Status:
ENROLLING_BY_INVITATION
Venetoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
Acute Promyelocytic Leukemia
Eligibility:
All Genders
Phase:
PHASE2
PHASE3
Brief 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 Criteria
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
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT06544109
Start Date
August 1 2023
End Date
August 1 2028
Last Update
August 9 2024
Active Locations (1)
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1
Qiu huiying
Suzhou, Jiangsu, China, 215006