APG-2575 treatment for patients with relapsed or refractory CLL/SLL

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

This study is testing a new oral medication called APG-2575 to see if it can help people with relapsed or hard-to-treat Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ascentage Pharma Group Inc. (Industry-sponsored)
• Drugs / interventions: immunotherapy
• Locations: 11 sites (Guangzhou, Guangdong and 10 other locations)
• Trial ID: NCT05147467 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of APG-2575, an oral medication, in patients suffering from relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). It is a single-arm, open-label, multi-center Phase II trial that aims to enroll approximately 75 participants who have previously failed or are intolerant to other treatments. Participants will take APG-2575 at a dose of 600mg once daily for 28-day cycles until the end of treatment criteria are met.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed relapsed or refractory CLL/SLL who have previously failed or are intolerant to BTK inhibitors and immunochemotherapy.

Not a fit: Patients who have not been treated with BTK inhibitors or immunochemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with limited treatment alternatives for CLL/SLL.

How similar studies have performed: Other studies have shown promising results with similar approaches in treating CLL/SLL, indicating potential for success.

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.

Where this trial is running

Guangzhou, Guangdong and 10 other locations

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

Study contacts

• Principal investigator: Jianyong Li, M.D. — The First Affiliated Hospital with Nanjing Medical University
• Study coordinator: Zi Chen, Doctor

Conditions Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; APG-2575; Lisaftoclax