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History of Changes for Study: NCT03276468
Evaluation of Atezolizumab-Venetoclax-Obinutuzumab Combination in Relapse/Refractory Lymphomas
Latest version (submitted December 6, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 7, 2017 None (earliest Version on record)
2 March 6, 2018 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 October 9, 2018 Contacts/Locations and Study Status
4 January 6, 2020 Study Status
5 March 12, 2020 Study Status
6 March 30, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
7 December 6, 2021 Study Status
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Study NCT03276468
Submitted Date:  September 7, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: GATA
Brief Title: Evaluation of Atezolizumab-Venetoclax-Obinutuzumab Combination in Relapse/Refractory Lymphomas
Official Title: A Phase II Trial Evaluating Combination of Atezolizumab, With Venetoclax and Obinutuzumab for Relapsed/Refractory Lymphomas
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2017
Overall Status: Not yet recruiting
Study Start: November 2017
Primary Completion: November 2019 [Anticipated]
Study Completion: November 2021 [Anticipated]
First Submitted: September 7, 2017
First Submitted that
Met QC Criteria:
September 7, 2017
First Posted: September 8, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
September 7, 2017
Last Update Posted: September 8, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: The Lymphoma Academic Research Organisation
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief 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)
Detailed Description:
Open or close this module Conditions
Conditions: Follicular Lymphoma
Diffuse Large B Cell Lymphoma
Marginal Zone Lymphoma
Mucosa Associated Lymphoid Tissue
Keywords: venetoclax; obinutuzumab; atezolizumab; lymphoma
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
This study is a multicentric open-label phase II trial in 3 cohorts of patients
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 138 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Experimental
Combination of venetoclax, atezolizumab and obinutuzumab
Drug: Atezolizumab
1200 mg on day 2 of each 21-day cycle during 18 months (24 cycles)
Other Names:
  • Tecentriq
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
Other Names:
  • Gazyvaro
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
Other Names:
  • Venclyxto
Open or close this module Outcome Measures
Primary Outcome Measures:
1. FL and DLBCL cohorts : Overall Metabolic Response Rate (OMRR) at the end of induction
[ Time Frame: 8 months (8 cycles) ]

Assessment of disease response according to Lugano 2014
2. for iNHL cohort : Overall Response Rate (ORR) at the end of induction
[ Time Frame: 8 months (8 cycles) ]

Assessment of disease response according to Lugano 2014
Secondary Outcome Measures:
1. Progression Free Survival (PFS)
[ Time Frame: 4 years ]

time from inclusion to the first observation of progression
2. Overall Survival (OS)
[ Time Frame: 4 years ]

time from inclusion to death
3. Duration of Response (DR)
[ Time Frame: 4 years ]

from a confirmed Complete Metabolic Response / Complete Radiologic Response (CMR/CRR) or Partial Metabolic Response / Partial Radiologic Response (PMR/PRR) the first observation of progression
4. for FL and DLBCL cohorts : OMRR
[ Time Frame: 4 months, 18 months ]

According to Lugano 2014
5. for iNHL cohort : ORR
[ Time Frame: 4 months, 18 months ]

According to Lugano 2014
6. Best response
[ Time Frame: 18 months ]

Percentage of each response type according to Lugano 2014
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • 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
  • Patients with relapsed/refractory indolent lymphoma (marginal zone (MZL) or measurable mucosa-associated lymphoid tissue (MALT) lymphoma) for cohort 3
  • Relapsed/refractory NHL after ≥1 prior R-containing regimen with no curative option
  • Aged 18 years or more with no upper age limit
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  • Bi-dimensionally measurable disease defined by at least one single node or tumor lesion > 1.5 cm assessed by CT scan, or Positron Emission Tomography (PET) scan without IV contrast at diagnosis with at least one hypermetabolic lesion
  • Signed written informed consent
  • Life expectancy ≥ 3 months
  • Females of childbearing potential (FCBP) must agree to use one reliable form of contraception or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; 3) dose interruptions; and 4) for at least 18 months after discontinuation of all study treatments
  • Male patients and their partner (FCBP) must agree to use two reliable forms of contraception (condom for males and hormonal method for partners) during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; 3) dose interruptions; and 4) for at least 18 months after discontinuation of all study treatments
  • Patient covered by any social security system

Exclusion Criteria:

