Lisaftoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients

Lisaftoclax for Prevention of Differentiation Syndrom (DS) in Acute Promyelocytic Leukemia (APL) Patients : An Open-lable, Single-arm, Multicenter, Phase Ⅱ Clinical Trail

This study is to assess the efficacy and safety of Lisaftoclax for prevention of DS in APL patients undergoing ATRA/ATO induction regimen.

Inclusion Criteria:

• 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.
• 4. Adequate organ function:
• Serum creatinine ≤ 1.5 × ULN
• Total bilirubin ≤ 2 × ULN
• AST/ALT ≤ 3 × ULN
• 5. Able to understand and sign the informed consent form.

Exclusion Criteria:

• 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.
• 5. Pregnant or breastfeeding women.