MedTrace Logo

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

NCT01419665 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 629

Last updated 2021-05-14

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

BIOLOGICAL

GP2013

Type: Biological/Vaccine

BIOLOGICAL

rituximab

Type: Biological/Vaccine

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-01
Primary Completion
2015-07-10
Completion
2018-01-22

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01419665 on ClinicalTrials.gov