Study of APG2575 Single Agent and Combination Therapy in Patients With Relapsed/Refractory CLL/SLL
NCT ID: NCT04494503
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
123 participants
INTERVENTIONAL
2020-08-31
2025-12-31
Brief Summary
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Detailed Description
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This study consists of two parts: The first part is the APG-2575 single agent cohort expansion. The cohort expansion will be conducted at three dose levels of 400 mg, 600 mg, and 800 mg. And up to 15 patients are planned to be enrolled at each dose level.
The second part contains two arms: APG-2575 combined with rituximab (Arm A) and APG-2575 combined with ibrutinib (Arm B). Both the two arms consist of two stages: dose escalation stage (first stage) and dose expansion stage (second stage). The first stage is the study of APG-2575 dose escalation combined with rituximab/ibrutinib. APG-2575 dose escalates according to the standard 3+3 design, the initial dose is 200mg, the dose of APG-2575 will be increased in subsequent levels, to 400mg, 600mg, 800mg respectively. The second stage is the MTD/RP2D expansion stage. Once the respective MTD/RP2D of arms A and B is determined, up to 15 subjects in each MTD/RP2D dose level would be enrolled.
APG-2575 will be administered orally, once daily for consecutive 4 weeks as one cycle.
Rituximab, on cycle 1 day 8(C1D8): 375mg/m2; on cycles 2-6 day l(C2-6D1): 500mg/m2, a total of six infusions.
Ibrutinib 420 mg will be orally administered daily beginning from cycle 1 day 8 and continuously thereafter, every 4 weeks as a cycle.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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APG-2575 single agent in Relapse/Refractory CLL/SLL
APG-2575 orally once daily at 400mg, 600mg, 800mg dose levels respectively, every 28 days as a cycle.
APG-2575
APG-2575 orally once daily, every 28 days as a cycle.
APG-2575+Rituximab in Relapse/Refractory CLL/SLL
Stage 1:APG-2575 orally once daily starting from 200mg and will be increased in subsequent cohorts to 400mg, 600mg, 800mg. Rituximab 375mg/m2 ivgtt on C1D8 and 500mg/m2 ivgtt on C2-6D1. Every 28 days as a cycle.
Stage 2: APG-2575 MTD/RP2D combined with rituximab. Every 28 days as a cycle.
APG-2575
APG-2575 orally once daily, every 28 days as a cycle.
Rituximab
Rituximab 375mg/m2 ivgtt on C1D8 and 500mg/m2 ivgtt on C2-6D1.
APG-2575+ibrutinib in Relapse/Refractory CLL/SLL
Stage 1: APG-2575 orally once daily starting from 200mg and will be increased in subsequent cohorts to 400mg, 600mg, 800mg.Ibrutinib 420mg orally once daily during C1D8-28 and following cycles. Every 28 days as a cycle.
Stage 2: APG-2575 MTD/RP2D combined with ibrutinib. Every 28 days as a cycle.
APG-2575
APG-2575 orally once daily, every 28 days as a cycle.
Ibrutinib
Ibrutinib 420mg orally once daily during C1D8-28 and following cycles.
Interventions
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APG-2575
APG-2575 orally once daily, every 28 days as a cycle.
Rituximab
Rituximab 375mg/m2 ivgtt on C1D8 and 500mg/m2 ivgtt on C2-6D1.
Ibrutinib
Ibrutinib 420mg orally once daily during C1D8-28 and following cycles.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis as relapsed/refractory chronic lymphocytic leukemia/ small lymphocytic lymphoma according to the IWCLL NCI-WG guidelines revised in 2008.
3. Through radiological assessment, subjects with a lymph node length ≥ 10 cm require prior approval from the sponsor before enrollment.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -1.
5. QTcF interval ≤450ms in males, and ≤470ms in females.
6. Adequate bone marrow function independent of growth factor and transfusion.
7. Adequate renal and liver function.
8. Willingness by males, female patients of child bearing potential, and their partners to use contraception by effective methods throughout the treatment period and for at least three months following the last dose of study drug.
