A Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL.

July 27, 2026 updated by: Ascentage Pharma Group Inc.

A Global Multicenter Open Label Randomized Phase III Confirmatory Study of Lisaftoclax (APG-2575) in Combination With Acalabrutinib vs Immunochemotherapy in Patients With Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.

This is a global, multicenter, randomized, open-label, Phase III confirmatory study to investigate the efficacy and safety of Lisaftoclax (APG-2575) in combination with Acalabrutinib in patients with newly diagnosed CLL/SLL.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The patients with newly diagnosed CLL/SLL, who have met all required eligibility criteria, will be randomized to the investigational group (Lisaftoclax in combination with Acalabrutinib) or the control group (immunochemotherapy, CIT).

Study Type

Interventional

Enrollment (Estimated)

344

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • Not yet recruiting
        • the First Affiliated Hospital of Bengbu Medical College
        • Contact:
          • Yinghua Geng, M.D., Ph.D.
        • Principal Investigator:
          • Yinghua Geng, M.D., Ph.D.
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
          • Wenyu Li, M.D., Ph.D.
        • Principal Investigator:
          • Wenyu Li, M.D., Ph.D.
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital of Southern Medical University
        • Contact:
          • Xutao Guo, M.D., Ph.D.
        • Principal Investigator:
          • Xutao Guo, M.D., Ph.D.
      • Zhanjiang, Guangdong, China, 524013
        • Not yet recruiting
        • The Affiliated Hospital of Guangdong Medical University
        • Contact:
          • Yuming Zhang, M.D., PH.D.
        • Principal Investigator:
          • Yuming Zhang, M.D., PH.D.
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Provincial Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Keshu Zhou, M.D., Ph.D.
    • Hubei
      • Wuhan, Hubei, China, 430023
        • Not yet recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Jun Fang, M.D., Ph.D.
        • Principal Investigator:
          • Jun Fang, M.D., Ph.D.
    • Hunan
      • Changsha, Hunan, China, 410031
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Contact:
          • Yajun Li, M.D., Ph.D.
        • Principal Investigator:
          • Yajun Li, M.D., Ph.D.
      • Changsha, Hunan, China, 545001
        • Not yet recruiting
        • The Second Xiangya Hospital of Center South University
        • Contact:
          • Honglin Peng, M.D., Ph.D.
        • Principal Investigator:
          • Honglin Peng, M.D., Ph.D.
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200065
        • Not yet recruiting
        • Tongji Hospital of Tongji University
        • Contact:
          • Jianfei Fu, M.D., Ph.D.
        • Principal Investigator:
          • Jianfei Fu, M.D., Ph.D.
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300020
        • Recruiting
        • Hematology Hospital of the Chinese Academy of Medical Sciences
        • Principal Investigator:
          • Lugui Qiu, M.D., Ph.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

  1. CLL/SLL must be diagnosed according to the IWCLL NCI-WG Guidelines (2018 edition) and meet at least one of the criteria requiring treatment.
  2. With a measurable disease.
  3. ECOG score 0-2.
  4. QTcF interval: ≤450ms in males, ≤470ms in females.
  5. Adequate bone marrow function independent of growth factor support.
  6. Adequate liver, kidney and coagulation function.
  7. Males and females of childbearing potential, and their partners voluntarily use effective contraceptive measures throughout the treatment and for at least three months after the last dose of the study drug. Male patients must avoid donation from the first dose of the study drug to three months after the last dose of the study drug.
  8. Female patients of childbearing potential have negative serum pregnancy test results within 14 days prior to the first dose of the study drug.
  9. Patients must be able to understand and voluntarily sign an informed consent form approved by the Ethics Committee (EC) before commencing any screening or study specific procedures.
  10. Must be willing and able to complete research procedures and follow-up examinations.

Exclusion Criteria:

  1. Any previous CLL specific treatment.
  2. Failure to fully recover adequately from prior surgical procedures at the discretion of the investigator. Patients who receive a major surgery within 28 days prior to the first dose of the study drug or who receive a minor surgery (excluding biopsy) within 14 days prior to the initiation of the study.
  3. Presence of significant cardiovascular disease within 6 months prior to study entry.
  4. A history of significant kidney, neurological, psychiatric, pulmonary, endocrine, metabolic, immune, cardiovascular, or liver disease, which will have an adverse effect on the patient if he/she participates in the study, at the discretion of the investigator.
  5. Patients who require warfarin or other anticoagulants or active hemorrhage occur within 2 months before study entry.
  6. Known to have hypersensitivity to the drug ingredient or its analogues.
  7. Pregnant or lactating female patients and patients who are expected to become pregnant during the study period or within 3 months after the last dose.
  8. Patients who have history of other active malignant tumor other than CLL/SLL within 3 years before study entry.
  9. With a malabsorption syndrome or other conditions unsuitable for enteral administration.
  10. Other clinically significant uncontrolled symptoms.
  11. With primary active autoimmune disease and connective tissue disease.
  12. Any other circumstances or conditions that would, at the discretion of the investigator, make the patient unsuitable for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lisaftoclax (APG-2575) combined with Acalabrutinib
Lisaftoclax (APG-2575) 600 mg daily plus acalabrutinib 100 mg twice daily for a fixed duration of treatment up to 18 cycles.
Drug: Lisaftoclax (APG-2575)
QD, oral administration, every 28 days for a dosing cycle.
Drug: Acalabrutinib
BID, oral administration, every 28 days for a dosing cycle.
Active Comparator: Immunochemotherapy regimens

FCR:

Fludarabine: intravenously infused at 25 mg/m2 /d on Days 1 to 3 of Cycles 1-6 cyclophosphamide: intravenously infused at 250 mg/m2 /d on Days 1 - 3 of Cycles 1 - 6; rituximab: intravenously infused at 375 mg/m2 on C1D1, and at 500 mg/m2 on Day 1 of Cycles 2 - 6. F

or

R-Clb: Chlorambucil: orally administrated at 0.5 mg/kg on Days 1 and 15 of Cycles 1-6; rituximab: intravenously infused at 375 mg/m2 on C1D1, and at 500 mg/m2 on Day 1 of Cycles 2 - 6.
Drug: Fludarabine
Every 28 days for a treatment cycle, administration of 6 cycles.
Drug: Cyclophosphamide，CTX
Every 28 days for a treatment cycle, administration of 6 cycles.
Drug: Rituximab
Every 28 days for a treatment cycle, administration of 6 cycles.
Drug: Chlorambucil
Every 28 days for a treatment cycle, administration of 6 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progress Free Survival (PFS)
Time Frame: Up to 1 year
PFS is defined as the time from randomization to disease progression(PD) or death from any cause.
Up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to 1 year
ORR is defined as the proportion of patients who have achieved CR, CRi or PR.
Up to 1 year
Minimal Residual Disease (MRD) negativity rate
Time Frame: Up to 1 year
To observe the proportion of patients with MRD negativity in bone marrow, peripheral blood, either or both.
Up to 1 year
Safety evaluation based on the adverse event concurrence
Time Frame: Up to 1 year
Number of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) will be evaluated.
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascentage Pharma Group Inc.

Investigators

  • Principal Investigator: Lugui Qiu, M.D., Ph.D., Hematology Hospital of the Chinese Academy of Medical Sciences
  • Principal Investigator: Keshu Zhou, M.D., Ph.D., Henan province Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2024

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

July 28, 2026

Last Update Submitted That Met QC Criteria

July 27, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APG2575CC301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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