Status and phase
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Treatments
About
The OASIS II trial is a multicentre, open label, randomized phase II trial. We will compare the efficacy of Ibrutinib/anti-CD20 Ab versus Ibrutinib/anti-CD20 Ab/Venetoclax given as fixed duration combinations in newly diagnosed Mantle Cell Lymphoma (MCL) patients (≥ 18 years and < 80 years of age).
Treatment duration of Ibrutinib and Venetoclax will be a maximum of two years. Patients will be treated with CD20 Ab for 3.5 years.
The primary aim is to assess MRD status at 6 months in both arms.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Patient is ≥ 18 years and < 80 years of age at the time of signing the informed consent form (ICF).
Patient understood and voluntarily signed and dated an ICF prior to any study-specific assessments/procedures being conducted.
Patient willing and able to adhere to the study visit schedule and other protocol requirements
Women of childbearing potential must have negative results for pregnancy test prior to study treatment start and agree to abstain from breastfeeding during study participation and at least 18 months after the last drug administration
Men or women of reproductive potential agree to use acceptable method of birth control during treatment and for eighteen months after the last drug administration.
Histologically confirmed (according to the World Health Organization (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 fluorescence in situ hybridization (FISH) and/or BCL1-IgH PCR)
Untreated MCL
Adequate renal function as demonstrated by a creatinine clearance > 50 mL/min; calculated by Cockcroft Gault formula or Modification of Diet in Renal Disease (MDRD)
Adequate hepatic function per local laboratory reference range as follow:
Stage II-IV disease, measurable with at least lymph node > 1.5 cm and requiring treatment in the opinion of the treating clinician
Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
Life expectancy of more than 3 months.
For France: patient affiliated to any social security system
Exclusion criteria
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.
Impaired organ function (other than liver and renal) which will interfere with the treatment
Hemoglobin level < 10g/dL; Neutrophil count <1 G/L; Platelets < 75 G/L (except if related to lymphoma then platelet must be >50),
Major surgery within 28 days before enrollment
Known central nervous system lymphoma
History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon)
Requires treatment with strong CYP3A inhibitors
Vaccinated with live, attenuated vaccines within 6 months of enrollment (except COVID vaccine)
Known history of human immunodeficiency virus (HIV)
Evidence of other clinically significant uncontrolled condition(s) including but not limited to:
Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study
Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator' opinion, could compromise the patient safety, interfere with the absorption or metabolism of treatment (Ibrutinib, CD20 Ab, venetoclax) or put the study outcomes at undue risk
Pregnant, planning to become pregnant, or lactating woman
Known hypersensitivity to study treatment (CD20 Ab, Ibrutinib, Venetoclax) or to any of the excipients
Known allergy to xanthine oxidase inhibitors or rasburicase
Known glucose-6-phosphate dehydrogenase (G6DP) deficiency
Known bleeding disorders
Severe prior reactions to monoclonal antibodies or with prior significant toxicity (other than thrombocytopenia) from Bcl-2 inhibitor
History of prior other malignancy with the exception of:
Anti-cancer therapies including chemotherapy, radiotherapy or other investigational therapy, including targeted small molecule agents
Biological agents (e.g. monoclonal antibodies) for anti-neoplastic intent: excluded 30 days prior to first dose of venetoclax
Person deprived of his/her liberty by a judicial or administrative decision
Adult person under legal protection
Primary purpose
Allocation
Interventional model
Masking
194 participants in 2 patient groups
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Central trial contact
Anne FAUGIER
Data sourced from clinicaltrials.gov
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