Reduced intensive 3 + 5 idarubicin and cytarabine chemotherapy plus venetoclax as first-line treatment for adults with acute myeloid leukaemia and high-risk myelodysplastic syndrome
Multiple clinical trials about chemotherapy plus venetoclax in primary diagnosed AML or relapsed/refractly AML were ongoing to attempt the facility of the combination. Zu et al demostrated that full dose of 3 + 7 daunorubicin and cytarabine chemotherapy plus 8 days escalated venetoclax acheived 91% of CR/CRi with 97% 1-year overall survival and 72% 1-year event-free survival. In this trial , we try to reduced the intensive of 3 + 5 idarubicin and cytarabine chemotherapy, but prolong venetoclax to two weeks in the induction therapy in adults AML/MDS. We expect to increase the induced remission rate by extending the dosage of targeted drug venetoclax, and minimize the side effects by reducing the dose of 3 + 7 induction chemotherapy, so as to achieve the goal of high efficiency and low toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Idarubicin 6mg/m2 d5-7
Cytarabine 60mg/m2 d5-9
CR
assessment of the composite complete remission rate (CR=CR+CRi)
Time frame: Week 6
MRD
assessment of bone marrow measurable residual disease by flow cytometry
Time frame: Week 6
EFS
Evaluate the event-free survival
Time frame: 2 years
OS
Evaluated the overall survival
Time frame: 2 years
adverse events
Monitor of adverse events
Time frame: at any time
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