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Clinical Trial Summary

The objective of this study is to test the efficacy and toxicity of a combined OBINUTUZUMAB/bendamustine therapy or single agent OBINUTUZUMAB in younger (< 60 years) medically non-fit, 'compromised' patients and in all older patients (≥ 60 years). For the assessment of the antilymphoma activity the overall response rate (ORR)" will be applied as primary endpoint. Overall response is defined as complete or partial response after 19 - 21 weeks.


Clinical Trial Description

Study design: This is a randomized, open-label, multicenter phase II trial with a parallel-group design of two groups. Randomization and Interventions: Randomization between Obinutuzumab single agent treatment versus Obinutuzumab plus Bendamustine followed by Obinutuzumab Treatment plans: Arm A: Obinutuzumab single agent Obinutuzumab flat dose of 1000 mg on Day 1 of each of four 28 -day cycles and on Days 8 and 15 of Cycle 1 If at least 'stable disease': Obinutuzumab flat dose of 1000 mg at weeks 21, 29, 37 and 45 Arm B: Obinutuzumab plus Bendamustine Obinutuzumab flat dose of 1000 mg on Day 1 of each of four 28 -day cycles and on Days 8 and 15 of Cycle 1 plus Bendamustine 70 mg/m2 iv d1+2 of each of four 28 -day cycles If at least 'stable disease': Obinutuzumab flat dose of 1000 mg at weeks 21, 29, 37 and 45 The project attempts to establish an evidence based treatment strategy for medically non-fit advanced stage FL-patients who are not eligible for standard therapeutic immunochemotherapy approaches to improve their long term perspectives. It will furthermore provide a prospectively generated data set which will link performance in the assessment scores IADL, G8 and CIRS-G to medical fitness as judged by the treating physician. The generated data will allow using geriatric and functional tests to define medical fitness and to provide a more solid basis for future studies. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03492775
Study type Interventional
Source Ludwig-Maximilians - University of Munich
Contact
Status Completed
Phase Phase 2
Start date December 12, 2017
Completion date December 31, 2022

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