CTIS2023-503235-18-00招募中1 期
An Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of BCL2 Inhibitor BGB-11417 in Patients With Relapsed/Refractory Waldenström’s Macroglobulinemia - BGB-11417-203
Beigene Ltd.0 个研究点目标入组 121 人开始时间: 2023年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 121
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Age = 18 years., Clinical and definitive histologic diagnosis of WM., Meeting = 1 criterion for treatment according to consensus panel criteria from the 2nd International Workshop on Waldenström’s Macroglobulinemia (IWWM)., Patients must have R/R disease to the most recent therapy at study entry unless patients had intolerance to the most recent therapy: •Refractory disease is defined as not attaining at least a MR or progressing while on or within 6 months of completing therapy. •Relapsed disease is defined as attaining at least a MR and meeting the criteria for disease progression beyond 6 months after completing therapy., Adequate organ function., For cohort 1 only, patients must meet 6a and 6b: 6a. Progressed on or after BTK inhibitor treatment before next treatment, or treated with BTK inhibitor (continuous treatment for = 12 weeks) without attaining at least a MR. 6b. Experienced disease progression on or after anti CD20 monoclonal antibody based systemic therapy (containing chemotherapy or proteasome inhibitor) before the next treatment, or completed = 2 continuous treatment cycles of therapy without attaining at least a MR., For cohort 2 only, patients must meet 7a and 7b: 7a. Inability to tolerate a BTK inhibitor despite optimal supportive care measures during BTK inhibitor treatment at the discretion of the investigator. 7b. Experienced disease progression on or after anti-CD20 monoclonal antibody-based systemic therapy (containing chemotherapy or proteasome inhibitor) before the next treatment, or completed = 2 continuous treatment cycles of therapy without attaining at least a MR., For cohort 3 only, patients must meet 8a and 8b: 8a. Progressed on or after BTK inhibitor treatment before next treatment, or treated with BTK inhibitor (continuous treatment for = 12 weeks) without attaining at least a MR. 8b. Patients considered by their treating physician to be unsuitable for chemoimmunotherapy regimens.
排除标准
- •Central nervous system (CNS) involvement by WM., Transformation to aggressive lymphoma, such as diffuse large B cell lymphoma., History of other malignancies = 2 years before study entry., Uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy that was completed = 14 days before the first dose of the study drug.
研究者
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