A Phase 2 interventional study of venetoclax, azacitidine and HAAG regimen in Intermediate Risk Acute Myeloid Leukemia and High Risk Acute Myeloid Leukemia, sponsored by The First Affiliated Hospital of Soochow University. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-01.
Sponsored by The First Affiliated Hospital of Soochow University · Phase 2, Interventional, and Treatment
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.
This is a single-center, single-arm, prospective clinical study in newly diagnosed intermediate and high-risk AML patients. The patients will receive venetoclax, azacitidine combined with HAAG regimen in the induction treatment.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 60 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.
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Exclusion Criteria:
This cohort will determine the safety and efficacy of venetoclax, azacitidine combined with HAAG regimen in newly diagnosed intermediate and high-risk AML patients.
Drug: venetoclax, azacitidine and HAAG regimen
Venetoclax: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;
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.
Time frame: Day 28-35 of induction course
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.
Time frame: Day 28-35 of induction course
Number of adverse events
adverse events are evaluated with CTCAE V5.0.
Time frame: 2 years
Relapse-free survival (RFS)
time from clinical CRc (CR and CRi) to the first relapse or death
Time frame: 3 years
Overall survival (OS)
time from the first day of treatment to death or lost to follow-up for any cause.
Time frame: 3 years
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The First Affiliated Hospital of Soochow University