A Randomized Phase II Trial Evaluating Ibrutinib Plus CD20 Ab and Venetoclax in Patients With Untreated Mantle Cell Lymphoma
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.
• 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:
‣ Aspartate transaminase (AST) and alanine transaminase (ALT) \< 3.0 x upper limit of normal (ULN)
⁃ Bilirubin \< 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
⁃ 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