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

May 10, 2026 updated by: Institute of Hematology & Blood Diseases Hospital, China

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a multicenter, prospective, randomized, and controlled clinical trial, which intends to enroll elderly patients diagnosed with AML in accordance with the WHO (2022) or ICC standards and are suitable for intensive chemotherapy. For patients meeting the inclusion and not meeting the exclusion criteria, they will be randomly grouped and respectively receive induction therapy with either DAV/IAV (2 + 5) or HAV regimens. Patients achieving CR/CRi/CRh after induction treatment will undergo consolidation with the intermediate-dose cytarabine regimen for two courses.After completing the induction and consolidation therapy, maintenance therapy with the VA regimen for six courses will be administered; subsequently, follow-up will be conducted. Patients in the high-risk group and those with non-negative MRD are recommended to undergo allogeneic hematopoietic stem cell transplantation.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • 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
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300020
        • Blood Diseases 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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Conforming to the diagnostic criteria of AML or MDS/AML by WHO (2022) or ICC.
  2. Age ≥ 60 years and ≤ 75 years, regardless of gender.
  3. The performance status assessment of the Eastern Cooperative Oncology Group (ECOG-PS) is 0 - 2.
  4. 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.

Exclusion Criteria:

  1. Acute promyelocytic leukemia accompanied by the PML-RARA fusion gene
  2. Acute myeloid leukemia accompanied by the RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene
  3. Acute myeloid leukemia accompanied by the BCR-ABL fusion gene
  4. Retreated patients (referring to those who have previously undergone induction chemotherapy but can receive hydroxyurea for cytoreduction).
  5. Patients concurrently suffering from malignant tumors in other organs (requiring treatment).
  6. Active cardiac diseases, defined as one or more of the following:

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.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DAV/IAV

Induction 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.
Drug: daunorubicin
Used in combination with cytarabine and venetoclax for induction therapy in DAV.
Drug: Venetoclax
Used in combination with cytarabine and daunorubicin for induction therapy in DAV.
Drug: cytarabine
Used in combination with venetoclax and daunorubicin for induction therapy in DAV or used by intermediate does for consolidation therapy.
Drug: azacitidine
Used in combination with venetoclax for maintenance therapy.
Drug: Idarubicin
Used in combination with cytarabine and venetoclax for induction therapy in IAV.
Experimental: HAV

Induction 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
Drug: Venetoclax
Used in combination with cytarabine and daunorubicin for induction therapy in DAV.
Drug: cytarabine
Used in combination with venetoclax and daunorubicin for induction therapy in DAV or used by intermediate does for consolidation therapy.
Drug: azacitidine
Used in combination with venetoclax for maintenance therapy.
Drug: Homoharringtonine
Used in combination with cytarabine and venetoclax for induction therapy in HAV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free survival (EFS)
Time Frame: Up to approximately 1 years after the date of the last enrolled participants
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)
Up to approximately 1 years after the date of the last enrolled participants

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day postinduction mortality
Time Frame: Up to approximately 30 days
It is defined as death from any cause within 30 days after the start of induction.
Up to approximately 30 days
60-day postinduction mortality
Time Frame: Up to approximately 60 days
It is defined as death from any cause within 60 days after the start of induction.
Up to approximately 60 days
Complete remission (CR) rate or complete remission with partial hematologic recovery (CRh) rate or complete remission with incomplete hematologic recovery (CRi) rate
Time Frame: Up to approximately eight weeks afer induction therapy
Proportion of patients with CR, CRh or CRi
Up to approximately eight weeks afer induction therapy
Undectable Minimal residual disease (MRD) by flow cytometry compelete remission rates after induction
Time Frame: Up to approximately eight weeks afer induction therapy
Among those who have achieved CR/CRh/CRi after induction, proportion of patients who is undectable MRD by flow cytometry
Up to approximately eight weeks afer induction therapy
Undectable Minimal residual disease (MRD) by flow cytometry complete remission rates in the whole treatment
Time Frame: up to 1 years after the date of the last enrolled participants
Among those who have achieved CR/CRh/CRi in the whole treatment, proportion of patients who is undectable MRD by flow cytometry
up to 1 years after the date of the last enrolled participants
Relapse-free Survival (RFS)
Time Frame: Up to approximately 1 years after the date of the last enrolled participants
It is defined as the time from the start of achieving remission to disease progression, death from any cause or the last follow-up.
Up to approximately 1 years after the date of the last enrolled participants
overall survival
Time Frame: up to 1 years after the date of the last enrolled participants
The interval from the date of enrollment to the date of death or the date of last follow-up, whichever occurred first.
up to 1 years after the date of the last enrolled participants

Collaborators and Investigators

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

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

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 (Actual)

January 21, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

December 17, 2024

First Posted (Actual)

December 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 10, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2024095

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

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.

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