  • Lymphocytic lymphoma (LL), waldenström macroglobulinemia, unmeasurable MALT lymphoma, Mantle Cell Lymphoma (MCL) and Follicular lymphoma for cohort 3
  • Known CD20 negative status at last biopsy done (Biopsy at relapse/progression is mandatory)
  • Central nervous system or meningeal involvement by lymphoma
  • Prior history of Progressive Multifocal Leukoencephalopathy (PML)
  • Documented infection with HIV
  • Active Hepatitis B (HB) (positive Hepatitis B surface antigen (Ag-HBs) OR positive serology to hepatitis B (positive Ag-HBs or Hepatitis B core antibody (anti-HBc) or Polymerisation Chain Reaction (PCR) for viral DNA of HBV) Active Hepatitis C (HC) infection (patients with positive HCV serology (anti-HCV) are eligible only if PCR is negative from known HCV RNA)
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) before inclusion, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to first administration of study drug
  • Active immune-related disease criteria
  • Left Ventricular Ejection Fraction (LVEF) < 45% as determined by echocardiography or multiple uptake gated acquisition (MUGA) scan
  • Any serious active disease or co-morbid medical condition (such as New York Heart Association Class III or IV cardiac disease, severe arrhythmia, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including uncontrolled obstructive pulmonary disease and history of bronchospasm or other according to investigator's decision)
  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Any of the following laboratory abnormalities:
  • Hemoglobin < 9 g/dL
  • Absolute neutrophil count (ANC) < 1,000 cells/mm3 (1.0 G/L) unless due to lymphoma
  • Platelet count < 75,000/mm3 (75 x 109/L) unless due to lymphoma
  • Serum glutamic-oxaloacetic transaminase (SGOT) / Aspartate Transaminase (AST) or Serum Glutamic-Pyruvate Transferase (SGPT) / Alanine Transaminase (ALT) 3.0 x upper limit of normal (ULN) unless disease involvement
  • Serum total bilirubin > 2.0 mg/dL (34 μmol/L), except if disease related or in case of Gilbert syndrome
  • Calculated creatinine clearance (Cockcroft-Gault formula or MDRD) of < 50 mL /min
  • International normalized ratio (INR) ≤ 1.5 x ULN for patients not receiving therapeutic anticoagulation
  • Partial thromboplastin time (PTT) or activated PTT (aPTT) > 1.5 x ULN
  • Prior history of malignancies other than lymphoma unless the subject has been free of the disease for ≥ 3 years. Exceptions will be allowed for patients with non-melanoma skin tumors (basal cell or squamous cell carcinoma of the skin) or any surgically removed stage 0 (in situ) carcinoma
  • Any serious medical condition, laboratory abnormality (other than mentioned above), or psychiatric illness that would prevent the subject from signing the informed consent form
  • Contraindication to any drug contained in the study treatment regimen
  • Previous treatment with obinutuzumab, atezolizumab or venetoclax
  • Use of any standard or experimental anti-cancer drug therapy within 28 days prior to first administration of study drug
  • Use of warfarin prior to first administration of study drug and throughout all treatment period (because of potential drug-drug interactions that may potentially increase the exposure of warfarin)
  • Patients taking corticosteroids within 4 weeks prior to first administration of study drug, unless administered at a cumulated dose equivalent to ≤ 3.5mg/kg (within these 4 weeks).
  • Use of the following agents prior to first administration of study drug: Strong and moderate CYP3A inhibitors (including grapefruit juice); Strong and moderate CYP3A inducers
  • Pregnant or lactating females
  • Person deprived of his/her liberty by a judicial or administrative decision
  • Adult person under legal protection
  • Person hospitalized without consent
  • Adult person unable to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness
Open or close this module Contacts/Locations
Central Contact Person: Julie ASSEMAT
Telephone: +334 72 66 93 33
Email: julie.assemat@lysarc.org
Central Contact Backup: Elise GAIRE
Telephone: +334 72 66 93 33
Email: elise.gaire@lysarc.org
Study Officials: Guillaume CARTRON, PhD
Principal Investigator
Lymphoma Study Association
Charles HERBAUX, MD
Principal Investigator
Lymphoma Study Association
Locations: France
CHU d'Angers
Angers, France, 49933
Contact:Contact: Aline Clavert, MD
CHU de Caen
Caen, France, 14000
Contact:Contact: Gandhi DAMAJ, MD
CHU de Clermont Ferrand - Estaing
Clermont-Ferrand, France, 63000
Contact:Contact: Olivier Tournilhac, MD
Hopital Henri Mondor
Créteil, France, 94010
Contact:Contact: Corinne Haioun, MD
CHU de Dijon
Dijon, France, 21000
Contact:Contact: Olivier CASASNOVAS, MD
CH Annecy Gennevois
Epagny, France, 74370
Contact:Contact: Nicolas DAGUINDAU, MD
CHD de Vendée
La Roche-sur-Yon, France, 85925
Contact:Contact: Nadine Morineau, MD
CHU de Grenoble
La Tronche, France, 38700
Contact:Contact: Rémy Gressin, MD
CHRU de Lille
Lille, France, 59037
Contact:Contact: Franck Morschhauser, MD
Centre Léon Bérard
Lyon, France, 69373
Contact:Contact: Emmanuelle Nicolas-Virelizier, MD
Institut Paoli Calmettes
Marseille, France, 13273
Contact:Contact: Réda Bouabdallah
Contact:Principal Investigator: Réda Bouabdallah, MD
CHU de Montpellier
Montpellier, France, 34295
Contact:Contact: Guillaume Cartron, PhD
CHU de Nancy - Brabois
Nancy, France, 54511
Contact:Contact: Pierre Feugier, MD
CHU de Nantes
Nantes, France, 44093
Contact:Contact: Steven Le Gouill, MD
CHU de Nice
Nice, France, 62000
Contact:Contact: Jean-Michel Karsenti, MD
Hôpital Saint Louis
Paris, France, 75010
Contact:Contact: Catherine Thieblemont, MD
Hôpital Necker
Paris, France, 75015
Contact:Contact: Richard Delarue, MD
CHU Lyon Sud
Pierre Bénite, France, 69495
Contact:Contact: Gilles Salles, MD
CHU de Poitiers
Poitiers, France, 86021
Contact:Contact: Vincent Delwail, MD
CHU de Rennes - Hôpital de Pontchaillou
Rennes, France, 35003
Contact:Contact: Roch HOUOT, MD
Centre Henri Becquerel
Rouen, France, 76038
Contact:Contact: Hervé Tilly, MD
Institut Curie - Hôpital René Huguenin
Saint-Cloud, France, 92210
Contact:Contact: Carole Soussain, MD
CHRU de Strasbourg
Strasbourg, France, 67100
Contact:Contact: Luc-Matthieu Fornecker, MD
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, France, 31100
Contact:Contact: Loïc YSEBAERT, MD
CHRU de Tours
Tours, France, 37044
Contact:Contact: Emmanuel Gyan, MD
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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