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NCT03814785 Clinical Trial

GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)

Follicular Lymphoma Clinical Trial

— ASSIST_FL  

Official title:
A Randomized, Controlled, Double-Blind Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of GP2013 vs. MabThera® in Patients With Previously Untreated, Advanced Stage Follicular Lymphoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03814785
Other study ID # GP13-301
Secondary ID 2010-019522-13
Status Completed
Phase Phase 3
First received
Last updated
Start date December 1, 2011
Est. completion date January 22, 2018

Study information
Verified date January 2019
Source Sandoz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate comparability of the ORR in patients with previously untreated, advanced stage FL who receive GP2013-treatment to patients who receive MabThera-treatment.

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Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• GP2013
Type: Biological/Vaccine
• rituximab
Type: Biological/Vaccine
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Sponsors (2)
Lead Sponsor Collaborator
Sandoz Novartis Pharmaceuticals

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Brazil,  Bulgaria,  Colombia,  France,  Germany,  Greece,  Hungary,  India,  Ireland,  Israel,  Italy,  Japan,  Malaysia,  Netherlands,  Peru,  Poland,  Portugal,  Romania,  Russian Federation,  South Africa,  Spain,  Ukraine,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall response rate in patients with FL Overall response rate 24 weeks
Secondary Percentage of patients with Adverse Events (AEs) up to 2 years
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