CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 143 enrolled
Drug / intervention
Rituximab +4 moredrug
Likely dose
Rituximab 375 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02617485
NCT02617485Phase 3Completed
CompareCT.gov

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

Mabion SA·interventional·Posted Dec 1, 2015·Updated Oct 25, 2023

In Brief

A Phase 3 clinical trial evaluating Rituximab, Doxorubicin, and 3 other interventions for Diffuse Large B-Cell Lymphoma. Completed, enrolled 143 participants across 35 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiffuse Large B-Cell Lymphoma
CountriesBosnia and Herzegovina, Croatia, Georgia, Moldova, Poland, Serbia, Ukraine
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 1, 2015
Enrollment StartDec 1, 2015
Primary CompletionAug 1, 2017
Study CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.6 years ago

Interventions

Rituximabdrug

375 mg/m2 IV on day 1 of each 21 days chemotherapy cycle. Number of Cycles: 8.

Doxorubicindrug

50 mg of doxorubicin per square meter administrated IV on day 1 of each chemotherapy cycle

Vincristinedrug

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

Cyclophosphamidedrug

750 mg of cyclophosphamide per square meter of body-surface area administrated IV on day 1 of each chemotherapy cycle

prednisonedrug

100 mg of prednisone administrated PO per day for five days, day 1-5 of each chemotherapy cycle