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ACTIVE NOT RECRUITING
NCT06744556
PHASE2

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

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

60 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

41

Start Date

2025-01-21

Completion Date

2028-06-01

Last Updated

2026-05-13

Healthy Volunteers

No

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.

Locations (1)

Blood Diseases Hospital

Tianjin, Tianjin Municipality, China