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Lisaftoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients

NCT07597941 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-20

No results posted yet for this study

Summary

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

Conditions

  • Acute Promyelocytic Leukemia (APL)

Interventions

DRUG

Lisaftoclax (APG-2575)

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 & Collaborators

  • The Affiliated People's Hospital of Ningbo University

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-06-30
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07597941 on ClinicalTrials.gov