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

NCT00825149 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2016-11-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Australia
  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT00825149 on ClinicalTrials.gov