Tests APG-2575 in adults with relapsed or refractory chronic lymphocytic leukemia
Tests the drug APG-2575 alone in adults whose leukemia has returned or not responded.
Plain-language title generated from the registry record
Registry title: Study of APG-2575 in Patients With Relapsed/Refractory CLL/SLL
Key facts
- Where
- Guangzhou, Haikou, Hanzhou, Nanchang, Suzhou, Tianjin, Wuhan, and Zhengzhou, ChinaSee the 11 sites
- Phase
- Phase 2
Where in China
- Nanfang Hospital of Southern Medical UniversityGuangzhou, ChinaTaking people
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaTaking people
- Zhujiang Hospital of Southern Medical UniversityGuangzhou, ChinaNot yet recruiting
- Hainan General HospitalHaikou, ChinaNot yet recruiting
- The First Affiliated Hospital of Zhejiang University School of MedicineHanzhou, ChinaNot yet recruiting
- The First Affilated Hospital of Nanchang UniversityNanchang, ChinaNot yet recruiting
- People's hospital of Jiangsu ProvinceSuzhou, ChinaNot yet recruiting
- The First Affilated Hospital of Soochow UniversitySuzhou, ChinaNot yet recruiting
- Institute of blood transfusion of Chinese Academy of Medical SciencesTianjin, ChinaNot yet recruiting
- Union Hospital medical college Huazhong University of Science and TechnologyWuhan, ChinaTaking people
- Henan Cancer HospitalZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ascentage Pharma Group Inc.
- Trial code
- NCT05147467
- Record updated
- 27 March 2026
- Original description
The purpose of this study is to assess the efficacy and safety of APG-2575 single agent in patients with relapsed/refractory CLL/SLL.Read full original descriptionShow less
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
The purpose of this study is to assess the efficacy and safety of APG-2575 single agent in patients with relapsed/refractory CLL/SLL.
Inclusion: 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 -2; 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.
Exclusion: 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; 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; Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:; 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.