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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00576758
First received: December 18, 2007
Last updated: May 7, 2013
Last verified: May 2013
History of Changes

December 18, 2007
May 7, 2013
January 2008
August 2013   (final data collection date for primary outcome measure)
Phase 2: Overall response rate [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Phase 1: Incidence of dose-limiting toxicity. Phase 2: Overall response rate.
Complete list of historical versions of study NCT00576758 on ClinicalTrials.gov Archive Site
  • 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 ]
Efficacy: Complete and partial response rates; progression-free survival, event-free survival, duration of response (Phase II only). Safety: AEs, laboratory parameters, Pk and Pd parameters.
Not Provided
Not Provided
 
GAUSS: A Study of RO5072759 in Patients With Indolent Non-Hodgkin's Lymphoma
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma
  • Drug: RO5072759
    intravenous dose
  • Drug: rituximab
    375mg/m2 weekly
  • Experimental: 1
    Intervention: Drug: RO5072759
  • Active Comparator: 2
    Intervention: Drug: rituximab
Sehn LH, Assouline SE, Stewart DA, Mangel J, Gascoyne RD, Fine G, Frances-Lasserre S, Carlile DJ, Crump M. A phase 1 study of obinutuzumab induction followed by 2 years of maintenance in patients with relapsed CD20-positive B-cell malignancies. Blood. 2012 May 31;119(22):5118-25. Epub 2012 Mar 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
197
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Austria,   Belgium,   Brazil,   Canada,   Croatia,   Denmark,   Greece,   Italy,   Netherlands,   Poland,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom
 
NCT00576758
BO21003
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP