GAUSS: A Study of RO5072759 in Patients With Indolent Non-Hodgkin's Lymphoma - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00576758

Purpose

This study will investigate the efficacy of weekly intravenous GA101 (RO5072759) monotherapy, in patients with relapsed CD20+ indolent Non-Hodgkin's Lymphoma. Patients will be randomized to receive either GA101 or rituximab, given as four weekly infusions. At the conclusion of the initial trial patients may be eligible to continue therapy up to 24 months. The anticipated time on study treatment is 3- 24 months, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Non-Hodgkin's Lymphoma	Drug: RO5072759 Drug: rituximab	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-label, Multi-center, Randomized Study to Evaluate the Efficacy on Tumor Response of GA101 (RO5072759) Monotherapy Versus Rituximab Monotherapy in Patients With Relapsed CD20+ Indolent Non-Hodgkin's Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Rituximab

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Phase 2: Overall response rate [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Complete and partial response rates, progression-free survival, event-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Adverse events, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	196
Study Start Date:	January 2008
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: RO5072759 intravenous dose
Active Comparator: 2	Drug: rituximab 375mg/m2 weekly

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients, >=18 years of age
relapsed CD20+ indolent B-cell non-Hodgkin's lymphoma
documented history of response of >/= 6 months duration from last rituximab-containing regimen
clinical indication for treatment as determined by the investigator
ECOG performance status 0-2

Exclusion Criteria:

prior use of any investigational monoclonal antibody within 6 months of study start
prior use of any anti-cancer vaccine
prior use of rituximab within 8 weeks of study entry
radioimmunotherapy within 3 months prior to study entry
CNS lymphoma or evidence of transformation to high-grade or diffuse large B-cell lymphoma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576758

Show 72 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00576758 History of Changes
Other Study ID Numbers:	BO21003
Study First Received:	December 18, 2007
Last Updated:	January 17, 2012
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012