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Study of APG-2575 in Patients With Relapsed/Refractory CLL/SLL
NCT05147467 · Ascentage Pharma Group Inc.
In plain English
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Official title
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
About this study
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.
Eligibility criteria
Inclusion Criteria:
Subjects who meet each of the following inclusion criteria are eligible to participate in this study:
1. Age ≥18 years old.
2. Pathologically confirmed CLL/SLL according to the 2018 revised IWCLL NCI-WG guidelines, subject with measurable lesions or splenomegaly due to CLL.
3. Expected survival is at least 12 weeks.
4. Refractory, recurrent, or intolerant to BTK inhibitors and immunochemotherapy,or first-line treatment with BTK inhibitors fails and is not suitable for immunochemotherapy.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -2.
6. 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).
7. Willingness and ability to comply with study procedures and follow-up examination.
Exclusion Criteria:
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:
1. Prior history of allogeneic hematopoietic stem cell transplantation, adoptive cell immunotherapy or autologous hematopoietic stem cell transplantation within 24 months.
2. 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.
3. Received Bcl-2 inhibitor treatment.
4. Invasive NHL transformation or central nervous system (CNS) involvement has occurred.
5. Pregnancy or lactation, or pregnancy is expected during the study period or within 3 months after the last administration of treatment.
6. 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).
7. Any other condition or circumstance that would, at the discretion of the investigator, make the patient unsuitable for participation in the study.
Study design
Enrollment target: 75 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-12-28
Estimated completion: 2027-12
Last updated: 2026-03-27
Interventions
Drug: APG2575
Primary outcomes
- • Objective Response Rate (ORR) (Up to 9 months after the last subject enrolled.)
Sponsor
Ascentage Pharma Group Inc. · industry
Contacts & investigators
ContactZi Chen, Doctor · contact · Zi.Chen@ascentage.com · +8618117275173
ContactMin Yu, Doctor · contact · Min.Yu@ascentage.com · +8615000679101
InvestigatorYifan Zhai, M.D., Ph.D. · study_director, Ascentage Pharma Group Inc.
InvestigatorJianyong Li, M.D. · principal_investigator, The First Affiliated Hospital with Nanjing Medical University
All locations (11)
Sun Yat-sen University Cancer CenterRecruiting
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical UniversityNot Yet Recruiting
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical UniversityRecruiting
Guangzhou, Guangdong, China
Hainan General HospitalNot Yet Recruiting
Haikou, Hainan, China
Henan Cancer HospitalRecruiting
Zhengzhou, Henan, China
Union Hospital medical college Huazhong University of Science and TechnologyRecruiting
Wuhan, Hubei, China
The First Affilated Hospital of Soochow UniversityNot Yet Recruiting
Suzhou, Jiangsu, China
People's hospital of Jiangsu ProvinceNot Yet Recruiting
Suzhou, Jiangsu, China
The First Affilated Hospital of Nanchang UniversityNot Yet Recruiting
Nanchang, Jiangxi, China
Institute of blood transfusion of Chinese Academy of Medical SciencesNot Yet Recruiting
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Zhejiang University School of MedicineNot Yet Recruiting
Hanzhou, Zhejiang, China