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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00576758
First received: December 18, 2007
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  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 2

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: 197
Study Start Date: January 2008
Study Completion Date: March 2013
Primary Completion Date: March 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 71 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00576758     History of Changes
Other Study ID Numbers: BO21003
Study First Received: December 18, 2007
Last Updated: May 23, 2013
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 May 23, 2013