NCT07813390Enrolling by invitationPhase 2
Homoharringtonine, Lisaftoclax, and Azacitidine for AML After Venetoclax-Based Therapy Failure
A Multi-Center, Prospective, Open-Label, Single-Arm Study of Homoharringtonine Combined With Lisaftoclax and Azacitidine in Patients With Acute Myeloid Leukemia After Failure of Venetoclax-Based Therapy
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
Venetoclax (Ven) resistance is common in the treatment of acute myeloid leukemia (AML). Patients with Ven resistance have poor response and survival, except those with specific targeted therapy. Whether we could use new BCL-2 inhibitors to replace Ven and combine with the agents which have been shown to enhance the antilekeumia effect of BCL-2 inhibitors, to overcome Ven resistance? This is unknown up until now. This multi-center, prospective, open-label, single-arm study will evaluate the efficacy and safety of homoharringtonine combined with lisaftoclax and azacitidine (HLA) as salvage therapy for adults with AML after failure of a Ven-containing regimen. Ven treatment failure is defined as no response after at least two consecutive cycles of a Ven-containing regimen or relapse during continued, protocol-compliant Ven-based therapy after a prior response. The study plans to enroll 73 participants. The primary endpoint is the overall response rate after two treatment cycles. Secondary endpoints include complete remission (CR), CR with incomplete blood count recovery (CRi), measurable residual disease (MRD) negativity, survival and relapse, and treatment-related adverse events.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 73 (estimated)
- First submitted
- 4 Sept 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- Guangdong Second Provincial General Hospital
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07813390
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 73
- From 1 Sept 2026 to the primary completion date, 1 Sept 2027
- 1 site in 1 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
- Acute myeloid leukemia with FLT3, IDH1/2, or NPM1 mutations or MLL rearrangement for which could be treated with a corresponding targeted inhibitor.
- Other clinically significant uncontrolled conditions, including but not limited to an uncontrolled or active systemic viral, bacterial, or fungal infection; chronic hepatitis B virus or hepatitis C virus infection requiring treatment; or a concurrent second malignancy requiring active treatment.
Other illness
- Known hypersensitivity to any study drug.
- Active human immunodeficiency virus infection.
- Any condition that, in the investigator's opinion, makes the patient unsuitable for enrollment.
Other
- Acute promyelocytic leukemia.
- Acute myeloid leukemia with central nervous system involvement.
- Pregnant or breastfeeding.
Who the study is looking for
- Diagnosis of acute myeloid leukemia according to the World Health Organization classification.
- Age 18 years or older.
- Failure after venetoclax exposure, defined as either no response after at least 2 consecutive cycles of a venetoclax-containing regimen or disease relapse during continued, protocol-compliant treatment with a venetoclax-containing regimen after a prior response.
- Creatinine clearance of at least 30 mL/min.
- Alanine aminotransferase less than 5 times the upper limit of normal and bilirubin less than 3 times the upper limit of normal.
- Life expectancy of at least 3 months.
- Able to receive oral lisaftoclax.
- Able to understand and comply with protocol procedures and willing to provide written informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guangdong Second Provincial General Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.