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Not Yet Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07597941). StuddyBuddy aggregates publicly available trial information.