AML, Adult
Conditions
Keywords
acute myeloid leukemia, Older fit patients, venetoclax
Brief summary
This study is a multicenter, randomized, controlled phase III clinical trial aimed at comparing the efficacy of two induction chemotherapy regimens-VA (Venetoclax + Azacitidine) and D/IA (Daunorubicin/Idarubicin + Cytarabine)-in elderly patients (aged 55-75) with acute myeloid leukemia (AML) who are fit for intensive chemotherapy.
Interventions
DRUGDaunorubicin/Idarubicin
Daunorubicin/Idarubicin is used in Induction Therapy and Maintenance Therapy.
DRUGCytarabine
Cytarabine is used in Induction Therapy, Consolidation Therapy and Maintenance Therapy.
DRUGAzacitidine
Azacitidine is used in VA regimen
DRUGVenetoclax
Venetoclax is used in VA regimen
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of AML according to WHO (2022) or ICC criteria. * Age ≥55 and ≤75 years. * ECOG performance status score of 0-2. * Adequate organ function: * Total bilirubin ≤1.5× upper limit of normal (ULN) * AST and ALT ≤2.5× ULN * Serum creatinine \<2× ULN * Cardiac enzymes \<2× ULN * Left ventricular ejection fraction (LVEF, by echocardiogram) within normal range Signed informed consent by the patient or legal representative.
Exclusion criteria
* Acute promyelocytic leukemia with PML-RARA fusion gene. * AML with RUNX1-RUNX1T1 or CBFB-MYH11 fusion genes. * AML with BCR-ABL fusion gene. * Relapsed or refractory AML (previously treated with induction chemotherapy, but hydroxyurea is allowed). * Concurrent other malignancies requiring treatment. * Active cardiac disease (e.g., uncontrolled angina, recent myocardial infarction, severe arrhythmias, uncontrolled heart failure, LVEF below normal). * Severe infectious diseases (e.g., untreated tuberculosis, pulmonary aspergillosis). * Other conditions deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | up to 1 years after completion of enrollment | Time from randomization to death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite Complete Remission Rate (CR/CRh/CRi) | Six weeks after induction therapy | Proportion of patients achieving CR, CRh, or CRi after induction. |
| MRD Negativity Rate | up to 1 years after completion of enrollment | Proportion of patients achieving MRD negativity after induction and overall treatment. |
| Relapse-Free Survival (RFS) | up to 1 years after completion of enrollment | Time from achieving CR/CRh/CRi to relapse or death. |
| Event-Free Survival (EFS) | up to 1 years after completion of enrollment | Time from randomization to treatment failure, relapse, or death. |
| 30-Day and 60-Day Mortality Rates | within 30 and 60 days of starting treatment. | Proportion of patients who die within 30 and 60 days of starting treatment. |
Countries
China
Contacts
CONTACTHui Wei, MD
PRINCIPAL_INVESTIGATORHui Wei, MD
Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Outcome results
None listed