Lisaftoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients

Phase 3Not Yet RecruitingNCT07597941

The Affiliated People's Hospital of Ningbo University20 enrolled

Overview

This study is to assess the efficacy and safety of Lisaftoclax for prevention of DS in APL patients undergoing ATRA/ATO induction regimen.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Acute Promyelocytic Leukemia (APL)

Interventions

Lisaftoclax (APG-2575)DRUG

Description: Newly diagnosed APL patients receive standard induction therapy with oral ATRA 25 mg/m²/day and intravenous ATO 0.16 mg/kg/day. Lisaftoclax (APG-2575) is given for DS prophylaxis in patients with peripheral WBC count \>2.0×10⁹/L or ≥24-hour 2-fold WBC elevation. Lisaftoclax can only be initiated 24 hours after ATRA/ATO induction initiation. Dosing and Escalation: Lisaftoclax starts at 50 mg QD. Dose may be escalated to 100 mg QD, with a maximum dose of 100 mg twice daily (bid) based on patient tolerability. Monitoring and Interruption: Daily peripheral blood count monitoring is required during Lisaftoclax treatment. Lisaftoclax must be immediately withheld if the WBC count declines for two consecutive days. Protocol-defined dexamethasone or ruxolitinib will be administered for suspected DS during induction therapy.

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

the rate of Differentiation Syndrom

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.

Time frame: the induction regimen (21 days to 28 days)

Central Contacts

Jiaojiao Yuan

CONTACT

86+15257498577 1142510531@qq.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.