A Single-arm, Pivotal Registration Phase II Study of the Efficacy and Safety of APG-2575 Monotherapy in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 11
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of APG-2575 single agent in patients with relapsed/refractory CLL/SLL.
详细描述
This is an single-arm, open-label, multi-center, pivotal registration Phase II study of efficacy and safety of APG-2575 as a single agent in relapsed/refractory CLL/SLL patients.
This study plans to enroll approximately 75 CLL/SLL subjects who have failed or are intolerant to prior immunochemotherapy and BTK inhibitor therapy. Eligible subjects will receive APG-2575 600mg, orally administered once daily (QD), within half an hour of a low-fat meal, for a cycle of 28 days. Participants will continue to accept APG - 2575 until the "end of treatment" that are consistent with the provisions in the solution of the termination of any specified standards.
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
- •Subjects who meet each of the following inclusion criteria are eligible to participate in this study:
- •Age ≥18 years old.
- •Pathologically confirmed CLL/SLL according to the 2018 revised IWCLL NCI-WG guidelines, subject with measurable lesions or splenomegaly due to CLL.
- •Expected survival is at least 12 weeks.
- •Refractory, recurrent, or intolerant to BTK inhibitors and immunochemotherapy,or first-line treatment with BTK inhibitors fails and is not suitable for immunochemotherapy.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -
- •Ability to understand and willingness to sign a written informed consent form approved by EC committee (the consent form must be signed by the patient prior to any screening or study-specific procedures).
- •Willingness and ability to comply with study procedures and follow-up examination.
排除标准
- •Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:
- •Prior history of allogeneic hematopoietic stem cell transplantation, adoptive cell immunotherapy or autologous hematopoietic stem cell transplantation within 24 months.
- •Failure to recover adequately, at the discretion of the investigator, from prior surgical procedures. Patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry.
- •Received Bcl-2 inhibitor treatment.
- •Invasive NHL transformation or central nervous system (CNS) involvement has occurred.
- •Pregnancy or lactation, or pregnancy is expected during the study period or within 3 months after the last administration of treatment.
- •Within 2 years before entering the study, the subject had a history of active malignant tumors other than CLL / SLL, except that:
- •Fully treated cervical carcinoma in situ;
- •Completely resected basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
- •Confinement and resection of previously cured malignancies (or other treatment).
- •Any other condition or circumstance that would, at the discretion of the investigator, make the patient unsuitable for participation in the study.
研究组 & 干预措施
APG-2575 single agent in Relapse/Refractory CLL/SLL
APG-2575 orally once daily at 600mg dose levels, every 28 days as a cycle.
干预措施: APG2575 (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to 9 months after the last subject enrolled.
ORR is defined by Complete Remission (CR)+ CR with incomplete marrow recovery (CRi) + Partial Remission (PR) (according to NCI-WG CLL(2018)) and by CR+PR ( according to Lugano (2014)).Response will be evaluated every 2 cycles (8 weeks) till complete treatment or one month after last dose.
次要结局
- Time To Progression (TTP)(Up to 9 months after the last subject enrolled.)
- Area under the plasma concentration versus time curve (AUC)(Up to 4 cycles (each cycle is 28 days).)
- Maximum plasma concentration (Cmax)(Up to 4 cycles (each cycle is 28 days).)
- Overall Survival (OS)(Up to 9 months after the last subject enrolled.)
- Progress Free Survival (PFS)(Up to 9 months after the last subject enrolled.)
- Time To Response (TTR)(Up to 9 months after the last subject enrolled.)
- Duration of Response (DOR)(Up to 9 months after the last subject enrolled.)
- the time of half absolute lymphocyte value (ALC)(Up to 9 months after the last subject enrolled.)
- Adverse events(Up to 9 months after the last subject enrolled.)