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SCCA Lymphoma Clinical Trials

GA101 for non-Hodgkin's Lymphoma (2388)
An open-label, multicenter, randomized, Phase III study to investigate the efficacy and safety of bendamustine compared with bendamustine + GA101, a monoclonal anti-CD20 antibody (also known as obinutuzumab or RO5072759), in patients with rituximab-refractory, indolent non-Hodgkin's lymphoma
Status Conditions Phase Study ID
Recruiting Non-Hodgkin's Lymphoma (NHL) Phase III 2388
NCT01059630
Summary

This is an open-label, multicenter, randomized, Phase III study to investigate the efficacy and safety of GA101 combined with bendamustine compared with bendamustine alone in patients with rituximab-refractory, indolent Non-Hodgkin's lymphoma (NHL).


Investigator
Oliver Press, MD, PhD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of histologically documented, CD20+, indolent NHL
  • Refractory to any previous regimen containing rituximab
  • Previously treated with a maximum of three unique chemotherapy containing treatment regimens
  • All patients must have at least one bi-dimensionally measurable lesion (>1.5 cm in its largest dimension by CT scan)

Exclusion Criteria:

  • Prior use of any monoclonal antibody (other than anti-CD20) within 3 months
  • Chemotherapy or other investigational therapy within 28 days
  • Prior treatment with bendamustine within 1 year
  • Prior allogeneic stem cell transplant
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (e.g., patients in whom re-dosing with rituximab would be contraindicated for safety reasons)
  • History of sensitivity to mannitol
  • Central nervous system lymphoma or histological evidence of transformation to high grade or diffuse large B-cell lymphoma
  • History of other malignancy that could affect compliance with the protocol or interpretation of results
  • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 4 weeks
  • Vaccination with a live vaccine a minimum of 28 days prior to randomization
  • Recent major surgery (within 4 weeks), other than for diagnosis
  • Presence of positive test results for Hepatitis B or Hepatitis C
  • Known history of HIV seropositive status
  • Positive test results for human T-lymphotropic virus type I (HTLV 1) virus in endemic countries
  • Women who are pregnant or lactating
  • Agreement to use an effective form of contraception for the duration of the study
  • Ongoing corticosteroid use >30 mg/day prednisone or equivalent
Last Updated
July 25, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.