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A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+RO5072759 (GA101) in Patients With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN)

Complete title: An Open-label, Multi-Center, Randomized, Phase III Study to Investigate the Efficacy and Safety of Bendamustine Compared with Bendamustine + GA101 (RO5072759) in Patients with Rituximab-Refractory, Indolent Non-Hodgkin’s Lymphoma (NHL) Genentech Inc. / Protocol GA04753g

Research Study Number       2388.00
    
Principal Investigator       Oliver Press, MD, PhD
    
Phase       III

Look up trial at NIH

Research Study Description

This open-label, multicenter, randomized, Phase III study will investigate the efficacy and safety of RO5072759 (GA101) combined with bendamustine compared with bendamustine alone in patients with rituximab-refractory, indolent Non-Hodgkin's lymphoma (NHL). Patients will be randomized to receive a maximum of 6 cycles of GA101 (1000mg iv infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2 - 6) and then every 2 months until disease progression for up to 2 years plus bendamustine (90 mg/m2 IV, on days 2 and 3 of cycle 1 and days 1 and 2 of cycles 2 - 6) on 28 day cycles or a maximum of 6 cycles of bendamustine alone (120 mg/m2 IV, on days 1 and 2 of cycles 1 - 6) on 28 day cycles.

Eligibility Criteria (must meet the following to participate in this study)

** For Eligibility information, please click on the "Look up trial at NIH" link above. **

Other eligibility criteria may apply.



Research Study Number       2388.00
    
Contact       Seattle Cancer Care Alliance Intake Office
    
Telephone       800-804-8824 / 206-288-1024
    
   

Keywords
Hematologic Malignancies; Lymphoma; Non-Hodgkin's Lymphoma (NHL)

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