NCT05068440已完成2 期
A Phase 2, Single-Arm, Open-Label, Multicenter Study of the Bruton Tyrosine Kinase Inhibitor Zanubrutinib in Patients With CD79B Mutant Relapsed/Refractory Diffuse Large B-Cell Lymphoma
BeiGene25 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2021年8月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 25
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The goal of this clinical trial was to evaluate whether zanubrutinib can effectively treat adults with CD79B-mutant relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Participants received zanubrutinib as monotherapy, underwent regular disease assessments to evaluate treatment response, and were monitored for safety and side effects throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants had histologically confirmed diffuse large B-cell lymphoma, based on the World Health Organization 2008 classification of tumors of hematopoietic and lymphoid tissue.
- •Participants had a positive CD79B gene mutation, as confirmed by a central laboratory.
- •Participants had previously received at least one line of adequate systemic therapy for diffuse large B-cell lymphoma, defined as anti-CD20 antibody-based chemoimmunotherapy administered for at least two consecutive cycles, unless disease progression occurred before completion of Cycle
- •Participants had relapsed or refractory disease prior to study entry, defined as either:
- •Recurrent disease after achieving disease remission, defined as a complete response or partial response, at the completion of the most recent treatment regimen; or
- •Stable disease or progressive disease at the completion of the most recent treatment regimen.
- •Participants were ineligible for high-dose therapy and stem cell transplantation, defined as meeting at least one of the following criteria:
- •a. Presence of significant organ dysfunction, such as:
- •Left ventricular ejection fraction less than 50 percent as measured by echocardiogram or multiple gated acquisition scan;
- •Diffusing capacity of the lung for carbon monoxide less than 60 percent of the predicted value as measured by pulmonary function testing; or
- •Creatinine clearance less than 70 milliliters per minute as demonstrated by nuclear medicine scan or 24-hour urine collection; or comorbid conditions that precluded the use of high-dose therapy and stem cell transplantation due to an unacceptable risk of treatment-related morbidity.
- •b. Failure to achieve a complete response or partial response following salvage therapy.
- •c. Failure to collect stem cells or inability to undergo stem cell collection, as assessed by the investigator.
排除标准
- •Participants had non-Hodgkin lymphoma other than classical histology diffuse large B-cell lymphoma (not otherwise specified), including but not limited to:
- •Diffuse large B-cell lymphoma transformed from indolent lymphomas
- •Primary mediastinal (thymic) large B-cell lymphoma
- •Primary cutaneous diffuse large B-cell lymphoma
- •Primary effusion lymphoma
- •Central nervous system lymphoma
- •Participants had a history of allogeneic stem cell transplantation or chimeric antigen receptor T-cell therapy.
- •Participants had prior exposure to a Bruton's tyrosine kinase inhibitor.
- •Participants had received any of the following treatments within the specified timeframe prior to the first dose of study drug:
- •Corticosteroids administered with antineoplastic intent within two weeks prior to study treatment. A short course (seven days or fewer) of systemic corticosteroids at doses of 20 milligrams per day or less of prednisone equivalent for control of lymphoma-related symptoms was permitted prior to enrollment, provided the corticosteroids were tapered off within five days after initiation of study treatment.
- •Chemotherapy or radiotherapy within two weeks.
- •Monoclonal antibody therapy within two weeks.
- •Investigational therapy within two weeks.
- •Chinese patent medicine administered with antineoplastic intent within two weeks.
- •Participants had a history of other active malignancies within two years prior to study entry, with the exception of:
- •Adequately treated carcinoma in situ of the cervix;
- •Localized basal cell carcinoma or squamous cell carcinoma of the skin; or
- •A previous malignancy that was confined and treated locally (by surgery or other modality) with curative intent.
- •Note: Other protocol-defined inclusion and exclusion criteria may have applied.
研究组 & 干预措施
Zanubrutinib
Experimental
Participants received zanubrutinib 160 mg orally twice daily, administered continuously until disease progression, unacceptable toxicity, withdrawal of consent, initiation of alternative anticancer therapy, loss to follow-up, or study completion.
干预措施: Zanubrutinib (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: Response was assessed every 12 weeks for the first 24 months and every 24 weeks thereafter. Maximum time on study was 36.4 months
Defined as the percentage of participants who achieved complete response (CR) or partial response (PR) by investigator assessment according to the Lugano classification for Non-Hodgkin's Lymphoma (NHL).
次要结局
- Complete Response Rate (CRR)(Response was assessed every 12 weeks for the first 24 months and every 24 weeks thereafter. Maximum time on study was 36.4 months)
- Duration of Response (DOR)(From the date of first documented response until to the data cutoff date (31MAR2025). Maximum time on study was 36.4 months)
- Progression-free Survival (PFS)(From first dose until the data cutoff date (31MAR2025). Maximum time on study was 36.4 months)
- Time to Response (TTR)(From first dose until disease progression or death, assessed up to the data cutoff date (31MAR2025). Maximum time on study was 36.4 months)
- Overall Survival (OS)(From first dose until the data cutoff date (31MAR2025). Maximum time on study was 36.4 months)
- Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(From the first dose until 30 days after the last dose of zanubrutinib, death, or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months)
研究者
研究点 (25)
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