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Gazyvaro and Low Dose Radiotherapy in Early Stage Follicular Lymphoma

NCT03341520 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2026-04-17

No results posted yet for this study

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.

Conditions

  • Stage II Grade 1 Follicular Lymphoma
  • Stage II Grade 2 Follicular Lymphoma
  • Stage I Follicular Lymphoma Grade 1
  • Stage II Follicular Lymphoma Grade 2

Interventions

DRUG

Obinutuzumab Injection [Gazyva]

7x 1000mg flat dose

RADIATION

Low dose radiation Therapy (LDRT)

2 x 2 Gy

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Heidelberg University

    lead OTHER

Principal Investigators

  • Klaus Herfarth, MD · Radiation Therapy, University Hospital of Heidelberg ,Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-24
Primary Completion
2021-11-11
Completion
2024-03-14
FDA Drug
Yes

Countries

  • Germany

Study Locations

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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 NCT03341520 on ClinicalTrials.gov