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

NCT03276468 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2023-01-10

No results posted yet for this study

Summary

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)

Conditions

Interventions

DRUG

Atezolizumab

1200 mg on day 2 of each 21-day cycle during 18 months (24 cycles)

DRUG

Obinutuzumab

1000 mg on day 1, day 8 and day 15 of cycle 1 and each day 1 from cycle 2 to cycle 8

DRUG

Venetoclax

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

Sponsors & Collaborators

  • The Lymphoma Academic Research Organisation

    lead OTHER

Principal Investigators

  • Guillaume CARTRON, PhD · Lymphoma Study Association

  • Charles HERBAUX, MD · Lymphoma Study Association

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-12
Primary Completion
2019-09-19
Completion
2022-08-24

Countries

  • France

Study Locations

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Entities

Drugs
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 NCT03276468 on ClinicalTrials.gov