Acute Myeloid Leukemia (AML)Phase 2HLA-AMLNCT07813390
Homoharringtonine, Lisaftoclax, and Azacitidine for AML After Venetoclax-Based Therapy Failure
A Phase 2 study testing Lisaftoclax (APG-2575), homoharringtonine and Azacitidine (AZA) in people with Acute Myeloid Leukemia (AML), run by Guangdong Second Provincial General Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- What is being tested?
- Lisaftoclax (APG-2575), homoharringtonine and Azacitidine (AZA)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 31 Aug 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Acute promyelocytic leukemia.
- Acute myeloid leukemia with central nervous system involvement.
- 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.
- Known hypersensitivity to any study drug.
- Active human immunodeficiency virus infection.
- Pregnant or breastfeeding.
- Any condition that, in the investigator's opinion, makes the patient unsuitable for enrollment.
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
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, 510317
About this study
Official title: 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
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.
Read the detailed description
Venetoclax-based regimens are widely used in acute myeloid leukemia, but patients who do not respond or who relapse during continued venetoclax therapy have poor outcomes and limited low-intensity treatment options. Lisaftoclax is a selective BCL-2 inhibitor with clinical activity in myeloid malignancies, including preliminary activity in patients previously exposed to venetoclax. Prior preclinical and clinical work by the study group suggests that homoharringtonine may enhance the antileukemic activity of BCL-2 inhibitor-based therapy.
Participants will receive the HLA regimen in 28-day cycles. Homoharringtonine will be administered at 1 mg/m^2 by intravenous infusion on Days 1-7. Lisaftoclax will be administered orally at 200 mg on Day 1, 400 mg on Day 2, and 600 mg on Days 3-14. Azacitidine will be administered at 75 mg/m^2 by subcutaneous injection on Days 1-7. When concomitant use of a strong CYP3A4 inhibitor is required, the lisaftoclax dose will be reduced to 200-400 mg/day.
Response will be assessed using blood counts, bone marrow morphology, and measurable residual disease testing. Bone marrow assessment is planned around Day 14 or Day 28 of each salvage cycle. Participants who achieve complete remission, complete remission with incomplete hematologic recovery, or a morphologic leukemia-free state may proceed to allogeneic hematopoietic stem cell transplantation when feasible or receive further protocol-directed therapy. Participants with partial response or no response after the first cycle may receive a second HLA cycle. Participants with no response after reassessment following the second cycle will discontinue study treatment.
The study will evaluate overall response after two cycles, additional remission outcomes, measurable residual disease negativity, overall survival, relapse-free survival, duration of response, relapse, and safety. Exploratory whole-genome sequencing, RNA sequencing, targeted next-generation sequencing, and single-cell sequencing will be used to characterize biological correlates of response and investigate mechanisms of venetoclax resistance and response to the HLA regimen.
- Conditions
- Acute Myeloid Leukemia (AML)
- Being tested
- Lisaftoclax (APG-2575), homoharringtonine, Azacitidine (AZA)
- Keywords
- Venetoclax treatment failure, Venetoclax resistance, Salvage therapy, Lisaftoclax, Homoharringtonine, Azacitidine, BCL-2 inhibitor, Measurable residual disease
- Medical subject headings
- Leukemia, Myeloid, Acute, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lisaftoclax (APG-2575)Drug
Lisaftoclax will be administered orally on Days 1-14 of each 28-day cycle: 200 mg on Day 1, 400 mg on Day 2, and 600 mg once daily on Days 3-14. If concomitant use of a CYP3A4 inhibitor is required, the protocol specifies a reduced lisaftoclax dose of 200-400 mg/day according to the instruction.
homoharringtonineDrug
Homoharringtonine will be administered at 1 mg/m^2 by intravenous infusion once daily on Days 1-7 of each 28-day cycle.
Azacitidine (AZA)Drug
Azacitidine will be administered at 75 mg/m^2 by subcutaneous injection once daily on Days 1-7 of each 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| HLA Regimen | Experimental | Participants will receive homoharringtonine, lisaftoclax, and azacitidine in 28-day salvage-treatment cycles. One or two cycles will be administered according to treatment response and eligibility for allogeneic hematopoietic stem cell transplantation, as described in the protocol. Receives: Drug: Lisaftoclax (APG-2575); Drug: homoharringtonine; Drug: Azacitidine (AZA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate After Two Cycles of HLA Therapy
The proportion of participants who achieve complete remission (CR), complete remission with incomplete hematologic recovery (CRi), partial remission (PR), or morphologic leukemia-free state (MLFS). CR is defined as bone marrow blasts <5%, no peripheral blood blasts or extramedullary disease, neutrophils >=1 x 10^9/L, and platelets >=100 x 10^9/L. CRi is defined as meeting the CR criteria except for neutrophils <1 x 10^9/L and/or platelets <100 x 10^9/L. PR is defined as a >60% reduction in bone marrow blasts with bone marrow blasts <20%. MLFS is defined as bone marrow blasts <5%, no peripheral blood blasts or extramedullary disease, without a requirement for blood-count recovery.
