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

NCT03492775 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-03-31

No results posted yet for this study

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.

Conditions

  • Indolent Non-hodgkin Lymphoma

Interventions

DRUG

Obinutuzumab

Obinutuzumab (GA 101) is a first-in-class, potent, intravenously administered type II anti-CD 20 antibody that is developed by Roche AG for the treatment of B-cell malignancies.

DRUG

Bendamustine

Bendamustine belongs formally to the alkylators, but has been shown to have a unique mechanism of action. The dose limiting toxicity of bendamustine is its reversible suppression of bone marrow function with drops in leukocyte and thromobocyte counts.

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Mundipharma Research GmbH & Co KG

    collaborator INDUSTRY

  • Prof. Dr. Wolfgang Hiddemann

    lead OTHER

Principal Investigators

  • Wolfgang Hiddemann, Prof.Dr. · Hospital of the University of Munich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-12
Primary Completion
2021-11-30
Completion
2022-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03492775 on ClinicalTrials.gov