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

Sponsor
Sandoz
Study ID
NCT01419665
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GP2013 — BIOLOGICAL
    Type: Biological/Vaccine
  • rituximab — BIOLOGICAL
    Type: Biological/Vaccine

Study Details

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.

Key Dates

Start date
Dec 1, 2011
Status verified
Apr 2021
Primary completion
Jul 10, 2015
Completion
Jan 22, 2018

Study Design

Enrollment
629 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GP2013
    Type: Biological/Vaccine
  • Active Comparator: rituximab
    Type: Biological/Vaccine

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: 24 weeks ]

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