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

NCT06744556 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2026-05-13

No results posted yet for this study

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%.

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

Interventions

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

Homoharringtonine

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

DRUG

Idarubicin

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

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-21
Primary Completion
2027-12-01
Completion
2028-06-01

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06744556 on ClinicalTrials.gov