A Phase 2/3 interventional study of Lisaftoclax (APG-2575) in Acute Promyelocytic Leukemia (APL), sponsored by The Affiliated People's Hospital of Ningbo University. Not yet recruiting. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by The Affiliated People's Hospital of Ningbo University · Phase 2/3, Interventional, and Prevention
This study is to assess the efficacy and safety of Lisaftoclax for prevention of DS in APL patients undergoing ATRA/ATO induction regimen.
Exclusion Criteria:
Drug: Lisaftoclax (APG-2575)
Description: Newly diagnosed APL patients receive standard induction therapy with oral ATRA 25 mg/m²/day and intravenous ATO 0.16 mg/kg/day. Lisaftoclax (APG-2575) is given for DS prophylaxis in patients with peripheral WBC count \>2.0×10⁹/L or ≥24-hour 2-fold WBC elevation. Lisaftoclax can only be initiated 24 hours after ATRA/ATO induction initiation. Dosing and Escalation: Lisaftoclax starts at 50 mg QD. Dose may be escalated to 100 mg QD, with a maximum dose of 100 mg twice daily (bid) based on patient tolerability. Monitoring and Interruption: Daily peripheral blood count monitoring is required during Lisaftoclax treatment. Lisaftoclax must be immediately withheld if the WBC count declines for two consecutive days. Protocol-defined dexamethasone or ruxolitinib will be administered for suspected DS during induction therapy.
the rate of Differentiation Syndrom
DS, known as retinoic acid syndrome, is a severe complication of ATRA or ATO during the differentiation of promyelocytes. Signs of DS are presented as fever, weight gain, hypertension, dyspnoea, radiographic opacities, peripheral edema and acute renal failure.
Time frame: the induction regimen (21 days to 28 days)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Leukemia, Promyelocytic, Acute→
The Affiliated People's Hospital of Ningbo University