A randomized phase II trial evaluating Ibrutinib plus CD20 Ab and Ibrutinib-Venetoclax plus CD20 Ab in patients with untreated mantle cell lymphoma - OASIS-II

YSARC0 sites194 target enrollmentFebruary 24, 2021

Overview

No summary available.

Registry

who.int

Start Date

February 24, 2021

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

YSARC

•Histologically confirmed (according to the WHO classification) mantle cell lymphoma. The diagnosis has to be confirmed by phenotypic expression of CD5, CD20 and cyclin D1 or the t(11;14\) translocation (by cytogenetics and/or FISH and/or BCL1\-IgH PCR)
•Untreated MCL
•Stage II\-IV disease, measurable with at least lymph node \> 1\.5 cm and requiring treatment in the opinion of the treating clinician
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 154
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 40

•1\.Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification.
•2\.Impaired organ function (other than liver and renal) which will interfere with the treatment
•3\.Hemoglobin level \< 10g/dL; Neutrophil count \<1 G/L; Platelets \< 75 G/L (except if related to lymphoma then platelet must be \>50\),
•4\.Major surgery within 28 days before enrollment
•5\.Known central nervous system lymphoma
•6\.History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
•7\.Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumone)
•8\.Requires treatment with strong CYP3A inhibitors
•9\.Vaccinated with live, attenuated vaccines within 6 months of enrollment (except COVID vaccine)
•10\.Known history of human immunodeficiency virus (HIV)