Acute Promyelocytic Leukemia
Conditions
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.
Interventions
DRUGvenetoclax
patients in whom the WBC counts increased to more than 2 × 109/L received Venetoclax
Sponsors
The First Affiliated Hospital of Soochow University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the rate of differential symdrom | the induction regimen (21 days to 28 days) | DS, known as retinoic acid syndrome, is a severe complication of ATRA or ATO during the differentiation of promyelocytes. Signs of DS are presented as fever, weight gain, hypertension, dyspnoea, radiographic opacities, peripheral edema and acute renal failure. |
Countries
China
Outcome results
None listed