drugset / Trial / NCT06744556

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

NCT06744556

Phase 2 Active not recruiting 41 enrolled Institute of Hematology & Blood Diseases Hospital, China
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Daunorubicin Small molecule 60 mg/m2
Subject Homoharringtonine Small molecule 2 mg/m2
Comparator Idarubicin Small molecule 10 mg/m2
Background Azacitidine Other / unclassified 75 mg/m2
Background Cytarabine Small molecule 100 mg/m2
Background Cytarabine Small molecule 500 mg/m2
Background Cytarabine Small molecule 1000 mg/m2
Background Venetoclax Small molecule 400 mg