A Phase 2, Open-Label, Randomized Study Evaluating the Efficacy and Safety of 3 Doses of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Who Previously Received Treatment With a Covalent Bruton Tyrosine Kinase Inhibitor
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 249
- 试验地点
- 253
- 主要终点
- Overall Response Rate
研究概览
简要总结
The main purpose of Part 1 of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhibitor. The purpose of Part 2 of this study is to evaluate pirtobrutinib monotherapy in participants with treatment-naïve CLL/SLL with 17p deletions. Participation in Part 1 is expected to last approximately 3 years. Participation in Part 2 is expected to last up to 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Part 2 is non-randomized
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
- •Have confirmed diagnosis of CLL/SLL as defined by iwCLL 2018 criteria.
- •Part 1: Have received prior CLL/SLL treatment
- •Have received at least 1, but not more than 3 lines of prior treatment for CLL/SLL
- •Have received a covalent BTK inhibitor
- •Part 2: Have received no prior treatment for CLL/SLL
- •Part 1 - Known 17p deletion status (positive or negative)
- •Part 2 - Must have 17p deletion (positive)
- •Have a requirement for therapy consistent with iwCLL 2018 criteria for initiation of therapy
- •Capable of swallowing oral study medication.
- •Have an Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0 to 2.
排除标准
- •Have received prior treatment with a BTK degrader or a noncovalent BTK inhibitor
- •Have a history of greater than or equal to (>=) Grade 3 bleeding due to treatment with a BTK inhibitor
- •Have known or suspected Richter's transformation
- •Have known or suspected history of central nervous system involvement by CLL/SLL
- •Previous or concurrent cancer distinct from CLL/SLL within 3 years before randomization. Exceptions may occur with documented sponsor approval. Examples include:
- •nonmelanoma skin cancer or lentigo malignant melanoma
- •cervical carcinoma in situ
- •localized prostate cancer undergoing active surveillance, and
- •localized (for example, lymph node negative) breast cancer with no evidence of active disease present for more than 3 years. Individual may be receiving adjuvant hormonal therapy
研究组 & 干预措施
Pirtobrutinib Standard Dose (Dose 1)-Part 1
Pirtobrutinib administered orally.
干预措施: Pirtobrutinib (Drug)
Pirtobrutinib Dose 2-Part 1
Pirtobrutinib administered orally.
干预措施: Pirtobrutinib (Drug)
Pirtobrutinib Dose 3-Part 1
Pirtobrutinib administered orally.
干预措施: Pirtobrutinib (Drug)
Pirtobrutinib Standard Dose-Part 2
Pirtobrutinib administered orally.
干预措施: Pirtobrutinib (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: Baseline up to 3 years
Overall response rate is defined as the proportion of participants who achieve the best overall response at or before the initiation of subsequent anticancer therapy of CR, CRi, nPR, or PR. ORR will be assessed using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 response criteria.
次要结局
- Duration of Response(Baseline up to 3 years)