Study of APG-2575 in Patients With Relapsed/Refractory CLL/SLL

Recruiting now · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

In brief

The purpose of this study is to assess the efficacy and safety of APG-2575 single agent in patients with relapsed/refractory CLL/SLL.

Key facts

Study ID

NCT05147467

Run by

Ascentage Pharma Group Inc.

People needed

75

Starts

2021-12-28

Expected to finish

2027-12-01

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)
• Nanfang Hospital of Southern Medical University — Guangzhou, Guangdong, China (enrolling)
• Henan Cancer Hospital — Zhengzhou, Henan, China (enrolling)
• Union Hospital medical college Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
• Institute of blood transfusion of Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality, China
• The First Affiliated Hospital of Zhejiang University School of Medicine — Hanzhou, Zhejiang, China
• The First Affilated Hospital of Soochow University — Suzhou, Jiangsu, China
• People's hospital of Jiangsu Province — Suzhou, Jiangsu, China
• Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China
• The First Affilated Hospital of Nanchang University — Nanchang, Jiangxi, China
• Hainan General Hospital — Haikou, Hainan, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.