Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT04494503

Study of APG2575 Single Agent and Combination Therapy in Patients With Relapsed/Refractory CLL/SLL

Led by Ascentage Pharma Group Inc. · Updated on 2025-04-16

123

Participants Needed

18

Research Sites

274 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to assess the safety, pharmacokinetic, pharmacodynamic and efficacy of APG-2575 single agent and in combination with other therapeutic agents in patients with relapsed/refractory CLL/SLL.

CONDITIONS

Official Title

Study of APG2575 Single Agent and Combination Therapy in Patients With Relapsed/Refractory CLL/SLL

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

Subjects who meet each of the following inclusion criteria are eligible to participate in this study:

  1. Age ≥18 years old.
  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.
Not Eligible

You will not qualify if you...

Patients 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 within 24 months or autologous hematopoietic stem cell transplantation within 12 months.

  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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 18 locations

1

Peking University Third Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

2

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Actively Recruiting

3

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Actively Recruiting

4

Guangxi Medical University Affiliated Tumor Hospital

Nanning, Guangxi, China

Actively Recruiting

5

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Actively Recruiting

6

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Actively Recruiting

7

Henan Provincial Oncology Hospital

Zhenzhou, Henan, China

Actively Recruiting

8

Union Hospital medical college Huazhong University of Science and Technology

Wuhan, Hubei, China

Actively Recruiting

9

Xiangya Hospital Central South University

Changsha, Hunan, China

Actively Recruiting

10

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Actively Recruiting

11

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

Actively Recruiting

12

The First affiliated hospital of Soochow University

Suzhou, Jiangsu, China

Actively Recruiting

13

The First affiliated hospital of Nanchang University

Nanchang, Jiangxi, China

Actively Recruiting

14

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Actively Recruiting

15

Fudan University Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Not Yet Recruiting

16

Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Actively Recruiting

17

The First Bethune Hospital of Jilin University

Hangzhou, Zhejiang, China

Actively Recruiting

18

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Actively Recruiting

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Research Team

J

Jianyong Li, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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