drugset / Trial / NCT03492775
First Line Therapy of Advanced Stage Follicular Lymphoma in Patients < 60 Years Not Eligible fo Standard Immunochemotherapy and in All Patients ≥ 60 Years
Phase 2
Completed
46 enrolled
Prof. Dr. Wolfgang Hiddemann
Hoffmann-La Roche · collabMundipharma Research GmbH & Co KG · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2017-12-12
- Primary completion
- 2021-11-30
- Completion
- 2022-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bendamustine | Small molecule | 70 mg/m2 | Intravenous |
| Comparator | Obinutuzumab | Monoclonal antibody | 1000 mg | Intravenous |