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Not yet recruiting NCT07597941

Lisaftoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients

Phase II / Phase III Interventional Acute Promyelocytic Leukemia (APL)

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: Lisaftoclax (APG-2575).
Who it may be relevant to
Registry conditions: Acute Promyelocytic Leukemia (APL). Basic parameters: from 16 years · 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
Center list to be confirmed — check the primary protocol.
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

Lisaftoclax 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 Lisaftoclax for prevention of DS in APL patients undergoing ATRA/ATO induction regimen.

Interventions

  • Drug Lisaftoclax (APG-2575)
    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) base

Primary outcome measures

  • the rate of Differentiation Syndrom [Time frame: the induction regimen (21 days to 28 days)]

Eligibility criteria

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.

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

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07597941 · 2026-APG-2575

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