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一项评估 Venetoclax 对接受共价布鲁顿酪氨酸激酶抑制剂 (cBTKi) 治疗一线慢性淋巴细胞白血病 (1L CLL) 的参与者实现深度持久缓解以允许停药期的影响的研究 (BRAVE)

2026年9月25日 更新者：Genentech, Inc.

II 期、开放标签、前瞻性单臂、多中心临床试验，评估在共价 BTKi 治疗 1L CLL 的患者中添加 Venetoclax 是否可以实现深度持久缓解（根据 UMRD 10^-4）以允许停药期

The main purpose of the study is to evaluate if adding venetoclax to participants receiving cBTKi for the 1L CLL can achieve deep durable remissions of undetectable measurable residual disease [uMRD < or 10^-4 in peripheral blood (PB)] by end of combination treatment (EOCT) to allow off-treatment period.

The acronym BRAVE stands for Btki Responders to Achieve deep remission (or off-treatment periods) with VEnetoclax.

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (实际的)

118

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Arkansas
      • Springdale、Arkansas、美国、72762
        • Highlands Oncology Group
    • Colorado
      • Aurora、Colorado、美国、80012-5405
        • Rocky Mountain Cancer Centers (Aurora) - USOR
    • Florida
      • Jacksonville、Florida、美国、32256-6932
        • Cancer Specialists of North Florida
    • Indiana
      • Fort Wayne、Indiana、美国、46804
        • Fort Wayne Medical Oncology and Hematology, Inc
    • Iowa
      • Des Moines、Iowa、美国、50314-3030
        • Mission Blood and Cancer - MercyOne Cancer Center
    • Maryland
      • Bethesda、Maryland、美国、20817-1915
        • American Oncology Partners of Maryland, PA
    • Massachusetts
      • Boston、Massachusetts、美国、02215-5418
        • Dana-Farber Cancer Institute - Hematologic Oncology Treatment Center
    • Nebraska
      • Grand Island、Nebraska、美国、68803
        • Nebraska Cancer Specialists St Francis - Grand Island
      • Omaha、Nebraska、美国、68130-2042
        • Nebraska Cancer Specialists
    • New Jersey
      • East Brunswick、New Jersey、美国、08816-4096
        • Astera Cancer Care East Brunswick
    • New Mexico
      • Farmington、New Mexico、美国、87401
        • San Juan Oncology Associates, PC
    • Ohio
      • Cincinnati、Ohio、美国、45236-2725
        • Oncology Hematology Care Inc - Cincinnati - USOR
      • Columbus、Ohio、美国、43210
        • Ohio State University
    • Oregon
      • Eugene、Oregon、美国、97401-6043
        • Willamette Valley Cancer Institute and Research Center
      • Medford、Oregon、美国、97504-8332
        • Asante Rogue Regional Medical Center
    • Tennessee
      • Chattanooga、Tennessee、美国、37404
        • Tennessee Oncology, PLLC - Chattanooga
      • Nashville、Tennessee、美国、37203
        • Tennessee Oncology - Midtown
    • Texas
      • Houston、Texas、美国、77030
        • MD Anderson Cancer Center
      • Tyler、Texas、美国、75702
        • Texas Oncology- Northeast Texas
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • Medical College of Wisconsin

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Diagnosed with CLL and currently receiving a stable dose of cBTKi (i.e., ibrutinib, acalabrutinib, or zanubrutinib) for at least 6 months for 1L treatment with a response of at least a PR per iwCLL criteria
  2. Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to (</=) 2
  3. Adequate renal and liver function

Exclusion Criteria:

  1. Prior B-cell lymphoma (Bcl-2) inhibitor therapy
  2. Anti-cluster of differentiation 20 (CD20) therapy within the month prior to screening
  3. Progressive or stable disease on cBTKi
  4. Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (Richter's transformation or pro-lymphocytic leukemia)
  5. History of cardiomyopathy
  6. Hypersensitivity to venetoclax or to any of the excipients (e.g., trehalose)
  7. Clinically significant cardiovascular disease
  8. Active bleeding or history of bleeding diathesis
  9. Pregnant women and nursing mothers
  10. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Venetoclax Added to cBTKi (Commercially Prescribed)

Participants will receive venetoclax, orally, once daily (QD) with a starting ramp-up dose of 20 milligrams (mg) on Day 1 of Cycle 1 (cycle length= 28 days). The dose will increase weekly; thereafter, treatment will continue with venetoclax at the target dose of 400 mg, QD from Week 5 up to Day 28 of Cycle 12. Participant will discontinue from venetoclax and/or cBTKi after 12 cycles. Participants with detectable measurable residual disease with the presence of less than 1 CLL cell in 10,000 leukocytes (< 10^-4) (MRD4) or uMRD4 with partial response (PR) may continue receiving cBTKi-monotherapy (i.e. ibrutinib or acalabrutinib, or zanubrutinib) as previously prescribed by the investigator according to the prescribing label.
药品：Venetoclax

Venetoclax tablets will be administered as per the schedule specified in the arm.

