Newly Diagnosed Mixed Phenotype Acute Leukemia (MPAL)Phase 2HVA-MPALNCT07517510
HVA in the Treatment of Mixed-Phenotype Acute Leukemia(MPAL).
A Phase 2 study testing HVA in people with Newly Diagnosed Mixed Phenotype Acute Leukemia (MPAL), run by Guangdong Second Provincial General Hospital at 1 site in China.
Trial summary
This study aims to evaluate the safety and efficacy of homoharringtonine combined with venetoclax and azacitidine regimen (HVA) in newly diagnosed MPAL patients, providing a basis for the use of the HVA regimen in the treatment of MPAL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Newly Diagnosed Mixed Phenotype Acute Leukemia (MPAL)
- What is being tested?
- HVA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 31 Dec 2027
- 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
- The patient fully understands this study, voluntarily participates, and signs the informed consent form (ICF);
- Age ≥18 years;
- Newly diagnosed with MPAL according to the World Health Organization (WHO) 2022 classification.
- The patient has not started anti-leukemia treatment after the initial diagnosis (except cytoreductive therapy, such as hydroxyurea or cytarabine <1.0 g/day or glucocorticoids);
- Expected survival ≥12 weeks;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- Normal cardiac function, left ventricular ejection fraction ≥50%; normal renal function: creatinine clearance ≥30 ml/min; normal liver function: ALT <5 times the normal value, bilirubin <3 times the normal value;
Who cannot join
- Patients who have had or currently have other malignant tumors requiring treatment;
- Patients with central nervous system (CNS) infiltration;
- Other clinically significant uncontrolled conditions, including but not limited to: (1) uncontrolled or active systemic infections (viral, bacterial, or fungal); (2) chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) requiring treatment; (3) uncontrolled hypertension, etc.;
- Patients who cannot take oral medications or have malabsorption syndrome;
- Patients with a known history of immediate or delayed hypersensitivity reactions to drugs of the same class as the study medication or to excipients;
- Pregnant or breastfeeding women, or patients who refuse to use effective contraception during the study;
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- Patients with a history of severe neurological or psychiatric disorders who cannot understand or comply with the study protocol;
- Patients with severe heart disease, such as myocardial infarction, severe or unstable angina, severe arrhythmias;
- Patients known to be infected with human immunodeficiency virus (HIV); patients with active hepatitis B or C; subjects who are inactive hepatitis carriers or whose viral hepatitis titers are low after treatment with non-prohibited antiviral drugs are not excluded;
- Patients who cannot take oral medications or have malabsorption syndrome;
- Patients whom the investigator determines are unsuitable to participate in this study.
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
Department of Hematology, Guangdong Second Provincial General Hospital
Guangzhou, Guangdong
About this study
Official title: The Efficacy and Safety of Homoharringtonine Combined With Venetoclax and Azacitidine (HVA) in the Treatment of Mixed-Phenotype Acute Leukemia (MPAL), a Multicenter, Prospective, Single-arm Trial
This study aims to evaluate the safety and efficacy of homoharringtonine combined with venetoclax and azacitidine regimen (HVA) in newly diagnosed MPAL patients, providing a basis for the use of the HVA regimen in the treatment of MPAL.
Read the detailed description
Our preliminary studies show that MPAL not only highly expresses BCL-2, but also highly expresses MCL-1, suggesting the need to explore combining MCL-1 inhibitors on the basis of Ven and HMAs. Our preliminary research confirmed that homoharringtonine (HHT) significantly enhances the anti-leukemia effect of Ven/AZA via inhibition of MCL-1. Originally, we designed the HVA regimen by combining HHT with Ven/AZA for the treatment of AML, and achieved better efficacy and safety. Then we exploratively treated 11 MPAL patients with HVA regimen and acquired promising response and safety. In this study, we conduct a multicenter, prospective, single arm trial to evaluate the efficacy and safety of HVA in the treatment of newly diagnosed MPAL.
- Being tested
- HVA
- Keywords
- Mixed Phenotype Acute Leukemia(MPAL), homoharringtonine, venetoclax
- Medical subject headings
- Leukemia, Biphenotypic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HVADrug
HVA regimen: Venetoclax: 100 mg on day 1, 200 mg on Day 2, 400 mg per day from Day 3 to Day 14; Azacitidine: 75 mg/m2 per day by subcutaneous injection from Day 1 to Day 7; Homoharringtonine : 1mg/m2 per day by intravenous infusion from Day 1 to Day 7. If co-administered with CYP3A inhibitors, the dose of venetoclax was adjusted in accordance with prescribing recommendations. Fms-related receptor tyrosine kinase 3 (FLT3) inhibitors were recommended in patients with FLT3-ITD/TKD mutations. Also tyrosine kinase inhibitors were recommended in patients with BCR/ABL-positive.
| Study group | Role | What they receive |
|---|---|---|
| HVA regiment | Experimental | HVA regiment for newly diagnosed MPAL Receives: Drug: HVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Complete Remission (CRc)
The rate of composite complete remission including complete remission (CR) and CR with incomplete blood count recovery (CRi)
Measured: At the end of cycle 2 (28 days for a cycle)
Secondary outcomes (4)
Complete remission (CR)
Camplete remission is defined as BM with>5% blasts and wthout extramedullary infltration and recovery of peripheral blood cells.
Measured: At the end of cycle 2 (28 days for a cycle)
Overall response rate (ORR)
ORR includes CRc, partial response (PR), and morphologic leukemia-free state(MLFS).