Measured: At the end of Cycle 2 (each cycle is 28 days; approximately Day 56)
Secondary outcomes (8)
Composite Complete Remission Rate
The proportion of participants who achieve complete remission or complete remission with incomplete hematologic recovery according to the protocol-defined response criteria.
Measured: At the end of Cycle 2 (approximately Day 56)
Complete Remission Rate
The proportion of participants who achieve complete remission according to the protocol-defined response criteria.
Measured: At the end of Cycle 2 (approximately Day 56)
Measurable Residual Disease Negativity Rate
The proportion of responding participants who have a measurable residual disease-negative result according to the standard MRD criteria adopted by the study center with flow cytometry.
Measured: At response assessment after Cycle 2 (up to approximately Day 56)
Overall Survival
Time from initiation of study treatment to death from any cause. Participants who are alive at the analysis cutoff will be censored on the last date they are known to be alive.
Measured: From initiation of study treatment through study completion (planned follow-up of at least 12 months)
Relapse-Free Survival
Time from the first documented remission to disease relapse or progression, death from any cause, or the last disease assessment. Participants without an event will be censored at the last disease assessment.
Measured: From the first documented remission through study completion (planned follow-up of at least 12 months)
Duration of Response
Time from the first documented complete remission or complete remission with incomplete hematologic recovery to loss of that response. Participants without loss of response will be censored at the last valid response assessment.
Measured: From the first documented CR or CRi through study completion (planned follow-up of at least 12 months)
Cumulative Incidence of Relapse
The cumulative incidence of relapse after remission, with death before relapse treated as a competing event.
Measured: From the first documented remission through study completion (planned follow-up of at least 12 months)
Adverse Events
The number and proportion of participants with treatment-related hematologic or nonhematologic adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0
Measured: From the first HLA dose through the protocol-specified 30-day safety follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion31 Aug 2028 (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.
- 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
- Model description
- All enrolled participants from multi-centers will receive the HLA regimen. There is no concurrent control arm.
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Second Provincial General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dongguan Kanghua Hospital, Nanfang Hospital, Southern Medical University, Huizhou First Hospital, First Affiliated Hospital of Shantou University Medical College, Guangzhou First People's Hospital, Jiangmen Central Hospital
- Responsible party
- Principal investigator, Qing Zhang, Guangdong Second Provincial General Hospital
- Investigators
- Guopan Yu, PhD, Principal investigator, Guangdong Second Provincial General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813390
- Sponsor's protocol ID
- HLA-AML-VENFAIL-2026
- Acronym
- HLA-AML
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07813390
- Acronym / sponsor ID
- HLA-AML / HLA-AML-VENFAIL-2026
- Conditions
- Acute Myeloid Leukemia (AML)
- Keywords
- Venetoclax treatment failure, Venetoclax resistance, Salvage therapy, Lisaftoclax, Homoharringtonine, Azacitidine, BCL-2 inhibitor, Measurable residual disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Guangdong Second Provincial General HospitalUniversity, hospital or other
- Collaborators
- Dongguan Kanghua Hospital, Nanfang Hospital, Southern Medical University, Huizhou First Hospital, First Affiliated Hospital of Shantou University Medical College, Guangzhou First People's Hospital, Jiangmen Central Hospital
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 10 Sep 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.
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.
Detailed description
Venetoclax-based regimens are widely used in acute myeloid leukemia, but patients who do not respond or who relapse during continued venetoclax therapy have poor outcomes and limited low-intensity treatment options. Lisaftoclax is a selective BCL-2 inhibitor with clinical activity in myeloid malignancies, including preliminary activity in patients previously exposed to venetoclax. Prior preclinical and clinical work by the study group suggests that homoharringtonine may enhance the antileukemic activity of BCL-2 inhibitor-based therapy.
Participants will receive the HLA regimen in 28-day cycles. Homoharringtonine will be administered at 1 mg/m^2 by intravenous infusion on Days 1-7. Lisaftoclax will be administered orally at 200 mg on Day 1, 400 mg on Day 2, and 600 mg on Days 3-14. Azacitidine will be administered at 75 mg/m^2 by subcutaneous injection on Days 1-7. When concomitant use of a strong CYP3A4 inhibitor is required, the lisaftoclax dose will be reduced to 200-400 mg/day.
