A Global Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL.
NCT ID: NCT06319456
Last Updated: 2024-05-29
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
PHASE3
344 participants
INTERVENTIONAL
2024-04-07
2028-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lisaftoclax (APG-2575) combined with Acalabrutinib
Lisaftoclax (APG-2575)
QD, oral administration, every 28 days for a dosing cycle.
Acalabrutinib
BID, oral administration, every 28 days for a dosing cycle.
Immunochemotherapy regimens
Fludarabine
Every 28 days for a treatment cycle, administration of 6 cycles.
Cyclophosphamide，CTX
Every 28 days for a treatment cycle, administration of 6 cycles.
Rituximab
Every 28 days for a treatment cycle, administration of 6 cycles.
Chlorambucil
Every 28 days for a treatment cycle, administration of 6 cycles.
Interventions
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Lisaftoclax (APG-2575)
QD, oral administration, every 28 days for a dosing cycle.
Acalabrutinib
BID, oral administration, every 28 days for a dosing cycle.
Fludarabine
Every 28 days for a treatment cycle, administration of 6 cycles.
Cyclophosphamide，CTX
Every 28 days for a treatment cycle, administration of 6 cycles.
Rituximab
Every 28 days for a treatment cycle, administration of 6 cycles.
Chlorambucil
Every 28 days for a treatment cycle, administration of 6 cycles.
Eligibility Criteria
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Exclusion Criteria
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.
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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Lugui Qiu, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Hematology Hospital of the Chinese Academy of Medical Sciences
Keshu Zhou, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Henan Province Cancer Hospital
Locations
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Henan Provincial Cancer Hospital
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Yinghua Geng, M.D., Ph.D.
Role: primary
Wenyu Li, M.D., Ph.D.
Role: primary
Xutao Guo, M.D., Ph.D.
Role: primary
Jun Fang, M.D., Ph.D.
Role: primary
Other Identifiers
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APG2575CC301
Identifier Type: -
Identifier Source: org_study_id
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