A Phase 3 Randomized, Open-Label, Multicenter Study of Zanubrutinib (BGB 3111) Plus Anti-CD20 Antibodies Versus Lenalidomide Plus Rituximab in Patients With Relapsed/Refractory Follicular or Marginal Zone Lymphoma - BGB-3111-308

Beigene Ltd.0 个研究点目标入组 863 人开始时间: 2023年4月19日最近更新: 2024年8月21日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方
入组人数: 863

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 65+（—）
性别: All

入选标准

•Age of = 18 years at the time of informed consent., Able to provide written informed consent and understand and comply with study requirements., Women of childbearing potential (WOCBP) must: a.Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use highly effective methods of contraception initiated prior to first dose of study drug, for the duration of the study, and for = 90 days after the last dose of zanubrutinib, and according to the approved obinutuzumab and rituximab product/prescribing information, whichever is longer. b.Have 2 negative pregnancy tests (minimum sensitivity 25 mIU/mL) as verified by the Investigator prior to starting study treatment (between Days -14 and -10 before the first dose of study treatment, and the other test is performed = 24 hours before the start of lenalidomide). She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the patient practices true abstinence2 from heterosexual contact. c.Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with two forms of contraception: one highly effective, and one additional effective (barrier) measure of contraception without interruption during screening for all WOCBP, and during the study treatment for WOCBP in Arm B and Arm D (including dose interruptions), and for at least 28 days after the last dose of lenalidomide., Male patients are eligible if: a.Abstinent, vasectomized, or if they agree to use barrier contraception (condom) with other methods (even if vasectomized male patients receiving lenalidomide must practice true abstinence2) during the study treatment period and for = 90 days after the last dose of zanubrutinib, for = 28 days after the last dose of lenalidomide, and according to the approved obinutuzumab and rituximab product/prescribing information, whichever is longer. b.Agree to not donate semen during study treatment therapy and for = 90 days after the last dose of zanubrutinib, for = 28 days after the last dose of lenalidomide, and according to the approved obinutuzumab and rituximab product/prescribing information, whichever is longer., All patients must: a.Have an understanding that the study treatment could have a potential teratogenic risk. b.Agree to abstain from donating blood while taking study treatment therapy and for 4 weeks after discontinuation of study treatment therapy. c.Agree not to share study medication with another person. d.Agree to be counseled about pregnancy precautions and risk of fetal exposure. e.Female patients must agree to abstain from breastfeeding during study participation and for = 14 days after the last dose of zanubrutinib, for = 28 days after the last dose of lenalidomide, and according to the approved obinutuzumab and rituximab product/prescribing information, whichever is longer., Histologically confirmed grade 1-3a FL or MZL according to World Health Organization 2016 classification. All three subtypes of MZL (extranodal, nodal, and splenic) are eligible. NOTE: a formalin-fixed, paraffin-embedded specimen must be available for central review. If an archival specimen is not available, or if suspicion of transformation, a re-biopsy is required before randomization., Previously treated with at least one line of systemic therapy inc

排除标准

•History of transformation to aggressive lymphoma, such as diffuse large B-cell lymphoma or grade 3b FL. If transformation is suspected, a biopsy of the suspected area is required to exclude transformation., Confirmed central nervous system involvement by FL or MZL., Underlying medical conditions that, in the investigator’s opinion, will render the administration of study treatment hazardous or obscure the interpretation of safety., Severely immunocompromised state., History or active infection with human immunodeficiency virus (seropositive patients with sustained undetectable viral load may be enrolled)., Serologic status reflecting active viral HBV or HCV infection as follows: a.Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients with presence of HBcAb, but without HBsAg, are eligible if HBV DNA is undetectable (NOTE: the limit of detection for HBV DNA must have a sensitivity of < 20 IU/mL), and if they are willing to undergo monthly monitoring for HBV reactivation. b.Presence of HCV antibody. Patients with presence of HCV antibody are eligible if HCV RNA is undetectable (NOTE: the limit of detection for HCV RNA must have a sensitivity of < 15 IU/mL) and if they are willing to undergo monthly monitoring for HCV reactivation., Major surgery = 4 weeks before the first dose of study treatment or planned during study., Prior treatment with a BTK inhibitor (including zanubrutinib), Prior treatment with lenalidomide and without response (response is defined as best overall response that is PR or CR) or with short remission (short remission defined as: a response was achieved but the DOR was < 24 months)., Last dose of prior therapy for FL or MZL, including herbal medicine with anti neoplastic intent = 21 days before the first dose of study treatment with additional exclusion requirements: a.Treatment with monoclonal antibody-based therapy (including bispecifics antibody) = 28 days before the first dose of study treatment. b.Chimeric antigen receptor T-cell therapy = 180 days before the first dose of study treatment. c.Allogeneic hematopoietic cell transplantation = 1 year before the first dose of study treatment. d.Autologous hematopoietic stem cell transplantation = 3 months before the first dose of study treatment, Any chemotherapy or radiation treatment for non-FL or MZL indications = 21 days before the first dose of study treatment., Requiring ongoing need for corticosteroid treatment, except for adrenal replacement. NOTE: Systemic corticosteroids must be fully tapered off/stopped = 5 days before the first dose of study treatment., Ongoing toxicity of Grade = 2 from prior anticancer therapy (except for alopecia, ANC, and platelets. For ANC and platelets, please follow inclusion criterion #8)., Pregnant or lactating women., Vaccination with a live vaccine = 35 days before the first dose of study treatment., Hypersensitivity to zanubrutinib, lenalidomide, obinutuzumab or rituximab, murine products, thalidomide, or any of the other ingredients/excipients of the study drugs., Requiring ongoing therapy with strong or moderate cytochrome P450 3A (CYP3A) inducers., Use of strong/moderate CYP3A inhibitors (see Appendix 4) within 7 days or 5 half-lives prior to the first dose of zanubrutinib; usage of strong/moderate CYP3A inducers (see Appendix 4) within 14 days prior to the first dose of zanubrutinib., Patients who are at a risk for a thromboembolic event and are not willing to take venous throm

研究者

发起方

Beigene Ltd.

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