Lisaftoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients

NCT07597941 | Not Yet Recruiting Phase 2

• 1 other identifier: 2026-APG-2575
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Promyelocytic Leukemia (APL)

Keywords

Acute Promyelocytic Leukemia; Lisaftoclax; Differentiation Syndrom

Outcome Measures

Primary Outcomes (1)

• 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.

  the induction regimen (21 days to 28 days)

Study Arms (1)

Lisaftoclax for Prevention of Differentiation Syndrom

EXPERIMENTAL

Drug: Lisaftoclax (APG-2575)

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.

Lisaftoclax for Prevention of Differentiation Syndrom

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients aged ≥ 16 years old.
• \. Confirmed diagnosis of acute promyelocytic leukemia (APL) by morphology, flow cytometry, and cytogenetics/molecular testing.
• \. ECOG performance status 0-2.
• \. Adequate organ function:
• Serum creatinine ≤ 1.5 × ULN
• Total bilirubin ≤ 2 × ULN
• AST/ALT ≤ 3 × ULN
• \. Able to understand and sign the informed consent form.

You may not qualify if:

• \. Concurrent participation in another interventional clinical trial.
• \. History of other malignancies within the past 5 years (except cured basal cell carcinoma or in situ cervical cancer).
• \. Severe uncontrolled infection or other serious underlying diseases that may interfere with study treatment or follow-up.
• \. Known hypersensitivity to lisaftoclax, ATRA, ATO, or any components of the study regimen.
• \. Pregnant or breastfeeding women.

Sponsors & Collaborators

• The Affiliated People's Hospital of Ningbo University: lead

MeSH Terms

Conditions

Leukemia, Promyelocytic, Acute

Interventions

Lisaftoclax

Condition Hierarchy (Ancestors)

Leukemia, Myeloid, Acute; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Jiaojiao Yuan

CONTACT

86+15257498577; 1142510531@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share