Phase
Condition
Lymphoma, B-cell
Lymphoma
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: General Inclusion Criteria:
At least one bi-dimensionally measurable lymphoma lesion on CT scan defined as > 1.5cm in its longest dimension, which is also FDG avid by screening PET scan.
Confirmed availability of archival or freshly biopsied tumor tissue prior to studyenrollment
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Adequate hematologic function
For female participants of childbearing potential, agreement to use highly effectiveforms of contraception Dose-Escalation Portion of the Study:
Participants must have histologically confirmed B‑cell NHL, except MCL or SLL
Participants must have never received previous R-CHOP treatment
Any relapsed/refractory participants that are enrolled during the dose escalationshould have received only a single previous treatment regimen Expansion Portion of the Study:
Participants must have previously untreated CD20‑positive DLBCL and IPI score must be 2-5
Exclusion
Exclusion Criteria: General Exclusion Criteria:
History of severe allergic or anaphylactic reactions to humanized or murine monoclonalantibodies or known sensitivity or allergy to murine products
Contraindication to receive any of the individual components of CHOP, rituximab orobinutuzumab
Prior anthracycline therapy
Participants with ongoing corticosteroid use >30 mg per day of prednisone orequivalent
CNS lymphoma or primary mediastinal DLBCL
Vaccination with live vaccines within 28 days prior to randomization
Chemotherapy or other investigational therapy within 28 days prior to the start ofCycle 1
History of other malignancy that could affect compliance with the protocol orinterpretation of results
Evidence of significant, uncontrolled concomitant disease
Significant cardiovascular disease or significant pulmonary disease
Left ventricular ejection fraction less than (<) 50% as defined by multiple-gatedacquisition (MUGA)
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episodeof infection requiring treatment with IV antibiotics or hospitalization (relating tothe completion of the course of antibiotics) within 4 weeks prior to Cycle 1 Day 1
Received the following agents within 7 days prior to the first dose of venetoclax:steroid therapy for anti-neoplastic intent; strong and moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers; grapefruit/grapefruit products, seville oranges or starfruit within 3 days prior to the first dose of venetoclax
Clinically significant history of liver disease, including viral or other hepatitis,current alcohol abuse, or cirrhosis
Recent major surgery
Women who are pregnant or lactating Dose-Escalation Portion of the Study:
Participants with confirmed mantle cell lymphoma (MCL) or small lymphocytic lymphoma (SLL) Expansion Portion of the Study:
Participants with transformed lymphoma (participants with discordant bone marrowinvolvement (i.e., low grade histology in bone marrow) may be considered afterdiscussion with the Medical Monitor)
Prior therapy for NHL
Study Design
Connect with a study center
Concord Repatriation General Hospital
Concord, New South Wales 2139
AustraliaSite Not Available
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
AustraliaSite Not Available
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East Melbourne, Victoria 3002
AustraliaSite Not Available
Peter MacCallum Cancer Centre-East Melbourne
Melbourne, Victoria 3000
AustraliaSite Not Available
Royal Melbourne Hospital
Parkville, Victoria 3050
AustraliaSite Not Available
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, 5020
AustriaSite Not Available
Medizinische Universität Wien
Wien, 1090
AustriaSite Not Available
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
CanadaSite Not Available
BC Cancer Agency, CSI
Kelowna, British Columbia V1Y 5L3
CanadaSite Not Available
BC Cancer Agency Vancouver Centre - PARENT; BC Cancer Agency
Vancouver, British Columbia V5Z 4E6
CanadaSite Not Available
Jewish General Hospital; Research Unit
Montréal, Quebec H3T 1E2
CanadaSite Not Available
CHU de Quebec - Hôpital de l' Enfant Jésus
Quebec, G1J 1Z4
CanadaSite Not Available
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Praha, 128 08
Czech RepublicSite Not Available
Fakultni nemocnice Brno
Brno, 613 00
CzechiaSite Not Available
Fakultni nemocnice Hradec Kralove
Hradec Kralove, 500 05
CzechiaSite Not Available
Fakultni nemocnice Ostrava
Ostrava - Poruba, 708 52
CzechiaSite Not Available
Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK
Praha 2, 128 08
CzechiaSite Not Available
Hopital Henri Mondor, Unite Hemopathies lymphoides
Creteil, 94010
FranceSite Not Available
Centre Hospitalier Départemental Les Oudairies
La Roche sur Yon, 85025
FranceSite Not Available
Clinique Victor Hugo; Pharmacie
Le Mans, 72015
FranceSite Not Available
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Le Mans Cedex 02, 72015
FranceSite Not Available
Hopital Claude Huriez - CHU Lille
Lille, 59037
FranceSite Not Available
Hopital Saint Eloi
Montpellier, 34295
