The optimal induction chemotherapy regimen for newly diagnosed elderly AML patients who are eligible for intense chemotherapy is currently not well defined. Thus, we intend to conduct a multicenter, randomized, controlled clinical trial to compare the safety and efficacy of three different induction regimens (Ven+AZA vs DA/IA 3+7 vs DA/IA 2+5+VEN). A total of 90 patients will be enrolled in this study and segregated into thress groups with 30 in each group. Patients who achieve CR/CRi/CRh after using different induction regimens will receive the same consolidation and maintenance therapy. Allogeneic hematopoietic stem cell transplantation is recommended for patients in the high-risk group or those with persist MRD positivity. After completion of the treatment phase, patients entered the follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
azacitidine combined with venetoclax or chemotherapy with or without venetoclax
Institute of Hematology & Blood Diseases Hospital
Tianjin, China
RECRUITINGEvent-free survival (EFS)
It is defined as the time from the start of randomization to the occurrence of induction failure or disease progression or death from any cause (whichever occurs first).
Time frame: Up to approximately 2 years
Complete remission (CR) rate or complete remission with partial hematologic recovery (CRh) rate or complete remission with incomplete hematologic recovery (CRi) rate
Proportion of patients with CR, CRh or CRi
Time frame: Up to approximately eight weeks
Minimal residual disease (MRD)-negative remission rates after induction
Among those who have achieved CR/CRh/CRi after induction, proportion of patients who is MRD-negative
Time frame: Up to approximately eight weeks
Cumulative incidence of minimal residual disease (MRD)-negative remission rates
The proportion of patients with negative MRD results at any time during treatment
Time frame: Up to approximately 1 years
Relapse-free Survival (RFS)
It is defined as the time from the start of achieving remission to disease progression, death from any cause or the last follow-up.
Time frame: Up to approximately 2 years
Overall survival (OS)
It is defined as the time from the start of randomization to the death from any cause.
Time frame: Up to approximately 2 years
30-day postinduction mortality
It is defined as death from any cause within 30 days after the start of induction.
Time frame: Up to approximately 30 days
60-day postinduction mortality
It is defined as death from any cause within 60 days after the start of induction.
Time frame: Up to approximately 60 days
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