Enrolling by invitation NCT06544109
Venetoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: venetoclax.
- Who it may be relevant to
- Registry conditions: Acute Promyelocytic Leukemia. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Venetoclax for Prevention of Differentiation Syndrom (DS) in Acute Promyelocytic Leukemia (APL) Patients : An Open-lable, Single-arm, Multicenter, Phase Ⅱ Clinical Trail
Overview
This study is to assess the efficacy and safety of venetoclax for prevention of DS in APL patients undergoing ATRA/ATO induction regimen.
Interventions
- Drug venetoclax
patients in whom the WBC counts increased to more than 2 × 109/L received Venetoclax
Primary outcome measures
- the rate of differential symdrom [Time frame: the induction regimen (21 days to 28 days)]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 1 center
- Qiu huiying — Suzhou
Identifiers
NCT: NCT06544109 · SZQ002