Lisaftoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients (NCT07597941) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Lisaftoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients
60 participantsStarted 2026-07
Plain-language summary
This study is to assess the efficacy and safety of Lisaftoclax for prevention of DS in APL patients undergoing ATRA/ATO induction regimen.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the rate of Differentiation Syndrom
Timeframe: the induction regimen (21 days to 28 days)
Trial details
NCT IDNCT07597941
SponsorThe Affiliated People's Hospital of Ningbo University