NCT07597941Not yet recruitingPhase 2/3
Lisaftoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients
Lisaftoclax for Prevention of Differentiation Syndrom (DS) in Acute Promyelocytic Leukemia (APL) Patients : An Open-lable, Single-arm, Multicenter, Phase Ⅱ Clinical Trail
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Brief summary (registry, in English)
This study is to assess the efficacy and safety of Lisaftoclax for prevention of DS in APL patients undergoing ATRA/ATO induction regimen.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 14 May 2026
- Start date
- Jul 2026
- Primary completion date
- Jun 2028
- Lead sponsor
- The Affiliated People's Hospital of Ningbo University
- Diseases
- Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT07597941
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 20
- From Jul 2026 to the primary completion date, Jun 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 1\. Concurrent participation in another interventional clinical trial.
Other illness
- 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.
Other
- 5\. Pregnant or breastfeeding women.
Who the study is looking for
- 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.
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.