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NCT07597941
Lisaftoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients
Conditions: Acute Promyelocytic Leukemia (APL)
Sex: All
Ages: 16 Years – N/A
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 20
Sponsor: The Affiliated People's Hospital of Ningbo University
Summary
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
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.
Source: ClinicalTrials.gov (NCT07597941). StuddyBuddy aggregates publicly available trial information.