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

Sponsor
Olivia Newton-John Cancer Research Institute
Study ID
NCT04962126
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Obinutuzumab 25 MG/1 ML Intravenous Solution — DRUG
    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.
  • Atezolizumab 1200 MG/40mL Intravenous Solution — DRUG
    For intravenous infusion during induction phase only day 1 of each cycle q3/52 for up to 6 cycles.
  • 4 Gy in 2 fractions — RADIATION
    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.

Study Details

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.

Key Dates

Start date
Aug 17, 2021
Status verified
Mar 2025
Primary completion
Apr 30, 2023
Completion
Jul 31, 2025

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment naive advanced follicular lymphoma
    All consenting participants will be receive an intravenous infusion of Obinutuzumab (1000mg) + Atezolizumab (1200mg) q3/52 x 6 cycles (plus 1000mg Obinutuzumab on day 8 and 15 of cycle 1). Responding participants (PR or SD) who do not achieve a CR at the end of cycle 2 will receive involved site radiotherapy (4Gy, 2 fractions) between cycle 3 and 4. At the end of cycle 6 and completion of the induction phase, responding participants (CR/PR/SD) will receive maintenance phase Obinutuzumab (1000mg IV) q8/52 for up to 12 cycles.

Primary Outcome Measure

Complete metabolic response rate according to Lugano response criteria [ Time Frame: At the end of cycle 6 (each cycle in the induction phase is 21 days) ]

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