9. Pregnancy test results of serum samples obtained within 14 days before the first study drug administration in fertile female subjects were negative; If the serum pregnancy test results obtained are\> 7 days from the first administration, urine sample obtained before the first study dose of study drug must be negative.
10. Male subjects must avoid sperm donation throughout the treatment period and for at least three months following the last dose of study drug.
11. 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).
12. Willingness and ability to comply with study procedures and follow-up examination.
Exclusion Criteria
2. Monoclonal antibody therapy against CLL was adopted within 4 weeks prior to the first dose of the study drug.
3. Receive any of the following treatments within 14 days or 5x half-life before the first dose of study drug, or clinically significant adverse reactions / toxicities due to previous treatments have not recovered to ≤ Grade 1: Anti-tumor therapies include chemotherapy, radiotherapy, anti-tumor steroid treatment, anti-tumor Chinese medicine treatment; investigational treatment, including targeted small molecule drugs.
4. Use the following drugs within 14 days before the first dose of study drug: moderately potent CYP3A inhibitors such as fluconazole, ketoconazole and clarithromycin; moderately potent CYP3A inducers such as rifampin, carbamazepine, phenytoin And St. John's wort.
5. 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.
6. Received Bcl-2 inhibitor treatment.
7. Invasive NHL transformation or central nervous system (CNS) involvement. has occurred.
8. Cardiovascular disease of grade ≥2 (New York Heart Association Class).
9. A significant history of renal, neurological, psychiatric, pulmonary, endocrine, metabolic, immune, cardiovascular or liver disease. The investigator believes that participating in this study will have an adverse effect on him / her. For subjects requiring intervention for any of the above diseases in the past 6 months, the investigator and the sponsor must discuss.
10. Warfarin or other anticoagulants is required.
11. Known to be allergic to study drug ingredients or their analogues.
12. Pregnancy or lactation, or pregnancy is expected during the study period or within 3 months after the last administration of treatment.
13. Within 3 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).
14. Has malabsorption syndrome or other conditions that are not suitable for enteral administration.
15. Uncontrolled other clinically significant symptoms, including but not limited to: uncontrolled systemic infections (viruses, bacteria, or fungi), including but not limited to known hepatitis B virus (HBV) surface antigens and DNA positive(HBV-DNA≥2000copies/mL or ≥500IU/mL); Hepatitis C virus (HCV) antibody positive or RNA positive; human immunodeficiency virus (HIV) antibody positive; Febrile neutropenia occured within 1 week before administration.
16. Primary active autoimmune diseases and connective tissue diseases, such as active and uncontrolled primary autoimmune hemocytopenia, including autoimmune hemolytic anemia (AIHA) and primary immune thrombocytopenia (ITP).
17. Any other condition or circumstance that would, at the discretion of the investigator, make the patient unsuitable for participation in the study.
18 Years
ALL
No
Sponsors
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Ascentage Pharma Group Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Henan Provincial Oncology Hospital
Zhenzhou, Henan, China
Union Hospital medical college Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangya Hospital Central South University
Changsha, Hunan, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
The First affiliated hospital of Soochow University
Suzhou, Jiangsu, China
The First affiliated hospital of Nanchang University
Nanchang, Jiangxi, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
The First Bethune Hospital of Jilin University
Hangzhou, Zhejiang, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Hongmei Jing, M.D.
Role: primary
Yi Gong, M.D., Ph.D.
Role: primary
Ru Feng Professor
Role: backup
Hong Cen, Doctor
Role: primary
Jishi Wang, Doctor
Role: primary
Lihong Liu, M.D.
Role: primary
Keshu Zhou, Doctor
Role: primary
Guohui Cui, M.D.
Role: primary
Xielan Zhao, M.D.
Role: primary
Xiaoping Zhang, M.D.
Role: primary
Li Professor
Role: primary
Fangfang LV, Master
Role: primary
Dongmei Ji, Doctor
Role: backup
Peng Liu, M.D.
Role: primary
Shuhua Yi, Doctor
Role: primary
Jie Jin, Doctor
Role: primary
Wenbin Qian, Doctor
Role: primary
Other Identifiers
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APG2575CC101
Identifier Type: -
Identifier Source: org_study_id
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