2023-503235-18-00招募中2 期
An Open Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of the BCL2 Inhibitor Sonrotoclax (BGB 11417) as Monotherapy and in Combination with Zanubrutinib (BGB-3111) in Patients With Waldenström Macroglobulinemia
BeOne Medicines AG21 个研究点 分布在 4 个国家目标入组 64 人开始时间: 2024年3月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 21
- 主要终点
- Major response rate (MRR, defined as the proportion of patients achieving partial response [PR] or better per the 11th International Workshop on Waldenström Macroglobulinemia (IWWM) (hereafter as IWWM-11 WM response criteria) as assessed by the Independent Review Committee (Cohort 1)
研究概览
简要总结
To evaluate the efficacy of sonrotoclax in patients with WM who have R/R disease to both Bruton tyrosine kinase (BTK) inhibitor and anti CD20 antibody-based systemic therapy containing chemotherapy or proteasome inhibitor (Cohort 1)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
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) at study entry.
- •For Cohorts 1 to 3, patients must have R/R disease 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 the following: - Experienced disease progression 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. - 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 the following: - Inability to tolerate a BTK inhibitor despite optimal supportive care measures during BTK inhibitor treatment at the discretion of the investigator. - 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 the following: – Experienced disease progression 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. – Patients considered by their treating physician to be unsuitable for chemoimmunotherapy regimens.
- •For Cohort 4 only, patients must not have received prior therapy for WM (except for plasmapheresis).
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.
- •Having uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy that was completed ≤ 14 days before the first dose of the study drug.
- •Received BCL2 inhibitor previously
研究组 & 干预措施
BGB-11417, BGB-11417
Test
干预措施: BGB-11417 (Drug)
Zanubrutinib
Test
干预措施: Zanubrutinib (Drug)
结局指标
主要结局
Major response rate (MRR, defined as the proportion of patients achieving partial response [PR] or better per the 11th International Workshop on Waldenström Macroglobulinemia (IWWM) (hereafter as IWWM-11 WM response criteria) as assessed by the Independent Review Committee (Cohort 1)
Major response rate (MRR, defined as the proportion of patients achieving partial response [PR] or better per the 11th International Workshop on Waldenström Macroglobulinemia (IWWM) (hereafter as IWWM-11 WM response criteria) as assessed by the Independent Review Committee (Cohort 1)
次要结局
- MRR as assessed by the IRC in Cohorts 2 and 3 and by the investigator in Cohorts 1 to 4
- Duration of major response (DoMR) as assessed by the IRC in Cohort 1 to 3 and by the investigator in Cohorts 1 to 4
- Complete response (CR) + very good partial response (VGPR) rate as assessed by the IRC in Cohorts 1 to 3 and by the investigator in Cohorts 1 to 4
- Overall response rate (ORR, defined as the proportion of patients achieving minor response [MR] or better) as assessed by the IRC in Cohorts 1 to 3 and by the investigator in Cohorts 1 to 4
- Progression free survival (PFS) as assessed by the IRC and investigator in Cohorts 1 to 3
- Time to major response as assessed by the IRC in Cohorts 1 to 3 and by the investigator in Cohorts 1 to 4
- Overall survival (OS) in Cohorts 1 to 3
- The frequency and severity of adverse events, serious adverse events, and laboratory abnormalities according to National Cancer Institute Common Terminology for Adverse Event (NCI CTCAE v5.0)
- Health-related quality of life (HRQoL) based on patient reported outcomes (PRO) using National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index 18 Item (NFLymSI-18) Version 4
- Duration of response (DOR) as assessed by the IRC in Cohorts 1 to 3 and by the investigator in Cohorts 1 to 4
- Time to next treatment in Cohort 4
研究者
BeOne Medical Officer
Scientific
BeOne Medicines AG
研究点 (21)
Loading locations...
相似试验
招募中
2 期
Sonrotoclax Plus Dexamethasone With or Without Daratumumab Regimen in Patients With t(11;14) Primary AL AmyloidosisNCT07335887Peking University People's Hospital39
招募中
3 期
A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic LeukemiaChronic Lymphocytic LeukemiaNCT07277231BeOne Medicines500
招募中
2 期
Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell TherapyMantle Cell LymphomaNCT07341191Canadian Cancer Trials Group40
招募中
3 期
Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated CLL/SLLChronic Lymphocytic LeukemiaNCT07321652Alliance for Clinical Trials in Oncology466
招募中
2 期
A Phase 2 Study to Investigate Sonrotoclax combined with Zanubrutinib Versus Zanubrutinib alone in Patients With Previously Untreated Chronic Lymphocytic Leukemia2024-513970-23-00Beigene Ltd.39