About this trial
The purpose of this study is to evaluate the efficacy and safety of VA combined with HAAG in the induction treatment of newly diagnosed acute myeloid leukemia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Newly diagnosed intermediate and high-risk AML according to the WHO (2022) classification of acute myeloid leukemia (non-APL).
Age 18-65.
ECOG score: 0-2.
No history of previous chemotherapy or target therapy.
Disqualifiers
AML transformed with chronic myelogenous leukemia.
Acute promyelocytic leukemia (type M3).
Patients with a second malignancy requiring treatment.
Patients with uncontrolled active infection.
Trial design
Single group
Treatments tested in this trial
venetoclax, azacitidine and HAAG regimen
DrugVenetoclax:100mg, qd, d1;200mg, qd, d2;400 mg, qd, d3\~10, per os; Azacitidine:75mg/m2/d, d1\~7, subcutaneous injection; Homoharringtonine:1mg/d, d4\~10, intravenous infusion; Aclarubicin:10mg/d, d4\~7, intravenous infusion; Cytarabine:10mg/m2,q12h,d4\~10, subcutaneous injection; Granulocyte colony-stimulating factor (G-CSF): 50-300μg/d (when WBC counts are less than 20×10\^9/L ),subcutaneous injection;
Treatment groups
Trial outcomes
Primary outcomes
Composite complete response rate (CRc; CR+CRi)
CRc includes complete response CR and CRi; CR was defined as \< 5% bone marrow blasts in an aspirate with spicules, no blasts with Auer rods or persistence of extramedullary disease, and independent of transfusions; CRi: was defined as\<5% bone marrow blasts, either ANC\<1×10\^9/L or platelets\<100×10\^9/L, transfusion independence but with persistence of cytopenia.
Secondary outcomes
Partial remission (PR)
PR was defined as decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow aspirate and the normalization of blood counts.
Number of adverse events
adverse events are evaluated with CTCAE V5.0.
Relapse-free survival (RFS)
time from clinical CRc (CR and CRi) to the first relapse or death
Overall survival (OS)
time from the first day of treatment to death or lost to follow-up for any cause.
Sponsors and contacts
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