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: 60
• 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

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.

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 (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share