Tests venetoclax to help prevent differentiation syndrome in acute promyelocytic leukemia
Tests venetoclax in patients with acute promyelocytic leukemia receiving ATRA and ATO treatment.
Plain-language title generated from the registry record
Registry title: Venetoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients
Key facts
- Where
- Suzhou, ChinaSee the site
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with acute promyelocytic leukemia (APL) who have not been treated yet and will receive ATRA/ATO treatment. It tests venetoclax to help prevent differentiation syndrome.
- Sex
- All sexes can join.
- Disease stage
- Acute promyelocytic leukemia (APL) confirmed by WHO criteria.
- Earlier treatment
- Previously untreated for APL.
Main reasons for not taking part
- Cannot have intensive chemotherapy
- Active infection that is not controlled
- Active bleeding from vital organs
- Clinically significant drug or alcohol abuse
Read by machine on 12 November 2026.
Where in China
- Qiu huiyingSuzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- The First Affiliated Hospital of Soochow University
- Trial code
- NCT06544109
- Record updated
- 9 August 2024
- Original description
This study is to assess the efficacy and safety of venetoclax for prevention of DS in APL patients undergoing ATRA/ATO induction regimen.Read full original descriptionShow less
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: 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.
Exclusion: 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.