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A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN)

NCT01059630 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 413

Last updated 2020-01-13

Study results available
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Summary

This open-label, multicenter, randomized Phase III study will investigate the efficacy, safety, pharmacokinetics and pharmacoeconomics of obinutuzumab (RO5072759, GA101) combined with bendamustine followed by continued obinutuzumab treatment (maintenance monotherapy) compared with bendamustine alone treatment in participants with rituximab-refractory indolent Non-Hodgkin's lymphoma (iNHL). The end of study was defined to when safety follow-up for all patients had been completed (2 years' safety follow-up from last dose).

Conditions

  • Non-Hodgkin's Lymphoma

Interventions

DRUG

Obinutuzumab

IV infusion.

DRUG

Bendamustine

IV infusion.

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Genentech, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2014-09-30
Completion
2018-11-30

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Italy
  • Netherlands
  • Russia
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

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 NCT01059630 on ClinicalTrials.gov