This study is to assess the efficacy and safety of Lisaftoclax for prevention of DS in APL patients undergoing ATRA/ATO induction regimen.
1. Patients aged ≥ 16 years old.
2. Confirmed diagnosis of acute promyelocytic leukemia (APL) by morphology, flow cytometry, and cytogenetics/molecular testing.
3. ECOG performance status 0-2.
Serum creatinine ≤ 1.5 × ULN
1. Concurrent participation in another interventional clinical trial.
2. History of other malignancies within the past 5 years (except cured basal cell carcinoma or in situ cervical cancer).
3. Severe uncontrolled infection or other serious underlying diseases that may interfere with study treatment or follow-up.
4. Known hypersensitivity to lisaftoclax, ATRA, ATO, or any components of the study regimen.
Single group
Lisaftoclax (APG-2575)
DrugDescription: 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.
the rate of Differentiation Syndrom
DS, known as retinoic acid syndrome, is a severe complication of ATRA or ATO during the differentiation of promyelocytes. Signs of DS are presented as fever, weight gain, hypertension, dyspnoea, radiographic opacities, peripheral edema and acute renal failure.
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