MabionCD20 Compared to MabThera in Lymphoma Patients

Sponsor
Mabion SA
Study ID
NCT02617485
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 31, 2015
Status verified
Jan 2023
Primary completion
Aug 31, 2017
Completion
Jan 31, 2018

Study Design

Enrollment
143 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MabionCD20
    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
  • Active Comparator: MabThera
    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

Primary Outcome Measure

Area Under the Serum Concentration-time Curve From Day 1 to Week 4 (AUC[1-4]) [ Time Frame: Baseline to Week 4 ]

Related Studies