A Randomized, Controlled, Open-label, Multicenter, Inferentially Seamless Phase 2/3 Study of Ibrutinib in Combination With Rituximab Versus Physician’s Choice of Lenalidomide Plus Rituximab or Bortezomib Plus Rituximab in Participants with Relapsed or Refractory Mantle Cell Lymphoma - 54179060MCL3004

Janssen - Cilag International0 个研究点目标入组 30 人开始时间: 2023年9月26日最近更新: 2024年7月22日

试验速览

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•Adult patients with confirmed MCL, At least 1 prior treatment regimen for MCL excl. BTKi, Documented disease progression or relapse following the last anti-MCL treatment, Measurable nodal disease, ECOG =1, Adequate organ function: ANC = 1000/mm3 Platelets =50,000 cells/mm3 Hemoglobin =8 g/dL ALT/AST =3 X ULN Total bilirubin =1.5 X ULN CrCl =30 mL/min, Must not be diagnosed or treated for malignancy other than MCL (with exceptions), FOCBP and male participants with partners of childbearing potential must also comply with strict pregnancy prevention plan

•Prior therapy with BTKi, Known history of HIV, Active Hep B/C and E infection, Prior therapy with both Lenalidomide and Bortezomib, Major surgery within 4 weeks, History of stroke or intracranial hemorrhage within 6 month prior to randomization, Central nervous system lymphoma, Bleeding disorder, Clinically significant cardiovascular disease (e.g., uncontrolled arrhythmia, or Class II-IV congestive heart failure as defined by NYHA); or a history of MI, unstable angina, or acute coronary syndrome within 1 year prior to randomization (if >1 yr., a cardiology consultation documenting cardiac clearance is required) or uncontrolled HTN under treatment with 3 or more HTN medications, screening systolic BP>160 mm HG or diastolic BP>100mm Hg, Anticancer therapy including chemotherapy, radiotherapy, small molecule, monoclonal antibody and investigational agents =21 days (or at least 5 drug half-lives, whichever is shorter) prior to first administration of study treatment, Uncontrolled active systemic infection or any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the participant's safety, or interfere with the absorption or metabolism of ibrutinib (including uncontrolled diabetes mellitus or HbA1C>7)

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