其他名称：
  • RO5537382
药品：cBTKi Monotherapy

Commercially available cBTKi (ibrutinib or acalabrutinib, or zanubrutinib) will be administered in accordance with its prescribing label.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
uMRD4 Rate at EOCT
大体时间：Cycle 12 Day 28 (Cycle length= 28 Days)

uMRD4 will be assessed using next generation sequencing (NGS) (sensitivity 10^-4) from PB.
Cycle 12 Day 28 (Cycle length= 28 Days)

次要结果测量

结果测量
措施说明
大体时间
CR/CRi Rate at EOCT as Determined by the Investigator According to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines
大体时间：Up to approximately 12 months

Complete response (CR)/complete response with incomplete recovery of the bone marrow (CRi) rate is defined as the percentage of participants with a CR or CRi at EOCT, as determined by the investigator according to the iwCLL.
Up to approximately 12 months
PR Rate at EOCT as Determined by the Investigator According to iwCLL Guidelines
大体时间：Up to approximately 12 months

PR rate is defined as the percentage of participants with a PR at EOCT, as determined by the investigator according to the iwCLL.
Up to approximately 12 months
Overall Response Rate (ORR) at EOCT as Determined by the Investigator According to iwCLL Guidelines
大体时间：Up to approximately 12 months

ORR is defined as the percentage of participants with a CR/CRi or PR at EOCT, as determined by the investigator according to the iwCLL.
Up to approximately 12 months
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
大体时间：Up to approximately 13 months

AE and SAEs will be collected as part of this study at baseline and every clinical visit, until 30 days after the final dose of study treatment.
Up to approximately 13 months
Number of Participants Who Withdrew Prematurely from the Study
大体时间：Up to approximately 12 months

Participants who discontinued treatment before Cycle 12 Day 28 (cycle length= 28 days).
Up to approximately 12 months
Overall Survival (OS)
大体时间：Up to approximately 48 months

OS is defined as the time from the first study treatment to death from any cause.
Up to approximately 48 months
Progression-free Survival (PFS) as Determined by the Investigator According to iwCLL Guidelines
大体时间：Up to approximately 48 months

PFS is defined as the time from the first study treatment to the first occurrence of disease progression (PD) or death from any cause during study, whichever occurs first, as determined by the investigator according to the iwCLL.
Up to approximately 48 months
Event-free Survival (EFS) as Determined by the Investigator According to iwCLL Guidelines
大体时间：Up to approximately 48 months

EFS is defined as the time from the first study treatment to the first occurrence of PD, anti-leukemic treatment subsequent to the study treatment, or death from any cause during study, whichever occurs first, as determined by the investigator according to the iwCLL.
Up to approximately 48 months
Duration of Response (DOR) in Participants With CR/CRi or PR as Determined by the Investigator According to iwCLL Guidelines
大体时间：Up to approximately 12 months

DOR is defined as the time from the first occurrence of a documented objective response (i.e., CR/CRi or PR) to PD or death from any cause, whichever occurs first, as determined by the investigator according to the iwCLL.
Up to approximately 12 months
DOR in Participants With CR or CRi as Determined by the Investigator According to iwCLL Guidelines
大体时间：Up to approximately 12 months

DOR is defined as the time from the first occurrence of a documented objective response (i.e., CR or CRi ) to PD or death from any cause, whichever occurs first, as determined by the investigator according to the iwCLL.
Up to approximately 12 months
Time to Next CLL Treatment (TTNT)
大体时间：Up to approximately 12 months

TTNT is defined as the time from the first study treatment to the start of anti-leukemic treatment subsequent to the study treatment or death, whichever occurs first.
Up to approximately 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Genentech, Inc.

调查人员

  • 研究主任：Clinical Trials、Hoffmann-La Roche

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年8月9日

初级完成 (估计的)

2026年10月31日

研究完成 (估计的)

2030年1月31日

研究注册日期

首次提交

2024年7月23日

首先提交符合 QC 标准的

2024年7月23日

首次发布 (实际的)

2024年7月29日

研究记录更新

最后更新发布 (实际的)

2026年9月28日

上次提交的符合 QC 标准的更新

2026年9月25日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • ML45219

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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