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AMLPhase 2NCT06744556

HAV Versus DAV/IAV Induction Regimen in Elderly Patients With AML

A Phase 2 study testing daunorubicin, Venetoclax and cytarabine in people with AML, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Acute myeloid leukemia (AML) is the most common leukemia in China, with a high incidence in elderly patients (≥60 years), who comprise over half of all cases (median age ~68 years). Elderly AML patients have a poor prognosis and carry multiple high-risk factors, with a 5-year overall survival (OS) of only 3-8%. Read more about this study

Who is it for?
Ages 60 to 75 years
Conditions the study is for
AML
What is being tested?
daunorubicin, Venetoclax and cytarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteChina
Study dates
21 Jan 2025to 1 Jun 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 60 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Conforming to the diagnostic criteria of AML or MDS/AML by WHO (2022) or ICC.
  • Age ≥ 60 years and ≤ 75 years, regardless of gender.
  • The performance status assessment of the Eastern Cooperative Oncology Group (ECOG-PS) is 0 - 2.
  • Meeting the requirements of the following laboratory examination indicators (performed within 7 days before treatment):
  • 1) Total bilirubin ≤ 1.5 times the upper limit of normal for the same age group; 2) AST and ALT ≤ 2.5 times the upper limit of normal for the same age group; 3) Serum creatinine < 2 times the upper limit of normal for the same age group; 4) Cardiac enzymes < 2 times the upper limit of normal for the same age group; 5) The cardiac ejection fraction determined by echocardiography (ECHO) > 50%. The informed consent form must be signed before the initiation of all specific research procedures. It should be signed by the patient himself/herself or an immediate family member. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the informed consent form should be signed by the legal guardian or an immediate family member of the patient.

Who cannot join

  • Acute promyelocytic leukemia accompanied by the PML-RARA fusion gene
  • Acute myeloid leukemia accompanied by the RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene
  • Acute myeloid leukemia accompanied by the BCR-ABL fusion gene
  • Retreated patients (referring to those who have previously undergone induction chemotherapy but can receive hydroxyurea for cytoreduction).
  • Patients concurrently suffering from malignant tumors in other organs (requiring treatment).
  • Active cardiac diseases, defined as one or more of the following:
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  • 1) Uncontrolled or symptomatic angina pectoris history; 2) Myocardial infarction less than 6 months from the time of enrollment in the study; 3) History of arrhythmias requiring drug treatment or with severe clinical symptoms; 4) Uncontrolled or symptomatic congestive heart failure (> NYHA Grade 2);
  • 7. Severe infectious diseases (untreated tuberculosis, pulmonary aspergillosis).
  • 8. Those considered ineligible for enrollment by the researcher.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Blood Diseases Hospital

    Tianjin, Tianjin Municipality, 300020

Other trials in China

About this study

Official title: HAV Versus DAV/IAV Induction Regimen in Elderly Patients With Acute Myeloid Leukemia Suitable for Intensive Chemotherapy: a Multicenter, Randomized, Controlled Clinical Trial

Acute myeloid leukemia (AML) is the most common leukemia in China, with a high incidence in elderly patients (≥60 years), who comprise over half of all cases (median age ~68 years). Elderly AML patients have a poor prognosis and carry multiple high-risk factors, with a 5-year overall survival (OS) of only 3-8%.

Before the era of novel targeted agents, the classic "3+7" regimen was the standard intensive chemotherapy for eligible elderly patients, yielding an induction complete remission (CR) rate of 40-60%. Long-term survival remained poor, as most elderly patients are not candidates for allogeneic hematopoietic stem cell transplantation.

Recent clinical studies have shown that combinations of novel targeted agents with hypomethylating agents improve outcomes in elderly or unfit patients. In a previously initiated multicenter, prospective, randomized controlled trial (NCT06066242), the investigators aimed to identify the optimal induction regimen for elderly fit patients with newly diagnosed AML. Preliminary data indicate that the DNR/IDA + Ara-C + venetoclax (DAV/IAV) regimen achieved a higher induction remission rate (77.3%) compared with DA/IA (3+7) or Ven + azacitidine (45-59%). However, this rate remains below that observed in younger adults (>85%), highlighting the need for further optimization.

Conditions
AML
Being tested
daunorubicin, Venetoclax, cytarabine, azacitidine, Homoharringtonine
Keywords
Elderly Patients

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • daunorubicinDrug

    Used in combination with cytarabine and venetoclax for induction therapy in DAV.

  • VenetoclaxDrug

    Used in combination with cytarabine and daunorubicin for induction therapy in DAV.

  • cytarabineDrug

    Used in combination with venetoclax and daunorubicin for induction therapy in DAV or used by intermediate does for consolidation therapy.

  • azacitidineDrug

    Used in combination with venetoclax for maintenance therapy.

  • HomoharringtonineDrug

    Used in combination with cytarabine and venetoclax for induction therapy in HAV.

  • IdarubicinDrug

    Used in combination with cytarabine and venetoclax for induction therapy in IAV.

Study groups in NCT06744556
Study groupRoleWhat they receive
DAV/IAVActive comparatorInduction therapy: Ara-C 100mg/m2/d, d1-5 Daunorubicin 60mg/m2/d, d1-2 or Idarubicin 10mg/m2/d, d1-2 Venetoclax 100mg d3, 200mg d4,400mg d5-11 If the treatment achieves CR/CRi/CRh, proceed directly to consolidation therapy. If the treatment does not achieve CR/CRi/CRh, enter the second induction phase with a different treatment regimen. Second Induction Phase: For patients with FLT3 or IDH1 mutations, targeted therapy can be chosen. If there is no FLT3 or IDH1 mutation or the patient is unwilling to use FLT3 or IDH1 inhibitors, switch to the HAV induction regimen. Consolidation therapy: 1. intermediate-dose Ara-C (ID-Ara-C): 2 cycles are used. Ara-C 1 g/m2/q12h on days 1, 3, and 5 (for patients aged 60-70 years) or Ara-C 500 mg/m2/q12h on days 1, 3, and 5 (for patients aged 70 years or older) Maintenance therapy: VA regimen: 6 courses Azacitidine 75 mg/m2/d on days 1-5, Venetoclax 400 mg on days 1-7.
Receives: Drug: daunorubicin; Drug: Venetoclax; Drug: cytarabine; Drug: azacitidine; Drug: Idarubicin
HAVExperimentalInduction Therapy: Ara-C 100mg/m2/d, d1-5 HHT 2mg/m2/d, d1-5 Venetoclax 100mg d3, 200mg d4,400mg d5-11 If CR/CRi/CRh is achieved, proceed directly to consolidation therapy. If the treatment does not reach CR/CRi/CRh, enter the second induction phase with a different treatment regimen. Second course: For patients with FLT3 or IDH1 mutations, the corresponding targeted therapy can be selected, as before. For patients without FLT3 or IDH1 mutations or those who do not want to use FLT3 or IDH1 inhibitors, the DAV/IAV induction regimen is changed. If the treatment does not reach CR/CRi/CRh after two courses, the patient is discharged. Consolidation therapy: 1. intermediate-dose Ara-C (ID-Ara-C): 2 cycles are used. Ara-C 1 g/m2/q12h on days 1, 3, and 5 (for patients aged 60-70 years) or Ara-C 500 mg/m2/q12h on days 1, 3, and 5 (for patients aged 70 years or older) Maintenance therapy: VA : 6 courses
Receives: Drug: Venetoclax; Drug: cytarabine; Drug: azacitidine; Drug: Homoharringtonine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free survival (EFS)

    It is defined as the time from the start of randomization to the occurrence of induction failure or disease progression or death from any cause (whichever occurs first)

    Measured: Up to approximately 1 years after the date of the last enrolled participants

Secondary outcomes (7)

  1. Complete remission (CR) rate or complete remission with partial hematologic recovery (CRh) rate or complete remission with incomplete hematologic recovery (CRi) rate

    Proportion of patients with CR, CRh or CRi

    Measured: Up to approximately eight weeks afer induction therapy

  2. Undectable Minimal residual disease (MRD) by flow cytometry compelete remission rates after induction

    Among those who have achieved CR/CRh/CRi after induction, proportion of patients who is undectable MRD by flow cytometry

    Measured: Up to approximately eight weeks afer induction therapy

  3. Undectable Minimal residual disease (MRD) by flow cytometry complete remission rates in the whole treatment

    Among those who have achieved CR/CRh/CRi in the whole treatment, proportion of patients who is undectable MRD by flow cytometry

    Measured: up to 1 years after the date of the last enrolled participants

  4. Relapse-free Survival (RFS)

    It is defined as the time from the start of achieving remission to disease progression, death from any cause or the last follow-up.

    Measured: Up to approximately 1 years after the date of the last enrolled participants

  5. 30-day postinduction mortality

    It is defined as death from any cause within 30 days after the start of induction.

    Measured: Up to approximately 30 days

  6. 60-day postinduction mortality

    It is defined as death from any cause within 60 days after the start of induction.

    Measured: Up to approximately 60 days

  7. overall survival

    The interval from the date of enrollment to the date of death or the date of last follow-up, whichever occurred first.

    Measured: up to 1 years after the date of the last enrolled participants

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2024
  2. Study start21 Jan 2025
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06744556
Sponsor's protocol ID
IIT2024095
Status last verified
May 2026
First submitted
17 Dec 2024
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing daunorubicin, Venetoclax and cytarabine in people with AML, run by Institute of Hematology & Blood Diseases Hospital, China 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 5 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 13 May 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?

Event-free survival (EFS) (time frame: Up to approximately 1 years after the date of the last enrolled participants). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06744556.

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 13 May 2026.

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