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Clinical Trials in China / NCT06544109
Enrolling by invitation Phase 2/3

Venetoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients

NCT06544109 · tracked via the Priya Life Science China tracker
Sponsor
The First Affiliated Hospital of Soochow University
Phase
Phase 2/3
Started
2023-08-01
Last updated
2024-08-09

Condition(s) studied

Acute Promyelocytic Leukemia

Investigational drug(s) / intervention(s)

venetoclax →

venetoclax: patients in whom the WBC counts increased to more than 2 × 109/L received Venetoclax

Study summary

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

Eligibility

Sex
ALL
Min age
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Qiu huiying Suzhou Jiangsu

On this site

📄 Venclexta (venetoclax) drug profile →

More The First Affiliated Hospital of Soochow University trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06544109 on ClinicalTrials.gov ↗ ← All trials in China