NCT00825149

A Study of Obinutuzumab in Combination With Chemotherapy in Participants With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma

An Open-Label, Multi-Centre, Randomised, Phase Ib Study to Investigate the Safety and Efficacy of RO5072759 Given in Combination With CHOP, FC or Bendamustine Chemotherapy in Patients With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open-label, randomized, phase Ib study will assess the safety and efficacy of obinutuzumab given in combination with FC (fludarabine and cyclophosphamide) or CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) or bendamustine induction chemotherapy in participants with Cluster of Differentiation (CD) 20+ B-cell Follicular Lymphoma (FL). Participants with complete response or partial response after induction therapy may receive maintenance therapy every 3 months for 2 years or until disease progression, whichever comes first. All participants in the induction period of the study will have a safety follow-up visit 28 days after completing the last dose of obinutuzumab + chemotherapy, and will be followed for at least 2 years, unless they are being treated in maintenance or discontinue from the study prior to this time point. Participants who complete/discontinue maintenance therapy will also be followed for a period of 2 years after receiving the last dose of obinutuzumab or until progression/new antilymphoma treatment.

Conditions

• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Bendamustine	Bendamustine will be administered as per schedule specified in the respective arm.
DRUG	Cyclophosphamide	Cyclophosphamide will be administered as per schedule specified in the respective arm.
DRUG	Doxorubicin	Doxorubicin will be administered as per schedule specified in the respective arm.
DRUG	Fludarabine	Fludarabine will be administered as per schedule specified in the respective arm.
DRUG	Obinutuzumab	Obinutuzumab will be administered as per schedule specified in the respective arm.
DRUG	Prednisone	Prednisone will be administered as per schedule specified in the respective arm.
DRUG	Vincristine	Vincristine will be administered as per schedule specified in the respective arm.

Timeline

• Start date: 2009-02-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2009-01-19
• Last updated: 2016-11-04

Locations

34 sites across 6 countries: Australia, France, Germany, Italy, Spain, United Kingdom