First Line Therapy of Advanced Stage Follicular Lymphoma in Patients < 60 Years Not Eligible fo Standard Immunochemotherapy and in All Patients ≥ 60 Years — GABe2016  

Indolent Non-hodgkin Lymphoma Clinical Trial

Official title: Prospective Randomized Evaluation of Single Agent GA101 Versus GA101 Plus Bendamustine Followed by GA101

Status Completed

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. ;

Related Conditions & MeSH terms

• Indolent Non-hodgkin Lymphoma
• Lymphoma

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