Trials Sponsors Conditions Drugs Pricing

Conditions

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

Keywords

venetoclax; obinutuzumab; atezolizumab; lymphoma

Outcome Measures

Primary Outcomes (2)

FL and DLBCL cohorts : Overall Metabolic Response Rate (OMRR) at the end of induction
Assessment of disease response according to Lugano 2014
8 months (8 cycles)
for iNHL cohort : Overall Response Rate (ORR) at the end of induction
Assessment of disease response according to Lugano 2014
8 months (8 cycles)

Secondary Outcomes (6)

Progression Free Survival (PFS)
4 years

Study Arms (1)

Experimental

EXPERIMENTAL

Combination of venetoclax, atezolizumab and obinutuzumab

Drug: AtezolizumabDrug: ObinutuzumabDrug: Venetoclax

Interventions

AtezolizumabDrug

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

Also known as: Tecentriq

Experimental

ObinutuzumabDrug

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

Also known as: Gazyvaro

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histologically documented CD20-positive follicular lymphoma (WHO grade 1, 2, or 3a) patients for cohort 1
Patients with either histologically documented CD20-positive Diffuse large-cell lymphoma (including transformations of low-grade lymphoma into DLBCL) or follicular lymphoma CD20+ grade 3b, or primary cutaneous DLBCL leg type, or primary mediastinal (thymic) large B-cell lymphoma, or high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, or unclassifiable B-cell lymphoma with features intermediate between DLBCL and Hodgkin (WHO classification) for cohort 2

Sponsors & Collaborators

The Lymphoma Academic Research Organisation
Otherlead

Study Sites (25)

CHU d'Angers

Angers, 49933, France

CHU de Caen

Caen, 14000, France

CHU de Clermont Ferrand - Estaing

Clermont-Ferrand, 63000, France

Hopital Henri Mondor

Créteil, 94010, France

CHU de Dijon

Dijon, 21000, France

CH Annecy Gennevois

Épagny, 74370, France

CHD de Vendée

La Roche-sur-Yon, 85925, France

MeSH Terms

Conditions

Lymphoma, FollicularLymphoma, Large B-Cell, DiffuseLymphoma, B-Cell, Marginal ZoneLymphoma

Interventions

atezolizumabobinutuzumabvenetoclax

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative Disorders

Study Officials

Guillaume CARTRON, PhD
Lymphoma Study Association
PRINCIPAL INVESTIGATOR
Charles HERBAUX, MD
Lymphoma Study Association
PRINCIPAL INVESTIGATOR

Enrollment

136 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 7, 2017

First Posted

September 8, 2017

Study Start

February 12, 2018

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (6)

Study Arms (1)

Experimental

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (25)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (6)

Study Arms (1)

Experimental

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (25)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations