Non Hodgkin Lymphoma Clinical Trial
Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (SYMPATICO)
This Phase 3 multinational, randomized, double-blind study is designed to compare the efficacy and safety of the combination of ibrutinib and venetoclax vs. ibrutinib and placebo in subjects with MCL.
Pathologically confirmed MCL (in tumor tissue), with documentation of either overexpression of cyclin D1 in association with other relevant markers (eg, CD19, CD20, PAX5, CD5) or evidence of t(11;14) as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR).
At least 1 measurable site of disease on cross-sectional imaging (CT/PET).
At least 1, but no more than 5, prior treatment regimens for MCL.
Failure to achieve at least partial response (PR) with, or documented disease progression after, the most recent treatment regimen.
Subjects must have adequate fresh or paraffin embedded tissue.
Adequate hematologic, hepatic and renal function.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of <= 2.
History or current evidence of central nervous system lymphoma.
Concurrent enrollment in another therapeutic investigational study or prior therapy with ibrutinib or other BTK inhibitors.
Prior treatment with venetoclax or other BCL2 inhibitors.
Anticancer therapy including chemotherapy, radiotherapy, small molecule and investigational agents 21 days prior to receiving the first dose of study drug.
Treatment with any of the following within 7 days prior to the first dose of study drug: moderate or strong cytochrome P450 3A (CYP3A) inhibitors or strong CYP3A inducers.
Treatment Naïve Arm
Pathologically confirmed treatment-naive MCL (tumor tissue), with documentation of either overexpression of cyclin D1 in association with other relevant markers (eg, CD19, CD20, PAX5, CD5) or evidence of t(11;14), as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR).
Men and women ≥18 years of age with a TP53 mutation.
At least 1 measurable site of disease.
Must have adequate fresh or paraffin-embedded tissue.
Eastern Cooperative Oncology Group (ECOG) performance status score 0-2.
Adequate hematologic, hepatic, and renal function.
Blastoid variant of MCL
History or current evidence of CNS lymphoma.
Concurrent enrollment in another therapeutic investigational study or prior therapy including ibrutinib or other BTK inhibitors.
Prior treatment with venetoclax or other BCL2 inhibitors.
Vaccinated with live, attenuated vaccines within 4 weeks of the first dose of study drug.
Clinically significant infection requiring IV systemic treatment that was completed <=14 days before the first dose of study drug.
Any uncontrolled active systemic infection.
Known bleeding disorders (eg, von Willebrand's disease or hemophilia).
History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
History of HIV or active HCV or HBV.
Major surgery within 4 weeks of the first dose of study drug.
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the participant's safety or put the study outcomes at undue risk.
Currently active, clinically significant cardiovascular disease; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization.
Unable to swallow capsules or tablets, or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction.
Treatment with any of the following within 7 days prior to the first dose of study drug: Moderate or strong cytochrome P450 3A (CYP3A) inhibitors or moderate or strong CYP3A inducers.
Known allergy to xanthine oxidase inhibitors and/or rasburicase for subjects with known risk factors (as defined by high tumor burden and/or diminished renal function, as detailed in "Study Design" section above) for TLS.
Chronic liver disease with hepatic impairment Child-Pugh class B or C.
Unwilling or unable to participate in all required study evaluations and procedures.
Known hypersensitivity to the active ingredient or other components of one or more study drugs.
