MedTrace Logo

Frontline Treatment of Follicular Lymphoma With AtezolizUmab and Obinutuzumab With and Without RadiOtherapy

NCT04962126 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-03-21

No results posted yet for this study

Summary

This single-arm phase II interventional study aims to assess disease response to, and toxicity of, a combination of obinutuzumab and atezolizumab, with or without radiotherapy, in treatment naive Follicular Lymphoma.

The study will involve an induction phase and a maintenance phase for responding participants, for up to 24 months. Response to treatment will be monitored using medical imaging and clinical assessment.

Conditions

Interventions

DRUG

Obinutuzumab 25 MG/1 ML Intravenous Solution

For intravenous infusion during: Induction phase: Day 1, 8 and 15 of cycle 1 \& Day 1 of cycle 2-6 (q3/52); Maintenance phase: Day 1 of each cycle (q8/52) for up to 12 cycles.

DRUG

Atezolizumab 1200 MG/40mL Intravenous Solution

For intravenous infusion during induction phase only day 1 of each cycle q3/52 for up to 6 cycles.

RADIATION

4 Gy in 2 fractions

Involved site radiotherapy will only be administered to participants to achieve a PR/SD after at restaging after cycle 2, treatment will be between cycle 3 and 4 of induction treatment.

Sponsors & Collaborators

  • Roche Products Pty Limited

    collaborator UNKNOWN

  • Austin Health

    collaborator OTHER_GOV

  • Ballarat Health Services

    collaborator OTHER

  • Olivia Newton-John Cancer Research Institute

    lead OTHER

Principal Investigators

  • Eliza Hawkes, MBBS · Austin Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-17
Primary Completion
2023-04-30
Completion
2025-07-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

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 NCT04962126 on ClinicalTrials.gov