Lisaftoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Acute Promyelocytic Leukemia (APL) Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Promyelocytic, Acute Neoplasms Neoplasms by Histologic Type

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

the rate of Differentiation Syndrom

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiaojiao Yuan

CONTACT

[email protected]

86+15257498577

Sponsors and collaborators

Lead sponsor

The Affiliated People's Hospital of Ningbo University

Other Gov

Registry information

Official study title

Lisaftoclax for Prevention of Differentiation Syndrom (DS) in Acute Promyelocytic Leukemia (APL) Patients : An Open-lable, Single-arm, Multicenter, Phase Ⅱ Clinical Trail

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: May 20, 2026
Registry last updated: Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting