Newly Diagnosed Acute Myeloid Leukemia With High RiskPhase 3NCT06810791
HVA vs IA/DA or VA in the Treatment of ND HR-AML
A Phase 3 study testing HVA, VA and Standard Chemotherapy in people with Newly Diagnosed Acute Myeloid Leukemia With High Risk, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
The aim of this study is to evaluate the safety and efficacy of homohartonine combined with venetoclax and azacitidine (HVA) versus intensive chemotherapy (IA/DA) or venetoclax combined with azacitidine (VA) in newly diagnosed high-risk AML patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Newly Diagnosed Acute Myeloid Leukemia With High Risk
- What is being tested?
- HVA, VA and Standard Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 876 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2026
- Phase
- Phase 3
- 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
- According to the world health organization (WHO) classification of newly diagnosed with AML patients;
- Age ≥18 years old;
- High-risk patients should meet any of the following criteria: ① High risk group according to the European Leukemia Risk stratification (ELN) 2022; (2) Secondary AML (sAML) which develops from myelodysplastic syndrome (MDS), bone marrow hyperplastic tumor (MPN) or chronic myeloid cell leukemia, et.; (3) Treatment-related AML (t-AML), Patients have a history of cytotoxic treatment record or ionizing radiation therapy.
- Patients did not receive anti-AML therapy (except leukopenia therapy, such as hydroxyurea or cytarabine < 1.0g/d) after the diagnosis of AML;
- Expected survival ≥12 weeks;
- The eastern tumor cooperation group (ECOG) score 3 points or less;
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- Kidney function: creatinine clearance acuity 30 ml/min;
- Liver function: ALT < 5 times normal value, bilirubin < 3 times normal value;
- Sign the informed consent form and understand and abide by the plan calls for process.
Who cannot join
- Acute promyelocytic leukemia;
- With central nervous system leukemia (CNSL) ;
- The cardiac function > level 2;
- The AIDS virus (HIV) infection;
- Other clinical significance of uncontrolled condition, including but not limited to: (1) out of control, or active systemic infection (viruses, bacteria or fungi); (2) chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) requiring treatment; (3) need to actively deal with the merger of the second tumor;
- Can't take oral treatment or having a gastrointestinal disease impact ing the absorption;
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- Being allergy to the experimental drugs;
- Pregnant and lactating women;
- Patients who could not understand or adhere to the study protocol;
- Patients deemed by the investigator to be ineligible 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, 1 recruiting
- Recruiting
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Guopan Yu, +8615876559968, yugpp@163.com
About this study
Official title: The Efficacy and Safety of Homoharringtonine Combined With Venetoclax and Azacitidine Versus Standard Chemotherapy or VA in the Treatment of Acute Myeloid Leukemia With High-risk, a Multicenter, Prospective, Randomized Study
The aim of this study is to evaluate the safety and efficacy of homohartonine combined with venetoclax and azacitidine (HVA) versus intensive chemotherapy (IA/DA) or venetoclax combined with azacitidine (VA) in newly diagnosed high-risk AML patients.
Read the detailed description
The HVA regimen exerts a synergistic pro-apoptotic effect and has demonstrated significant clinical efficacy against R/R AML and also overcomes adaptive resistance observed in the VA regimen. Exploratory work with small sample sizes in first-line settings suggests that combination of HHT and Ven+AZA exhibits potent anti-AML effects with good safety profiles, particularly in overcoming the impact of high-risk factors associated with AML relative to standard treatments. This indicates its potential as a more ideal option for the treatment of newly diagnosed AML with high risk factors. Therefore a prospective, multi-center, randomized controlled clinical study is planned to evaluate the efficacy and safety of the HVA regimen compared to intensive chemotherapy (IA/DA) or Venetoclax plus azacitidine (VA) regimens in newly diagnosed high-risk fit-AML or unfit AML patients.
- Being tested
- HVA, VA, Standard Chemotherapy
- Keywords
- HVA regimen, Intensive chenmotherapy, Fit, randomized controlled trial, Phase 3, VEN combined with AZA, Unfit, Newly diagnosed, High risk, Acute myeloid leukemia
- 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.
HVADrug
Homoharringtonine (HHT) is given by venous drip daily at 1 mg/m2 from day 1 to 7. Venetoclax (VEN) is given 100 mg on day 1, 200 mg on day 2, and 400 mg orally from day 3 to day 14. Azacitidine (AZA) is given 75 mg/m2 subcutaneously from day 1 to 7.
VADrug
VEN is given 100 mg on day 1, 200 mg on day 2, and 400 mg orally from day 3 to day 28, and AZA (75 mg/m2) is given subcutaneously from day 1 to 7.
Standard ChemotherapyDrug
Standard Chemotherapy includes IA(Idarubicin combined with Cytarabine) or DA(Daunorubicin combined with Cytarabine). IDA is given by venous drip daily at 12mg/m2, or DNR is given by venous drip daily at 60mg/m2, from day 1-3, combined with Ara-C at 100mg/m2 by continuously venous drip from day 1-7.
| Study group | Role | What they receive |
|---|---|---|
| IC regiment for Fit-AML | Active comparator | Not described Receives: Drug: Standard Chemotherapy |
| HVA regiment for Fit-AML | Experimental | Not described Receives: Drug: HVA |
| VA regiment for unfit-AML | Active comparator | Not described Receives: Drug: VA |
| HVA regiment for unfit-AML | Experimental | Not described Receives: Drug: HVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite complete remission (CRc)
CRc includes complete remission (CR) and complete remission accompanied with with incomplete count recovery (CRi).
Measured: At the end of cycle 2 (each cycle is 28 days).
Secondary outcomes (7)
Complete remission (CR)
Complete remission is defined as BM with >5% blasts and without extramedullary infltration and recovery of peripheral blood cells.
Measured: At the end of cycle 2 (each cycle is 28 days).
Overall response rate (ORR)
ORR includes CRc, partial response (PR), and morphologic leukemia-free state (MLFS).
Measured: At the end of cycle 2 (each cycle is 28 days).
DOR
duration of response
Measured: 1 year
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 (each cycle is 28 days).
Overall survival (OS)
OS is calculated from enrollment to death or the last follow-up.
Measured: 1 year
Event-free survival (EFS)
EFS is calculated from enrollment to the date of relapse or death or the last follow-up.
Measured: 1 year
Adverse events (AE)
AE are recorded from the first dose until 28 days after treatment discontinuation and are graded according to the NCI Common Terminology Criteria for Adverse Events version 5.0.
Measured: The first dose until 28 days after treatment discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Jan 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Acute Myeloid Leukemia With High RiskStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with newly diagnosed AML with high risk will be divided into two cohorts, including patients being eligible for intensive chemotherapy and those with unfit status according to Ferrara 2013 criteria. In the fit cohort, patients will be randomized into accepting HVA versus IA/DA for induction with a ratio of 1:1. In the unfit cohort, patients will be randomized into accepting HVA versus VA for induction with a ratio of 1:1.
- Masking
- None (open label)
- Enrolment
- 876 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou First People's Hospital, Guangdong Second Provincial General Hospital, Jiangmen Central Hospital, Shenzhen Second People's Hospital, First Affiliated Hospital of Guangxi Medical University, Dongguan People's Hospital, First People's Hospital of Foshan, Guangdong Provincial Hospital of Traditional Chinese Medicine, Huizhou Municipal Central Hospital, Shenzhen Hospital of Southern Medical University, Affiliated Hospital of Guangdong Medical University, People's Hospital of Guangxi Zhuang Autonomous Region, First People's Hospital of Chenzhou, Hunan Provincial People's Hospital, Ganzhou City People's Hospital, First Affiliated Hospital of Gannan Medical University
- Responsible party
- Sponsor
- Investigators
- Guopan Yu, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810791
- Sponsor's protocol ID
- NFEC-2024-576
- Status last verified
- Feb 2025
- First submitted
- 16 Jan 2025
- Last updated
- 6 Feb 2025
- 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 6 Feb 2025. 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 Versus Standard Chemotherapy or VA in the Treatment of Acute Myeloid Leukemia With High-risk, a Multicenter, Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT06810791
- Acronym / sponsor ID
- NFEC-2024-576
- Keywords
- HVA regimen, Intensive chenmotherapy, Fit, randomized controlled trial, Phase 3, VEN combined with AZA, Unfit, Newly diagnosed
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 876 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou First People's Hospital, Guangdong Second Provincial General Hospital, Jiangmen Central Hospital, Shenzhen Second People's Hospital, First Affiliated Hospital of Guangxi Medical University, Dongguan People's Hospital, First People's Hospital of Foshan, Guangdong Provincial Hospital of Traditional Chinese Medicine, Huizhou Municipal Central Hospital, Shenzhen Hospital of Southern Medical University, Affiliated Hospital of Guangdong Medical University, People's Hospital of Guangxi Zhuang Autonomous Region, First People's Hospital of Chenzhou, Hunan Provincial People's Hospital, Ganzhou City People's Hospital, First Affiliated Hospital of Gannan Medical University
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Feb 2025 (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.
The aim of this study is to evaluate the safety and efficacy of homohartonine combined with venetoclax and azacitidine (HVA) versus intensive chemotherapy (IA/DA) or venetoclax combined with azacitidine (VA) in newly diagnosed high-risk AML patients.
