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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• Nanfang Hospital of Southern Medical University
  Guangzhou, Guangdong, China Recruiting
• Henan Cancer Hospital
  Zhengzhou, Henan, China Recruiting
• Union Hospital medical college Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting
• Zhujiang Hospital of Southern Medical University
  Guangzhou, Guangdong, China Not yet recruiting
• Hainan General Hospital
  Haikou, Hainan, 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
• Email: Zi.Chen@ascentage.com
• Phone: +8618117275173

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.