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
1 other identifier
interventional
75
1 country
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2021
Longer than P75 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2021
CompletedFirst Posted
Study publicly available on registry
December 7, 2021
CompletedStudy Start
First participant enrolled
December 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
March 27, 2026
March 1, 2026
4.9 years
November 24, 2021
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
ORR is defined by Complete Remission (CR)+ CR with incomplete marrow recovery (CRi) + Partial Remission (PR) (according to NCI-WG CLL(2018)) and by CR+PR ( according to Lugano (2014)).Response will be evaluated every 2 cycles (8 weeks) till complete treatment or one month after last dose.
Up to 9 months after the last subject enrolled.
Secondary Outcomes (9)
Progress Free Survival (PFS)
Up to 9 months after the last subject enrolled.
Time To Progression (TTP)
Up to 9 months after the last subject enrolled.
Time To Response (TTR)
Up to 9 months after the last subject enrolled.
Duration of Response (DOR)
Up to 9 months after the last subject enrolled.
Overall Survival (OS)
Up to 9 months after the last subject enrolled.
- +4 more secondary outcomes
Other Outcomes (2)
Minimal Residual Disease (MRD) negative rate
Up to 9 months after the last subject enrolled.
Bcl-2 expression
Up to 9 months after the last subject enrolled
Study Arms (1)
APG-2575 single agent in Relapse/Refractory CLL/SLL
EXPERIMENTALAPG-2575 orally once daily at 600mg dose levels, every 28 days as a cycle.
Interventions
APG-2575 orally once daily at 600mg dose levels, every 28 days as a cycle.
Eligibility Criteria
You may qualify if:
- 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:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
Hainan General Hospital
Haikou, Hainan, 570311, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
Union Hospital medical college Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
The First Affilated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
People's hospital of Jiangsu Province
Suzhou, Jiangsu, China
The First Affilated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Institute of blood transfusion of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 215127, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hanzhou, Zhejiang, 310003, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yifan Zhai, M.D., Ph.D.
Ascentage Pharma Group Inc.
- PRINCIPAL INVESTIGATOR
Jianyong Li, M.D.
The First Affiliated Hospital with Nanjing Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2021
First Posted
December 7, 2021
Study Start
December 28, 2021
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
March 27, 2026
Record last verified: 2026-03