Acute Myeloid Leukemia (AML)Phase 2NCT07505160
Efficacy and Safety of Lisafotoclax Plus Decitabine and Homoharringtonine in Venetoclax/Azacitidine Pretreated AML Patients
A Phase 2 study testing Lisafotoclax, Decitabine and Homoharringtonine in people with Acute Myeloid Leukemia (AML), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- What is being tested?
- Lisafotoclax, Decitabine and Homoharringtonine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- Mar 2026to Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 25Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Wenbin Qian, +86-0571-87783777, qianwb@zju.edu.cn
About this study
Official title: 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.
Read more
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).
- Conditions
- Acute Myeloid Leukemia (AML)
- Being tested
- Lisafotoclax, Decitabine, Homoharringtonine
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LisafotoclaxDrug
Oral investigational BCL-2 inhibitor, administered in two phases:
- LDH induction/consolidation phase (28-day cycles):
- Cycle 1: 200 mg on day 1, 400 mg on day 2, 600 mg on days 3-28;
- Cycle 2 and beyond: 600 mg once daily on days 1-28.
- LD maintenance phase (28-day cycles): 600 mg once daily on days 1-14.
DecitabineDrug
Intravenous hypomethylating agent, administered at 15 mg/m²/day via intravenous infusion over 3 hours on days 1-3 of each 28-day cycle, used in both LDH induction/consolidation and LD maintenance regimens.
HomoharringtonineDrug
Intraversible alkaloid anti-leukemia agent, administered at 1 mg/m²/day via intravenous infusion over 2 hours on days 1-7 of each 28-day cycle, used exclusively in the LDH induction/consolidation phase of the study.
| Study group | Role | What they receive |
|---|---|---|
| Lisafotoclax + Decitabine + Homoharringtonine (LDH) Treatment Arm | Experimental | All participants receive LDH regimen (induction/consolidation) followed by LD regimen maintenance per study protocol, with or without allogeneic hematopoietic stem cell transplantation based on MRD status and fitness. Receives: Drug: Lisafotoclax; Drug: Decitabine; Drug: Homoharringtonine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Complete Response Rate (CRc)
The proportion of participants who achieve composite complete remission (CRc), defined as the combination of complete remission (CR), complete remission with incomplete hematologic recovery (CRi), and morphologic leukemia-free state (MLFS) after 1-2 cycles of LDH induction/consolidation therapy.
Measured: Up to 2 cycles of LDH induction/consolidation therapy (approximately 56 days)
Secondary outcomes (6)
Event-Free Survival (EFS)
The time from the first dose of study treatment to the first occurrence of disease progression, relapse, or death from any cause.
Measured: Up to 12 months after the last patient is enrolled
Complete Response Rate (CR)
The proportion of participants who achieve complete remission (CR), defined as <5% bone marrow blasts, no evidence of extramedullary disease, and recovery of peripheral blood counts (ANC ≥1.0×10⁹/L, platelets ≥100×10⁹/L) after 1-2 cycles of LDH therapy.
Measured: Up to 2 cycles of LDH therapy (approximately 56 days)
Overall Response Rate (ORR)
The proportion of participants who achieve any response (CR + CRi + MLFS + partial remission [PR]) after 1-2 cycles of LDH induction/consolidation therapy.
Measured: Up to 2 cycles of LDH therapy (approximately 56 days)
Time to Response (TTR)
The time from the first dose of study treatment to the first documentation of any response (CR, CRi, MLFS, or PR).
Measured: Up to 2 cycles of LDH therapy (approximately 56 days)
Duration of Response (DOR)
The time from the first documentation of response (CR, CRi, MLFS, or PR) to the first occurrence of disease progression, relapse, or death from any cause.
Measured: Up to 12 months after the last patient is enrolled
Overall Survival (OS)
The time from the first dose of study treatment to death from any cause.
Measured: Up to 12 months after the last patient is enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505160
- Sponsor's protocol ID
- 2026-0140
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07505160
- Acronym / sponsor ID
- 2026-0140
- Conditions
- Acute Myeloid Leukemia (AML)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lisafotoclax + Decitabine + Homoharringtonine (LDH) Treatment Arm | Experimental | Drug: Lisafotoclax, Drug: Decitabine, Drug: HomoharringtonineAll participants receive LDH regimen (induction/consolidation) followed by LD regimen maintenance per study protocol, with or without allogeneic hematopoietic stem cell transplantation based on MRD status and fitness. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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:
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LisafotoclaxOral investigational BCL-2 inhibitor, administered in two phases: 1. LDH induction/consolidation phase (28-day cycles): * Cycle 1: 200 mg on day 1, 400 mg on day 2, 600 mg on days 3-28; * Cycle 2 and beyond: 600 mg once daily on days 1-28. 2. LD maintenance phase (28-day cycles): 600 mg once daily on days 1-14. | Drug | Lisafotoclax + Decitabine + Homoharringtonine (LDH) Treatment Arm |
| DecitabineIntravenous hypomethylating agent, administered at 15 mg/m²/day via intravenous infusion over 3 hours on days 1-3 of each 28-day cycle, used in both LDH induction/consolidation and LD maintenance regimens. | Drug | Lisafotoclax + Decitabine + Homoharringtonine (LDH) Treatment Arm |
| HomoharringtonineIntraversible alkaloid anti-leukemia agent, administered at 1 mg/m²/day via intravenous infusion over 2 hours on days 1-7 of each 28-day cycle, used exclusively in the LDH induction/consolidation phase of the study. | Drug | Lisafotoclax + Decitabine + Homoharringtonine (LDH) Treatment Arm |
Primary outcome
Composite Complete Response Rate (CRc)
Time frame: Up to 2 cycles of LDH induction/consolidation therapy (approximately 56 days)
The proportion of participants who achieve composite complete remission (CRc), defined as the combination of complete remission (CR), complete remission with incomplete hematologic recovery (CRi), and morphologic leukemia-free state (MLFS) after 1-2 cycles of LDH induction/consolidation therapy.
6 secondary outcomes
Event-Free Survival (EFS)
Time frame: Up to 12 months after the last patient is enrolled
Complete Response Rate (CR)
Time frame: Up to 2 cycles of LDH therapy (approximately 56 days)
Overall Response Rate (ORR)
Time frame: Up to 2 cycles of LDH therapy (approximately 56 days)
Time to Response (TTR)
Time frame: Up to 2 cycles of LDH therapy (approximately 56 days)
Duration of Response (DOR)
Time frame: Up to 12 months after the last patient is enrolled
Overall Survival (OS)
Time frame: Up to 12 months after the last patient is enrolled
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lisafotoclax, Decitabine and Homoharringtonine in people with Acute Myeloid Leukemia (AML), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenbin Qian (+86-0571-87783777, qianwb@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Complete Response Rate (CRc) (time frame: Up to 2 cycles of LDH induction/consolidation therapy (approximately 56 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.