300 patients will be randomly distributed into the control group (n=150) and the experimental group(n=150). Patients will receive two cycles of induction chemotherapy. The control group receives standard 3+7 induction regimen containing cytarabine (100mg/m2 d1-7) and daunorubicin (60mg/m2 d1-3). The experimental group receives venetoclax combined with intensive chemotherapy (3+7 induction regimen same as the control group). For each group, patients who fail to achieve CR/CRi after two courses of induction therapy may receive alternative therapy decided by their physicians. After CR/CRi achieved, subjects proceed allo-transplantation or consolidation therapy according to their ELN risks: subjects in favorable risk group should continue with chemotherapy; subjects in poor risk group should go through transplantation; for subjects in intermediate risk group, those with suitable donors can receive transplantation while others can continue with consolidation therapy. Subjects receive 3 courses of intermediate-dose cytarabine (1.5g/m2 q12h d1, 3, 5) for age\>55 years or high dose cytarabine (3g/m2 q12h d1, 3, 5) for age≤ 55 years as consolidation therapy with venetoclax in experimental group and without venetoclax in control group. After consolidation, patients will be observed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
312
Bcl-2 inhibitor
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Event-free survival
The time from randomization to treatment failure, death from any cause or relapse after achieving CR or CRi, whichever occurs first.
Time frame: up to 12 months
Overall survival Overall survival
The time from randomization to death resulting from any cause
Time frame: up to 36 months
CR rate
The proportion of patients achieving CR after two cycles of induction chemotherapy.
Time frame: up to 2 months
Rates of remission (CR/CRi) without measurable residual disease (CRMRD-)
The proportion of AML patients achieving CR/CRi with negativity for a genetic marker by real-time quantitative polymerase chain reaction and/or with negativity by multi-color flow cytometry.
Time frame: up to 2 months
Relapse free survival
From the date of complete remission(CR) until the date of documented relapse or death due to any cause or the last follow-up day.
Time frame: up to 36 months
Cumulative incidence of relapse
Calculated from tdate of first CR to the date of relapse, considering nonrelapse mortality (NRM) as a competing event
Time frame: up to 36 months
Frequency and severity of AEs
Adverse clinical events in the course of drug treatment according to CTCAE v5.0.
Time frame: up to 8 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.