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NCT Number: NCT06744556

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

AML

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300020, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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):
  • 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

  • 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:
  • 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);
  • Severe infectious diseases (untreated tuberculosis, pulmonary aspergillosis).
  • Those considered ineligible for enrollment by the researcher.

Treatment and study plan

Daunorubicin

Drug

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

Venetoclax

Drug

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

Cytarabine

Drug

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

Azacitidine

Drug

Used in combination with venetoclax for maintenance therapy.

Homoharringtonine

Drug

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

Idarubicin

Drug

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 20, 2024
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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