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COMPLETED
NCT03341520
PHASE2

Gazyvaro and Low Dose Radiotherapy in Early Stage Follicular Lymphoma

Sponsor: Heidelberg University

View on ClinicalTrials.gov

Summary

Combined modality approach using Obitunuzumab and involved site low dose irradiation in early stage nodal follicular lymphoma. Radiation dose will be adapted for low-responders. Primary Objective: Evaluation of the rate of metabolic CR after low-dose involved site radiotherapy in combination with Gazyvaro (Obinutuzumab) in early stage nodal follicular lymphoma in order to avoid conventional full dose IF radiotherapy. Secondary Objective: Efficacy and safety of a response adapted radiation dose treatment schedule.

Official title: Therapy of Nodal Follicular Lymphoma (WHO Grade 1/2) in Clinical Stage I/II Using Response Adapted Involved Site Radiotherapy in Combination With Gazyvaro

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

89

Start Date

2018-04-24

Completion Date

2024-03-14

Last Updated

2026-04-17

Healthy Volunteers

No

Interventions

DRUG

Obinutuzumab Injection [Gazyva]

7x 1000mg flat dose

RADIATION

Low dose radiation Therapy (LDRT)

2 x 2 Gy

Locations (12)

University of Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Vivantes Klinikum

Berlin, Germany

University of Cologne

Cologne, Germany

University of Essen

Essen, Germany

University of Frankfurt

Frankfurt, Germany

University of Heidelberg

Heidelberg, Germany

Klinikum Kempten

Kempten, Germany

Site Marburg

Marburg, Germany

LMU

Munich, Germany

TU

Munich, Germany

University of Muenster

Münster, Germany

University of Ulm

Ulm, Germany