Response will be assessed using blood counts, bone marrow morphology, and measurable residual disease testing. Bone marrow assessment is planned around Day 14 or Day 28 of each salvage cycle. Participants who achieve complete remission, complete remission with incomplete hematologic recovery, or a morphologic leukemia-free state may proceed to allogeneic hematopoietic stem cell transplantation when feasible or receive further protocol-directed therapy. Participants with partial response or no response after the first cycle may receive a second HLA cycle. Participants with no response after reassessment following the second cycle will discontinue study treatment.
The study will evaluate overall response after two cycles, additional remission outcomes, measurable residual disease negativity, overall survival, relapse-free survival, duration of response, relapse, and safety. Exploratory whole-genome sequencing, RNA sequencing, targeted next-generation sequencing, and single-cell sequencing will be used to characterize biological correlates of response and investigate mechanisms of venetoclax resistance and response to the HLA regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants from multi-centers will receive the HLA regimen. There is no concurrent control arm.
| Arm | Type | Receives |
|---|---|---|
| HLA Regimen | Experimental | Drug: Lisaftoclax (APG-2575), Drug: homoharringtonine, Drug: Azacitidine (AZA)Participants will receive homoharringtonine, lisaftoclax, and azacitidine in 28-day salvage-treatment cycles. One or two cycles will be administered according to treatment response and eligibility for allogeneic hematopoietic stem cell transplantation, as described in the protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- Acute promyelocytic leukemia.
- Acute myeloid leukemia with central nervous system involvement.
- 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.
- Known hypersensitivity to any study drug.
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 |
|---|---|---|
| Lisaftoclax (APG-2575)Lisaftoclax will be administered orally on Days 1-14 of each 28-day cycle: 200 mg on Day 1, 400 mg on Day 2, and 600 mg once daily on Days 3-14. If concomitant use of a CYP3A4 inhibitor is required, the protocol specifies a reduced lisaftoclax dose of 200-400 mg/day according to the instruction. | Drug | HLA Regimen |
| homoharringtonineHomoharringtonine will be administered at 1 mg/m^2 by intravenous infusion once daily on Days 1-7 of each 28-day cycle. | Drug | HLA Regimen |
| Azacitidine (AZA)Azacitidine will be administered at 75 mg/m^2 by subcutaneous injection once daily on Days 1-7 of each 28-day cycle. | Drug | HLA Regimen |
Primary outcome
Overall Response Rate After Two Cycles of HLA Therapy
Time frame: At the end of Cycle 2 (each cycle is 28 days; approximately Day 56)
The proportion of participants who achieve complete remission (CR), complete remission with incomplete hematologic recovery (CRi), partial remission (PR), or morphologic leukemia-free state (MLFS). CR is defined as bone marrow blasts <5%, no peripheral blood blasts or extramedullary disease, neutrophils >=1 x 10^9/L, and platelets >=100 x 10^9/L. CRi is defined as meeting the CR criteria except for neutrophils <1 x 10^9/L and/or platelets <100 x 10^9/L. PR is defined as a >60% reduction in bone marrow blasts with bone marrow blasts <20%. MLFS is defined as bone marrow blasts <5%, no peripheral blood blasts or extramedullary disease, without a requirement for blood-count recovery.
8 secondary outcomes
Composite Complete Remission Rate
Time frame: At the end of Cycle 2 (approximately Day 56)
Complete Remission Rate
Time frame: At the end of Cycle 2 (approximately Day 56)
Measurable Residual Disease Negativity Rate
Time frame: At response assessment after Cycle 2 (up to approximately Day 56)
Overall Survival
Time frame: From initiation of study treatment through study completion (planned follow-up of at least 12 months)
Relapse-Free Survival
Time frame: From the first documented remission through study completion (planned follow-up of at least 12 months)
Duration of Response
Time frame: From the first documented CR or CRi through study completion (planned follow-up of at least 12 months)
Cumulative Incidence of Relapse
Time frame: From the first documented remission through study completion (planned follow-up of at least 12 months)
Adverse Events
Time frame: From the first HLA dose through the protocol-specified 30-day safety follow-up
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 10 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Guopan Yu, PhD principal investigator
Guangdong Second Provincial General Hospital
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 Lisaftoclax (APG-2575), homoharringtonine and Azacitidine (AZA) in people with Acute Myeloid Leukemia (AML), run by Guangdong Second Provincial General Hospital 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 8 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 10 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate After Two Cycles of HLA Therapy (time frame: At the end of Cycle 2 (each cycle is 28 days; approximately Day 56)). 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 10 Sep 2026.