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HAV Versus DAV/IAV Induction Regimen in Elderly Patients With AML
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Summary
Acute myeloid leukemia (AML) represents the most prevalent leukemia type in China. Elderly patients (≥60 years old) have a high incidence rate, accounting for over half of all AML patients, with a median age of onset approximately 68 years. Elderly AML patients have a poor prognosis and are often accompanied with multiple high-risk factors.The 5-year overall survival (OS) is only 3-8%. Before the advent of new targeted drugs, for elderly patients with newly diagnosed AML who were suitable for intensive chemotherapy, the most commonly used chemotherapy regimen remained the classic "3 + 7" regimen. However, the complete remission (CR) rate after induction was approximately 40-60%. The majority of elderly patients were not eligible for allogeneic hematopoietic stem cell transplantation, resulting in a relatively poor long-term survival for elderly AML patients . With the emergence of new targeted drugs, clinical studies both domestically and internationally have demonstrated that the combination of various targeted drugs and demethylating agents has achieved favorable efficacy in elderly/unsuitable for intensive chemotherapy patients with newly diagnosed AML, prolonging their survival. Previously, we initiated a multicenter, prospective, randomized controlled clinical study (registration number: NCT06066242). The aim was to explore the optimal induction regimen for elderly fit patients with newly diagnosed AML. Preliminary data revealed that the regimen of daunorubicin (DNR) or idarubicin (IDA) combined with cytarabine (Ara - C, DA/IA) + venetoclax (Ven, DAV/IAV) had a higher induction remission rate (77.3% )than the DA/IA "3 + 7" and Ven + azacitidine (AZA) regimens (45% - 59%). However, compared to the induction remission rate of young adult patients with newly diagnosed AML (\> 85%), further improvement is still required. Previous research data show that HHT enhances the inhibitory effect of Ara-c on DNA synthesis in tumor cells by influencing cell cycle regulation. The combination of HHT and Ven can jointly affect the apoptotic pathway and enhance cell apoptosis. Therefore, this study intends to establish a prospective, randomized controlled clinical trial to compare the induction remission rates of the HHT + Ara-c + Ven (HAV) regimen with the DAV/IAV regimen, which,based on previous data, had the highest induction remission rate .
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
60
Start Date
2025-01-21
Completion Date
2027-06-01
Last Updated
2025-05-30
Healthy Volunteers
No
Conditions
Interventions
daunorubicin
Used in combination with cytarabine and venetoclax for induction therapy in DAV.
Venetoclax
Used in combination with cytarabine and daunorubicin for induction therapy in DAV.
cytarabine
Used in combination with venetoclax and daunorubicin for induction therapy in DAV or used by intermediate does for consolidation therapy.
azacitidine
Used in combination with venetoclax for maintenance therapy.
Homoharringtonine
Used in combination with cytarabine and venetoclax for induction therapy in HAV.
Idarubicin
Used in combination with cytarabine and venetoclax for induction therapy in IAV.
Locations (1)
Blood Diseases Hospital
Tianjin, Tianjin Municipality, China