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

Last updated: May 28, 2024
Sponsor: Ascentage Pharma Group Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Lymphocytic Leukemia, Chronic

Treatment

Rituximab

Fludarabine

Chlorambucil

Clinical Study ID

NCT06319456
APG2575CC301
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

  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 useeffective contraceptive measures throughout the treatment and for at least threemonths after the last dose of the study drug. Male patients must avoid donation fromthe first dose of the study drug to three months after the last dose of the studydrug.

  8. Female patients of childbearing potential have negative serum pregnancy test resultswithin 14 days prior to the first dose of the study drug.

  9. Patients must be able to understand and voluntarily sign an informed consent formapproved by the Ethics Committee (EC) before commencing any screening or studyspecific procedures.

  10. Must be willing and able to complete research procedures and follow-up examinations.

Exclusion

Exclusion Criteria:

  1. Any previous CLL specific treatment.

  2. Failure to fully recover adequately from prior surgical procedures at the discretionof the investigator. Patients who receive a major surgery within 28 days prior tothe 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 adverseeffect on the patient if he/she participates in the study, at the discretion of theinvestigator.

  5. Patients who require warfarin or other anticoagulants or active hemorrhage occurwithin 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 becomepregnant 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 enteraladministration.

  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 theinvestigator, make the patient unsuitable for the study.

Study Design

Total Participants: 344
Treatment Group(s): 6
Primary Treatment: Rituximab
Phase: 3
Study Start date:
April 07, 2024
Estimated Completion Date:
August 31, 2028

Study 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).

Connect with a study center

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui 233004
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • Henan Provincial Cancer Hospital

    Zhengzhou, Henan 450003
    China

    Active - Recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei 430023
    China

    Site Not Available

  • Hematology Hospital of the Chinese Academy of Medical Sciences

    Tianjin, Tianjin 300020
    China

    Active - Recruiting

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