Venetoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients

Venetoclax 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 venetoclax for prevention of DS in APL patients undergoing ATRA/ATO induction regimen.

Inclusion Criteria:

1. Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent.
2. patients must have confirmation of APL by WHO criteria, previously untreated, and eligible for treatment with intensive chemotherapy as defined by the following: Cardiac history of congestive heart failure requiring treatment or ejection fraction ≤ 50% or chronic stable angina. Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume during the first second (FEV1) ≤ 65%. Creatinine clearance < 45 mL/min. Moderate hepatic impairment with total bilirubin > 1.5 × ULN. Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy.

Exclusion Criteria:

1. Patient is ineligible for treatment with intensive chemotherapy
2. Patient with active infection not controlled, active bleeding from vital organs
3. Patient with history of clinically significant drug or alcohol abuse that would adversely affect evaluation in this study