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There are 119 Locations for this study
Tucson Arizona, 85719, United States
Duarte California, 91010, United States
Los Angeles California, 90095, United States
Orlando Florida, 32806, United States
Westwood Kansas, 66205, United States
Louisville Kentucky, 40207, United States
Detroit Michigan, 48201, United States
New York New York, 10065, United States
New York New York, 11794, United States
Charlotte North Carolina, 28204, United States
Chattanooga Tennessee, 37404, United States
Knoxville Tennessee, 37920, United States
Houston Texas, 77030, United States
Seattle Washington, 98194, United States
Canberra Australian Capital Territory, 2605, Australia
Albury New South Wales, 2640, Australia
Auchenflower Queensland, 4101, Australia
Heidelberg Victoria, 3084, Australia
Melbourne Victoria, 3000, Australia
Melbourne Victoria, 3065, Australia
Nedlands Western Australia, 6009, Australia
Antwerpen , 2060, Belgium
Brugge , 8000, Belgium
Bruxelles , 1000, Belgium
Yvoir , 5530, Belgium
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Vancouver British Columbia, V5Z 4, Canada
Halifax Nova Scotia, B3H 2, Canada
Ottawa Ontario, K1H 8, Canada
Montréal Quebec, H3T 1, Canada
Brno , 625 0, Czechia
Hradec Králové , 500 0, Czechia
Olomouc , 77900, Czechia
Ostrava-Poruba , 708 5, Czechia
Praha 10 , 100 3, Czechia
Praha 2 , 128 0, Czechia
CAEN Cedex Calvados, 14033, France
Bordeaux , 33076, France
Clermont Ferrand cedex , 63003, France
Marseille , 13009, France
Nice Cedex 2 , 06189, France
Paris , 75010, France
Pierre Benite cedex , 69495, France
Tours Cedex 01 , 37044, France
Mutlangen Baden-Wuttemberg, 73557, Germany
Ulm Baden-Wuttemberg, 89081, Germany
Muenchen Bayern, 81377, Germany
Kerpen Koln, 50937, Germany
Langen Mainz, 55131, Germany
Dresden Sachsen, 01307, Germany
Berlin , 10967, Germany
Berlin , 12200, Germany
Essen , 45147, Germany
Homburg/Saar , 66421, Germany
Alexandroupolis , 68100, Greece
Athens , 11525, Greece
Athens , 11527, Greece
Athens , 11528, Greece
Ioánnina , 45500, Greece
Larissa , 41110, Greece
Patra , 26504, Greece
Budapest , 1122, Hungary
Budapest , 1125, Hungary
Debrecen , 4032, Hungary
Győr , 9024, Hungary
Kaposvár , 7400, Hungary
Szeged , 6725, Hungary
Szombathely , 9700, Hungary
Alessandria Alessandria/Piemonte, 15121, Italy
Bergamo Bergamo/Lombardia, 21427, Italy
Bologna Bologna/Emilia-Romagna, 40138, Italy
Brescia Brescia/Lombardia, 25123, Italy
Cuneo Cuneo/Piemonte, 12100, Italy
Meldola Forli-Cesena/Emilia-Rom, 47014, Italy
Milano Milano/Lombardia, 20132, Italy
Milano Milano/Lombardia, 20162, Italy
Pavia Pavia/Lombardia, 27100, Italy
Torino Torino/Piemonte, 10126, Italy
Udine Udine/Friuli-Venezia Giulia, 33010, Italy
Incheon , 21565, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Groningen , 9713 , Netherlands
Hoofddorp , 2134 , Netherlands
Leiden , 2333 , Netherlands
Rotterdam , 3015 , Netherlands
Schiedam , 3118 , Netherlands
Bydgoszcz , 85-16, Poland
Chorzów , 41-50, Poland
Kraków , 30-51, Poland
Warszawa , 02-77, Poland
Wrocław , 50-36, Poland
Łódź , 93-51, Poland
Gijón Asturias, 33203, Spain
Badalona Barcelona, 08916, Spain
L'Hospitalet De Llobregat Barcelona, 08907, Spain
Pamplona Navarra, 31008, Spain
Barcelona , 08041, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Kurupelit Samsun, 55139, Turkey
Ankara , 06500, Turkey
İzmir , , Turkey
Tekirdağ , 59030, Turkey
Cherkasy , 18009, Ukraine
Kharkiv , 61070, Ukraine
Kyiv , 03022, Ukraine
Kyiv , 03115, Ukraine
Uzhgorod , 88018, Ukraine
Zhytomyr , 10002, Ukraine
London Greater London, EC1A , United Kingdom
Manchester Greater Manchester, M20 4, United Kingdom
Nottingham Nottinghamshire, NG5 1, United Kingdom
Oxford Oxfordshire, OX3 7, United Kingdom
Sutton Surrey, SM2 5, United Kingdom
Leeds West Yorkshire, LS9 7, United Kingdom
London , NW1 2, United Kingdom
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