Evaluation of Atezolizumab-Venetoclax-Obinutuzumab Combination in Relapse/Refractory Lymphomas

Sponsor
The Lymphoma Academic Research Organisation
Study ID
NCT03276468
Phase
PHASE2
Status
Completed

Conditions

  • Diffuse Large B Cell Lymphoma
  • Follicular Lymphoma
  • Marginal Zone Lymphoma
  • Mucosa Associated Lymphoid Tissue

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    1200 mg on day 2 of each 21-day cycle during 18 months (24 cycles)
  • Obinutuzumab — DRUG
    1000 mg on day 1, day 8 and day 15 of cycle 1 and each day 1 from cycle 2 to cycle 8
  • Venetoclax — DRUG
    800 mg/d from day 8 of cycle 1, every day during 18 months. For MZL patients wiht lymphocytes\>5 g/l : 50 mg/day: week 1 100mg/day: week 2 200mg/day: week 3 400mg/day: week 4 800mg/day: from week 5

Study Details

This study is a multicenter phase II trial which primary objective is to assess the anti-lymphoma activity of atezolizumab associated with a BCL-2 inhibitor (GDC-199, venetoclax) and an anti-CD20 monoclonal antibody (obinutuzumab) in three separate cohorts: * relapsed/refractory follicular lymphoma (FL) patients * relapsed/refractory aggressive (DLBCL) lymphoma patients * relapsed/refractory other indolent (iNHL) lymphoma patients (MZL and MALT)

Key Dates

Start date
Feb 12, 2018
Status verified
Jan 2023
Primary completion
Sep 19, 2019
Completion
Aug 24, 2022

Study Design

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

Arms

  • Experimental: Experimental
    Combination of venetoclax, atezolizumab and obinutuzumab

Primary Outcome Measure

FL and DLBCL cohorts : Overall Metabolic Response Rate (OMRR) at the end of induction [ Time Frame: 8 months (8 cycles) ]

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