OncoMatch/Clinical Trials/NCT06379360
Maintenance Therapy of Hypomethylating Agent (HMA) in Favorable Risk Acute Myeloid Leukemia (AML) Patients
Is NCT06379360 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Hypomethylating agent, Azacitidine or Decitabine for acute myeloid leukemia.
Treatment: Hypomethylating agent, Azacitidine or Decitabine — HMA maintenance therapy is expected to benefit overall survival (OS) and relapse free survival (RFS) in AML patients with favorable risk.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Allowed: NPM1 mutation
For NPM1-mutated ... MRD negative is defined as <2%
Allowed: RUNX1T1 fusion
core binding factor acute myeloid leukemia (CBF-AML), MRD negative is defined as <2%
Allowed: CBFB fusion
core binding factor acute myeloid leukemia (CBF-AML), MRD negative is defined as <2%
Allowed: CEBPA mutation
CEBPA-mutated AML, MRD negative is defined as <0.1%
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: induction therapy
Patients achieved remission after induction therapy
Must have received: high-dose Aar-C based consolidation therapy
finished at least 3 cycles of high-dose Aar-C based consolidation therapy
Cannot have received: hematopoietic stem cell transplantation
Patients not receiving hematopoietic stem cell transplantation prior to enrollment
Lab requirements
Kidney function
serum creatinine > 1.5x ULN
Liver function
total bilirubin > 1.5x ULN, ALT/AST > 2.5x ULN (or >1.5x ULN with liver involvement)
Cardiac function
QTc prolongation (male > 450 ms; female > 470 ms), ventricular tachycardia, atrial fibrillation, II-degree heart block, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease requiring drug treatment
Liver function abnormalities (total bilirubin > 1.5 times the upper limit of the normal range, Alanine Aminotransferase (ALT) / Aspartate Aminotransferase (AST) > 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST > 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine > 1.5 times the upper limit of the normal value). ... history of clinically significant Corrected QT Interval (QTc) prolongation (male > 450 ms; female > 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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