Acute Promyelocytic Leukemia (APL)
Conditions
Keywords
Acute Promyelocytic Leukemia, Lisaftoclax, Differentiation Syndrom
Brief summary
This study is to assess the efficacy and safety of Lisaftoclax for prevention of DS in APL patients undergoing ATRA/ATO induction regimen.
Interventions
After the diagnosis of acute promyelocytic leukemia (APL), patients receive initial treatment with all-trans retinoic acid (ATRA) 25 mg/m²/day and arsenic trioxide (ATO) 0.16 mg/kg/day. During the induction phase, lisaftoclax (APG-2575) is administered orally once daily with a dose-escalation schedule for differentiation syndrome prophylaxis: Day 1: 20 mg; Day 2: 50 mg; Day 3: 100 mg; Day 4: 200 mg; Day 5: 400 mg; starting on Day 6: 600 mg once daily, maintained through Day 28. Patients with suspected differentiation syndrome receive dexamethasone or ruxolitinib as per the study protocol.
Sponsors
The Affiliated People's Hospital of Ningbo University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Patients aged ≥ 16 years old. * 2\. Confirmed diagnosis of acute promyelocytic leukemia (APL) by morphology, flow cytometry, and cytogenetics/molecular testing. * 3\. ECOG performance status 0-2. * 4\. Adequate organ function: * Serum creatinine ≤ 1.5 × ULN * Total bilirubin ≤ 2 × ULN * AST/ALT ≤ 3 × ULN * 5\. Able to understand and sign the informed consent form.
Exclusion criteria
* 1\. Concurrent participation in another interventional clinical trial. * 2\. History of other malignancies within the past 5 years (except cured basal cell carcinoma or in situ cervical cancer). * 3\. Severe uncontrolled infection or other serious underlying diseases that may interfere with study treatment or follow-up. * 4\. Known hypersensitivity to lisaftoclax, ATRA, ATO, or any components of the study regimen. * 5\. Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the rate of Differentiation Syndrom | 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. |
Contacts
CONTACTJiaojiao Yuan
Outcome results
None listed