HVA in the Treatment of Mixed-Phenotype Acute Leukemia(MPAL). (HVA-MPAL)

April 1, 2026 updated by: Qing Zhang, Guangdong Second Provincial General Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Department of Hematology, Guangdong Second Provincial General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The patient fully understands this study, voluntarily participates, and signs the informed consent form (ICF);
  2. Age ≥18 years;
  3. Newly diagnosed with MPAL according to the World Health Organization (WHO) 2022 classification.
  4. 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);
  5. Expected survival ≥12 weeks;
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
  7. 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;

Exclusion Criteria:

  1. Patients who have had or currently have other malignant tumors requiring treatment;
  2. Patients with central nervous system (CNS) infiltration;
  3. 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.;
  4. Patients who cannot take oral medications or have malabsorption syndrome;
  5. Patients with a known history of immediate or delayed hypersensitivity reactions to drugs of the same class as the study medication or to excipients;
  6. Pregnant or breastfeeding women, or patients who refuse to use effective contraception during the study;
  7. Patients with a history of severe neurological or psychiatric disorders who cannot understand or comply with the study protocol;
  8. Patients with severe heart disease, such as myocardial infarction, severe or unstable angina, severe arrhythmias;
  9. 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;
  10. Patients who cannot take oral medications or have malabsorption syndrome;
  11. Patients whom the investigator determines are unsuitable to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HVA regiment
HVA regiment for newly diagnosed MPAL
Drug: HVA
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
At the end of cycle 2 (28 days for a cycle)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete remission (CR)
Time Frame: At the end of cycle 2 (28 days for a cycle)
Camplete remission is defined as BM with>5% blasts and wthout extramedullary infltration and recovery of peripheral blood cells.
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)
ORR includes CRc, partial response (PR), and morphologic leukemia-free state(MLFS).
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)
MRD is monitored using flow cytometric analysis with a positive MRD threshold of 0.1%.
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)
Adverse events including hematologic and nonhematologic toxicities in the treatment of HVA regimen
At the end of cycle 2 (28 days for a cycle)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 1 year
OS is calculated from enrollment to death or the last follow-up.
1 year
Relapse-Free Survival (RFS)
Time Frame: 1 year
The time from the beginning of the implementation of the mitigation measures to the occurrence of disease progression, any cause of death, or the last follow-up visit
1 year
Duration of Response (DOR)
Time Frame: 1 years
It refers to the period from when the patient achieves CR/CRi until the patient loses CR/CRi.
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangdong Second Provincial General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Guangzhou First People's Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Shenzhen Second People's Hospital
Dongguan People's Hospital
Zhongshan People's Hospital, Guangdong, China
First Affiliated Hospital of Guangxi Medical University
Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GD2H-2026-571

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings