Overview

This trial is active, not recruiting.

Condition follicular lymphoma
Treatments gp2013, rituximab
Phase phase 3
Target CD20
Sponsor Sandoz
Collaborator Novartis Pharmaceuticals
Start date December 2011
End date December 2017
Trial size 618 participants
Trial identifier NCT01419665, 2010-019522-13, GP13-301

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Type: Biological/Vaccine
gp2013 no brand name available
Type: Biological/Vaccine
(Active Comparator)
Type: Biological/Vaccine
rituximab MabThera(R)
Type: Biological/Vaccine

Primary Outcomes

Measure
Overall response rate in patients with FL
time frame: 24 weeks

Secondary Outcomes

Measure
Percentage of patients with Adverse Events (AEs)
time frame: up to 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient with previously untreated advanced stage, CD20-positive FL - Patient with ECOG performance status 0, 1 or 2. Exclusion Criteria: - Patient with Grade 3b (aggressive) FL or any histology other than FL grade 1, 2 or 3a - Patient who has previously received any prior therapy for lymphoma - Patient with evidence of any uncontrolled, active infection (viral, bacterial or fungal). - Patient with any malignancy within 5 years prior to date of randomization, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer. Other protocol-defined inclusion/exclusion criteria may apply

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Sandoz.