RecruitingPhase 2NCT05147467

Study of APG-2575 in Patients With Relapsed/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


Sponsor

Ascentage Pharma Group Inc.

Enrollment

75 participants

Start Date

Dec 28, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria10

  • 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.

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Interventions

DRUGAPG2575

APG-2575 orally once daily at 600mg dose levels, every 28 days as a cycle.


Locations(11)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Hainan General Hospital

Haikou, Hainan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Union Hospital medical college Huazhong University of Science and Technology

Wuhan, Hubei, China

The First Affilated Hospital of Soochow University

Suzhou, Jiangsu, China

People's hospital of Jiangsu Province

Suzhou, Jiangsu, China

The First Affilated Hospital of Nanchang University

Nanchang, Jiangxi, China

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

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NCT05147467


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