Lisaftoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age16+
SponsorThe Affiliated People's Hospital of Ningbo University

About this trial

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

Eligibility criteria

Qualifiers

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.

Serum creatinine ≤ 1.5 × ULN

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Lisaftoclax (APG-2575)

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

This trial has no locations