Detailed description
The HVA regimen exerts a synergistic pro-apoptotic effect and has demonstrated significant clinical efficacy against R/R AML and also overcomes adaptive resistance observed in the VA regimen. Exploratory work with small sample sizes in first-line settings suggests that combination of HHT and Ven+AZA exhibits potent anti-AML effects with good safety profiles, particularly in overcoming the impact of high-risk factors associated with AML relative to standard treatments. This indicates its potential as a more ideal option for the treatment of newly diagnosed AML with high risk factors. Therefore a prospective, multi-center, randomized controlled clinical study is planned to evaluate the efficacy and safety of the HVA regimen compared to intensive chemotherapy (IA/DA) or Venetoclax plus azacitidine (VA) regimens in newly diagnosed high-risk fit-AML or unfit AML patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Patients with newly diagnosed AML with high risk will be divided into two cohorts, including patients being eligible for intensive chemotherapy and those with unfit status according to Ferrara 2013 criteria. In the fit cohort, patients will be randomized into accepting HVA versus IA/DA for induction with a ratio of 1:1. In the unfit cohort, patients will be randomized into accepting HVA versus VA for induction with a ratio of 1:1.
| Arm | Type | Receives |
|---|---|---|
| IC regiment for Fit-AML | Active comparator | Drug: Standard Chemotherapy |
| HVA regiment for Fit-AML | Experimental | Drug: HVA |
| VA regiment for unfit-AML | Active comparator | Drug: VA |
| HVA regiment for unfit-AML | Experimental | Drug: HVA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- According to the world health organization (WHO) classification of newly diagnosed with AML patients;
- Age ≥18 years old;
- High-risk patients should meet any of the following criteria: ① High risk group according to the European Leukemia Risk stratification (ELN) 2022; (2) Secondary AML (sAML) which develops from myelodysplastic syndrome (MDS), bone marrow hyperplastic tumor (MPN) or chronic myeloid cell leukemia, et.; (3) Treatment-related AML (t-AML), Patients have a history of cytotoxic treatment record or ionizing radiation therapy.
- Patients did not receive anti-AML therapy (except leukopenia therapy, such as hydroxyurea or cytarabine < 1.0g/d) after the diagnosis of AML;
- Expected survival ≥12 weeks;
Key exclusion criteria (10 listed)
- Acute promyelocytic leukemia;
- With central nervous system leukemia (CNSL) ;
- The cardiac function > level 2;
- The AIDS virus (HIV) infection;
- Other clinical significance of uncontrolled condition, including but not limited to: (1) out of control, or active systemic infection (viruses, bacteria or fungi); (2) chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) requiring treatment; (3) need to actively deal with the merger of the second tumor;
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 |
|---|---|---|
| HVAHomoharringtonine (HHT) is given by venous drip daily at 1 mg/m2 from day 1 to 7. Venetoclax (VEN) is given 100 mg on day 1, 200 mg on day 2, and 400 mg orally from day 3 to day 14. Azacitidine (AZA) is given 75 mg/m2 subcutaneously from day 1 to 7. | Drug | HVA regiment for Fit-AML, HVA regiment for unfit-AML |
| VAVEN is given 100 mg on day 1, 200 mg on day 2, and 400 mg orally from day 3 to day 28, and AZA (75 mg/m2) is given subcutaneously from day 1 to 7. | Drug | VA regiment for unfit-AML |
| Standard ChemotherapyStandard Chemotherapy includes IA(Idarubicin combined with Cytarabine) or DA(Daunorubicin combined with Cytarabine). IDA is given by venous drip daily at 12mg/m2, or DNR is given by venous drip daily at 60mg/m2, from day 1-3, combined with Ara-C at 100mg/m2 by continuously venous drip from day 1-7. | Drug | IC regiment for Fit-AML |
Primary outcome
Composite complete remission (CRc)
Time frame: At the end of cycle 2 (each cycle is 28 days).
CRc includes complete remission (CR) and complete remission accompanied with with incomplete count recovery (CRi).
7 secondary outcomes
Complete remission (CR)
Time frame: At the end of cycle 2 (each cycle is 28 days).
Overall response rate (ORR)
Time frame: At the end of cycle 2 (each cycle is 28 days).
DOR
Time frame: 1 year
Rate of Measurable residual disease (MRD) negative
Time frame: At the end of cycle 2 (each cycle is 28 days).
Overall survival (OS)
Time frame: 1 year
Event-free survival (EFS)
Time frame: 1 year
Adverse events (AE)
Time frame: The first dose until 28 days after treatment discontinuation
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 6 Feb 2025.
- 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.
Guopan Yu principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HVA, VA and Standard Chemotherapy in people with Newly Diagnosed Acute Myeloid Leukemia With High Risk, run by Nanfang Hospital, Southern Medical University 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 9 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 6 Feb 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Guopan Yu (+8615876559968, yugpp@163.com), or a site near the patient. 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 (each cycle is 28 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 6 Feb 2025.