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MabionCD20 Compared to MabThera in Lymphoma Patients

NCT02617485 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2023-10-25

Study results available
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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.

Conditions

  • Diffuse Large B-Cell Lymphoma

Interventions

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

Sponsors & Collaborators

  • Mabion SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-08-31
Completion
2018-01-31

Countries

  • Bosnia and Herzegovina
  • Croatia
  • Georgia
  • Moldova
  • Poland
  • Serbia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02617485 on ClinicalTrials.gov