Measured: At the end of cycle 2 (28 days for a cycle)
Rate of Measurable residual disease (MRD) negative
MRD is monitored using flow cytometric analysis with a positive MRD threshold of 0.1%.
Measured: At the end of cycle 2 (28 days for a cycle)
Adverse events
Adverse events including hematologic and nonhematologic toxicities in the treatment of HVA regimen
Measured: At the end of cycle 2 (28 days for a cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Mixed Phenotype Acute Leukemia (MPAL)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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Second Provincial General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, First Affiliated Hospital of Guangxi Medical University, Guangzhou First People's Hospital, Zhongshan People's Hospital, Guangdong, China, Dongguan People's Hospital, Shenzhen Second People's Hospital
- Responsible party
- Principal investigator, Qing Zhang, Guangdong Second Provincial General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517510
- Sponsor's protocol ID
- GD2H-2026-571
- Acronym
- HVA-MPAL
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Homoharringtonine Combined With Venetoclax and Azacitidine (HVA) in the Treatment of Mixed-Phenotype Acute Leukemia (MPAL), a Multicenter, Prospective, Single-arm Trial
- ClinicalTrials.gov ID
- NCT07517510
- Acronym / sponsor ID
- HVA-MPAL / GD2H-2026-571
- Keywords
- Mixed Phenotype Acute Leukemia(MPAL), homoharringtonine, venetoclax
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Guangdong Second Provincial General HospitalUniversity, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, First Affiliated Hospital of Guangxi Medical University, Guangzhou First People's Hospital, Zhongshan People's Hospital, Guangdong, China, Dongguan People's Hospital, Shenzhen Second People's Hospital
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 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 study aims to evaluate the safety and efficacy of homoharringtonine combined with venetoclax and azacitidine regimen (HVA) in newly diagnosed MPAL patients, providing a basis for the use of the HVA regimen in the treatment of MPAL.
Detailed description
Our preliminary studies show that MPAL not only highly expresses BCL-2, but also highly expresses MCL-1, suggesting the need to explore combining MCL-1 inhibitors on the basis of Ven and HMAs. Our preliminary research confirmed that homoharringtonine (HHT) significantly enhances the anti-leukemia effect of Ven/AZA via inhibition of MCL-1. Originally, we designed the HVA regimen by combining HHT with Ven/AZA for the treatment of AML, and achieved better efficacy and safety. Then we exploratively treated 11 MPAL patients with HVA regimen and acquired promising response and safety. In this study, we conduct a multicenter, prospective, single arm trial to evaluate the efficacy and safety of HVA in the treatment of newly diagnosed MPAL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HVA regiment | Experimental | Drug: HVAHVA regiment for newly diagnosed MPAL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient fully understands this study, voluntarily participates, and signs the informed consent form (ICF);
- Age ≥18 years;
- Newly diagnosed with MPAL according to the World Health Organization (WHO) 2022 classification.
- The patient has not started anti-leukemia treatment after the initial diagnosis (except cytoreductive therapy, such as hydroxyurea or cytarabine <1.0 g/day or glucocorticoids);
- Expected survival ≥12 weeks;
Key exclusion criteria (11 listed)
- Patients who have had or currently have other malignant tumors requiring treatment;
- Patients with central nervous system (CNS) infiltration;
- Other clinically significant uncontrolled conditions, including but not limited to: (1) uncontrolled or active systemic infections (viral, bacterial, or fungal); (2) chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) requiring treatment; (3) uncontrolled hypertension, etc.;
- Patients who cannot take oral medications or have malabsorption syndrome;
- Patients with a known history of immediate or delayed hypersensitivity reactions to drugs of the same class as the study medication or to excipients;
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 |
|---|---|---|
| HVAHVA regimen: Venetoclax: 100 mg on day 1, 200 mg on Day 2, 400 mg per day from Day 3 to Day 14; Azacitidine: 75 mg/m2 per day by subcutaneous injection from Day 1 to Day 7; Homoharringtonine : 1mg/m2 per day by intravenous infusion from Day 1 to Day 7. If co-administered with CYP3A inhibitors, the dose of venetoclax was adjusted in accordance with prescribing recommendations. Fms-related receptor tyrosine kinase 3 (FLT3) inhibitors were recommended in patients with FLT3-ITD/TKD mutations. Also tyrosine kinase inhibitors were recommended in patients with BCR/ABL-positive. | Drug | HVA regiment |
Primary outcome
Composite Complete Remission (CRc)
Time frame: At the end of cycle 2 (28 days for a cycle)
The rate of composite complete remission including complete remission (CR) and CR with incomplete blood count recovery (CRi)
4 secondary outcomes
Complete remission (CR)
Time frame: At the end of cycle 2 (28 days for a cycle)
Overall response rate (ORR)
Time frame: At the end of cycle 2 (28 days for a cycle)
Rate of Measurable residual disease (MRD) negative
Time frame: At the end of cycle 2 (28 days for a cycle)
Adverse events
Time frame: At the end of cycle 2 (28 days for a cycle)
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 8 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.
The record lists no contact. Use the official record to reach the sponsor.
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 HVA in people with Newly Diagnosed Mixed Phenotype Acute Leukemia (MPAL), 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 7 inclusion and 11 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 8 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?
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?
Composite Complete Remission (CRc) (time frame: At the end of cycle 2 (28 days for a cycle)). 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 8 Apr 2026.