Lisafotoclax with two drugs for acute myeloid leukemia after venetoclax plus azacitidine
Tests lisafotoclax with decitabine and homoharringtonine in adults with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Lisafotoclax Plus Decitabine and Homoharringtonine in Venetoclax/Azacitidine Pretreated AML Patients
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with acute myeloid leukemia (AML) whose earlier treatment with venetoclax plus azacitidine failed or caused too many side effects.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Acute myeloid leukemia, not acute promyelocytic leukemia (APL). Earlier venetoclax + azacitidine did not work or was not tolerated. Examples: no partial remission after 1-2 cycles, driver gene mutations getting worse, or 5% or more blasts in the bone marrow after a remission. Daily activity level (ECOG) 0-2.
- Earlier treatment
- Must have had venetoclax + azacitidine, with treatment failure or intolerance. Cannot have had any other BCL-2 inhibitor.
Main reasons for not taking part
- Acute promyelocytic leukemia (APL) or Philadelphia chromosome-positive AML
- Leukemia in the central nervous system
- Known HIV infection, or active hepatitis B or C
- Uncontrolled infection or other uncontrolled cancer
- Pregnant or breastfeeding
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07505160, who can take part
Where in China
- The Second Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Trial code
- NCT07505160
- Record updated
- 1 April 2026
- Original description
This is a multi-center, prospective, single-arm, phase 2 clinical study conducted in China to evaluate the efficacy and safety of Lisafotoclax combined with Decitabine and Homoharringtonine in patients with acute myeloid leukemia (AML) who have failed or are intolerant to prior treatment with Venetoclax plus Azacitidine.Read full original descriptionShow less
A Multi-Center, Prospective, Single-Arm, Phase 2 Clinical Study on the Efficacy and Safety of Lisafotoclax Combined With Decitabine and Homoharringtonine in Patients With Acute Myeloid Leukemia Previously Treated With Venetoclax Combined With Azacitidine Regimen
This is a multi-center, prospective, single-arm, phase 2 clinical study conducted in China to evaluate the efficacy and safety of Lisafotoclax combined with Decitabine and Homoharringtonine in patients with acute myeloid leukemia (AML) who have failed or are intolerant to prior treatment with Venetoclax plus Azacitidine.
Eligible participants must be at least 18 years old, have a confirmed diagnosis of AML according to WHO 2016 criteria, and have an ECOG performance status of 0-2. Participants will receive oral Lisafotoclax in combination with intravenous Decitabine and Homoharringtonine according to the study protocol.
The primary objective is to assess the overall response rate (ORR) after induction treatment. Secondary objectives include evaluating complete remission (CR) rate, event-free survival (EFS), overall survival (OS), and the incidence of adverse events (AEs) and serious adverse events (SAEs). Participants will be followed for up to 12 months after the last patient is enrolled to collect long-term efficacy and safety data.
This study has been approved by the Ethics Committee of the Second Affiliated Hospital of Zhejiang University School of Medicine and will be conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice (GCP).
Inclusion: Age ≥18 years old; Diagnosis of acute myeloid leukemia (AML), not otherwise specified (non-acute promyelocytic leukemia [APL]), confirmed by WHO 2022 5th edition criteria; Evidence of treatment failure after prior venetoclax + azacitidine (VA) regimen, defined as either:; VA intolerance: Treatment discontinuation due to ≥Grade 3 non-hematologic toxicity or persistent ≥Grade 4 hematologic toxicity; VA treatment failure:; Primary resistance: No partial remission (PR) after 1-2 cycles of VA induction therapy; Molecular persistence/progression: ≥1 log increase or persistent positivity of driver gene mutations (e.g., FLT3-ITD, IDH1/2, NPM1) by quantitative PCR or NGS compared to best response; Hematologic relapse: ≥5% bone marrow blasts or extramedullary leukemia after prior CR/CRi; Eastern Cooperative Oncology Group (ECOG) performance status 0-2; Adequate organ function within 7 days prior to study initiation:; Liver: Total bilirubin ≤1.5×ULN; AST/ALT ≤2.5×ULN; Kidney: Serum creatinine ≤1.5×ULN or CrCl ≥50 mL/min; Heart: Left ventricular ejection fraction (LVEF) ≥50%; Ability to provide written informed consent and comply with study procedures. Exclusion Criteria; Diagnosis of acute promyelocytic leukemia (APL) or Philadelphia chromosome-positive AML; Prior treatment with any BCL-2 inhibitor other than venetoclax as part of VA regimen; Active central nervous system (CNS) leukemia involvement; Uncontrolled systemic active infection; Known HIV infection, or active hepatitis B or C; New York Heart Association (NYHA) Class III-IV heart failure, unstable angina, myocardial infarction within 6 months, or severe arrhythmia; Other active uncontrolled malignancy; Severe gastrointestinal disease affecting drug absorption; Pregnant or breastfeeding individuals; fertile patients refusing effective contraception during study and 6 months after last dose; Known hypersensitivity to any component of LDH or LD regimens; Any other condition judged by investigator to interfere with study conduct or patient safety.