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 - VEGA

Janssen-Cilag International NV0 个研究点目标入组 490 人开始时间: 2022年9月15日最近更新: 2024年2月26日

适应症

试验速览

暂无简介。

•-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
•-Adequate organ function
•ANC = 1000/mm^3
•Platelets =50,000 cells/mm^3
•Hemoglobin =8 g/dL
•ALT/AST =3 X ULN
•Total bilirubin =1.5 X ULN
•CrCl =30 mL/min
•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 400
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 90

•-Prior therapy with BTKi
•-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)
•-HIV, active Hep B/C and E infection

发起方