By InvitationPhase 2/3

Venetoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients

China98 participantsStarted 2023-08-01

Plain-language summary

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

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. 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.

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

the rate of differential symdrom

Timeframe: the induction regimen (21 days to 28 days)

NCT IDNCT06544109

SponsorThe First Affiliated Hospital of Soochow University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-01