FranceSite Not Available
CHU Nantes - Hôtel Dieu; Service Assistance Medicale à la Procreation
Nantes, 44093
FranceSite Not Available
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Nimes, 30029
FranceSite Not Available
Hôpital Saint-Louis
Paris, 75475
FranceSite Not Available
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Pierre Benite, 69495
FranceSite Not Available
Centre Hospitalier Lyon Sud
Pierre-Benite, 69495
FranceSite Not Available
CHU Rennes - Hopital Pontchaillou
Rennes cedex 09, 35033
FranceSite Not Available
Centre Henri Becquerel; Hematologie
Rouen, 76038
FranceSite Not Available
CHU Tours - Hôpital Bretonneau
Tours, 37044
FranceSite Not Available
Hôpital de Brabois Adultes
Vandoeuvre-les-nancy, 54511
FranceSite Not Available
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Freiburg, 79106
GermanySite Not Available
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Homburg/Saar, 66424
GermanySite Not Available
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Koeln, 50937
GermanySite Not Available
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Ulm, 89081
GermanySite Not Available
Orszagos Onkologiai Intezet
Budapest, 1122
HungarySite Not Available
Semmelweis Egyetem
Budapest, 1083
HungarySite Not Available
Debreceni Egyetem; Belgyogyaszati Klinika Hematologiai Tanszek
Debrecen, 4032
HungarySite Not Available
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Napoli, Campania 80131
ItalySite Not Available
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Bologna, Emilia-Romagna 40138
ItalySite Not Available
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Roma, Lazio 00133
ItalySite Not Available
Azienda Ospedaliero Universitaria San Martino
Genova, Liguria 16132
ItalySite Not Available
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, Piemonte 10126
ItalySite Not Available
Azienda Ospedaliera Vincenzo Cervello
Palermo, Sicilia 90127
ItalySite Not Available
Azienda Ospedaliero Universitaria Pisana; U.O. Farmaceutica
Pisa, Toscana 56100
ItalySite Not Available
Amsterdam UMC Location VUMC
Amsterdam, 1081 HV
NetherlandsSite Not Available
Erasmus Medisch Centrum
Rotterdam, 3015 GD
NetherlandsSite Not Available
UMC Utrecht
Utrecht, 3508 GA
NetherlandsSite Not Available
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L'Hospitalet de Llobregat, Barcelona 08907
SpainSite Not Available
Hospital Universitari Vall d'Hebron
Barcelona, 08035
SpainSite Not Available
Hospital del Mar
Barcelona, 08003
SpainSite Not Available
ICO l´Hospitalet - Hospital Duran i Reynals; Hematology
Barcelona, 08907
SpainSite Not Available
Hospital Universitario La Paz
Madrid, 280146
SpainSite Not Available
Hospital Universitario Ramon y Cajal
Madrid, 28034
SpainSite Not Available
Hospital Universitario de Salamanca
Salamanca, 37007
SpainSite Not Available
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Huntsville, Alabama 35805
United StatesSite Not Available
St. Jude Heritage Healthcare
Fullerton, California 92835
United StatesSite Not Available
Marin Cancer Care Inc
Greenbrae, California 94904
United StatesSite Not Available
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California 90095
United StatesSite Not Available
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Northridge, California 91325
United StatesSite Not Available
Torrance Health Association
Redondo Beach, California 90277
United StatesSite Not Available
Central Coast Medical Oncology
San Luis Obispo, California 93454
United StatesSite Not Available
Central Coast Medical Oncology
Santa Maria, California 93454
United StatesSite Not Available
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado 80012
United StatesSite Not Available
Rocky Mountain Cancer Centers, LLP
Denver, Colorado 80218
United StatesSite Not Available
Memorial Cancer Institute
Hollywood, Florida 33021
United StatesSite Not Available
The West Clinici
Saint Louis, Missouri 63129
United StatesSite Not Available
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St. Louis, Missouri 63129
United StatesSite Not Available
Hackensack University Medical Center; WFAN - Imus Pediatric Center
Hackensack, New Jersey 07601
United StatesSite Not Available
San Juan Oncology Associates
Farmington, New Mexico 87401
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Uni of Rochester Medical Center; Wilmot Cancer Center, Pharmacy Department
Rochester, New York 14642
United StatesSite Not Available
Mid Ohio Oncology Hematology;ZangMeister Center (West)
Columbus, Ohio 43213
United StatesSite Not Available
Oncology Hematology Care, Inc.
Hamilton, Ohio 45103
United StatesSite Not Available
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Middletown, Ohio 45042
United StatesSite Not Available
University of Pennsylvania; School of Medicine
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Tennessee Oncology
Nashville, Tennessee 37203
United StatesSite Not Available
Rocky Mountain Cancer Centers, LLP
Irving, Texas 75063
United StatesSite Not Available

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