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Trial Title:
Venetoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients
NCT ID:
NCT06544109
Condition:
Acute Promyelocytic Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Promyelocytic, Acute
Venetoclax
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
venetoclax
Description:
patients in whom the WBC counts increased to more than 2 × 109/L received Venetoclax
Arm group label:
Arm Description:the Venatoclax regimen to prevent DS
Summary:
This study is to assess the efficacy and safety of venetoclax for prevention of DS in APL
patients undergoing ATRA/ATO induction regimen.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Qiu huiying
Address:
City:
Suzhou
Zip:
215006
Country:
China
Start date:
August 1, 2023
Completion date:
August 1, 2028
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06544109
