body-surface area administrated IV on day 1 of each chemotherapy cycle intervention 5: 100 mg of prednisone administrated PO per day for five days, day 1-5 of each chemotherapy cycle

Protocol document:
Prot_000.pdf: 


















































































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SAP_001.pdf: