A Phase 2 Study of Venetoclax Monotherapy in Japanese Subjects With Relapsed or Refractory Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 14
- 试验地点
- 35
- 主要终点
- Number of Participants with Major Response
研究概览
简要总结
Lymphoplasmacytic Lymphoma (LPL) is a rare type of low-grade B-cell lymphoma. The purpose of this study is to assess the change in disease activity of adult participants with relapsed or refractory Waldenström macroglobulinemia(WM)/LPL receiving venetoclax.
Venetoclax is being investigated in the treatment of WM/LPL. Participants will receive oral venetoclax at doses ramping up to the target dose, as part of treatment. Approximately 14 adult participants with WM/LPL will be enrolled in the study at approximately 20 sites in Japan.
Participants will receive oral venetoclax at doses ramping up to the target dose. The total study duration is approximately 28 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.
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
- •Documented diagnosis of Waldenström macroglobulinemia(WM) /lymphoplasmacytic lymphoma (LPL) according to the 5th edition of the World Health Organization (WHO) classification and/or documented clinicopathological diagnosis of WM in accordance with the consensus panel of the second International Workshop on WM (IWWM).
- •At least one prior standard therapy for WM/LPL.
- •Measurable disease, defined as follows:
- •WM type LPL population: Immunoglobulin M (IgM) >= 500 mg/dL per central laboratory (approximately 14 participants)
- •Non-IgM type LPL population or IgM < 500 mg/dL: A measurable node having a longest diameter (LDi) greater than 1.5 cm, or a measurable extranodal disease having a LDi greater than 1.0 cm, according to contrast-enhanced computed tomography (CT) scan. (up to 2 participants)
- •Requires systemic anti-cancer treatment for WM/LPL, according to the investigator.
- •Eastern Cooperative Oncology Group Performance Status < = 2
- •Adequate organ and bone marrow function
排除标准
- •History of prior exposure to venetoclax or BCL-2 targeted therapy.
- •Uncontrolled active systemic infection.
- •Known bleeding disorders (e.g., hemophilia).
研究组 & 干预措施
Venetoclax Monotherapy
Participants will receive venetoclax at doses ramping up to the target dose, as part of the approximately 28 month study duration.
干预措施: Venetoclax (Drug)
结局指标
主要结局
Number of Participants with Major Response
时间窗: Up to Approximately 28 Months
Major response is defined as participants with a best overall response of complete response (CR), very good partial response (VGPR) or partial response (PR) per independent review committee (IRC) assessment according to International Workshop on Waldenstrom macroglobulinemia (WM) (IWWM)-11 criteria in participants with Immunoglobulin M (IgM) \>= 500 mg/dL at screening.
Number of Participants with Major Response in participants with IgM >= 500 mg/dL
时间窗: Up to Approximately 28 Months
Major response is defined as participants with a best overall response of CR, VGPR or PR per IRC assessment according to IWWM-11.
次要结局
- Progression-Free Survival (PFS)(Up to Approximately 28 Months)
- Overall Survival (OS)(Up to Approximately 28 Months)
- Overall Response (OR)(Up to Approximately 28 Months)
- Duration of Response (DOR)(Up to Approximately 28 Months)
- Time to Next Treatment (TTNT)(Up to Approximately 28 Months)