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Lisaftoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients
Sponsor: The Affiliated People's Hospital of Ningbo University
Summary
This study is to assess the efficacy and safety of Lisaftoclax for prevention of DS in APL patients undergoing ATRA/ATO induction regimen.
Official title: Lisaftoclax for Prevention of Differentiation Syndrom (DS) in Acute Promyelocytic Leukemia (APL) Patients : An Open-lable, Single-arm, Multicenter, Phase Ⅱ Clinical Trail
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-07
Completion Date
2028-12
Last Updated
2026-06-30
Healthy Volunteers
No
Conditions
Interventions
Lisaftoclax (APG-2575)
Description: Newly diagnosed APL patients receive standard induction therapy with oral ATRA 25 mg/m²/day and intravenous ATO 0.16 mg/kg/day. Lisaftoclax (APG-2575) is given for DS prophylaxis in patients with peripheral WBC count \>2.0×10⁹/L or ≥24-hour 2-fold WBC elevation. Lisaftoclax can only be initiated 24 hours after ATRA/ATO induction initiation. Dosing and Escalation: Lisaftoclax starts at 50 mg QD. Dose may be escalated to 100 mg QD, with a maximum dose of 100 mg twice daily (bid) based on patient tolerability. Monitoring and Interruption: Daily peripheral blood count monitoring is required during Lisaftoclax treatment. Lisaftoclax must be immediately withheld if the WBC count declines for two consecutive days. Protocol-defined dexamethasone or ruxolitinib will be administered for suspected DS during induction therapy.