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Efficacy of Hypomethylating Agents vs. Intensive Chemotherapy in Acute Myeloid Leukemia Using 5hmC as a Blood-Based Minimal Residual Disease Marker

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Start date changed from estimate of Apr 2026 to Apr 9, 2026 · Interventions: 5hmC Biomarker (Diagnostic Test), Anthracycline (Drug), Azacitidine (AZA) (Drug), Cytarabine (Ara-C) (Drug), Decitabine 20 mg/m²/day for 5… to 5hmC Biomarker (Diagnostic Test), Anthracycline (Drug), Azacitidine (AZA) (Drug), Cytarabine (Ara-C) (Drug), Decitabine 20 mg/m²/day for 5… · Eligibility criteria expanded, about 10 words · 4 more Show 7 more changesShow less
    • Start date changed from estimate of Apr 2026 to Apr 9, 2026
    • Interventions: 5hmC Biomarker (Diagnostic Test), Anthracycline (Drug), Azacitidine (AZA) (Drug), Cytarabine (Ara-C) (Drug), Decitabine 20 mg/m²/day for 5… to 5hmC Biomarker (Diagnostic Test), Anthracycline (Drug), Azacitidine (AZA) (Drug), Cytarabine (Ara-C) (Drug), Decitabine 20 mg/m²/day for 5…
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description revised
    • Site details revised
    • Publications: details revised at 62 of 63 entries
  2. Start date: Jul 2025 to Apr 2026v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a therapeutic intervention trial evaluating the clinical utility of a novel blood-based epigenetic biomarker-genome-wide 5-hydroxymethylcytosine (5hmC) in cell-free DNA (cfDNA)-for assessing measurable residual disease (MRD) in patients with newly diagnosed acute myeloid leukemia (AML). The study compares the efficacy of hypomethylating agent (HMA)-based therapy versus intensive induction chemotherapy, using the 5hmC biomarker to guide post-induction treatment decisions. Approximately 112 adult patients will be enrolled and assigned to treatment arms based on a stratified sampling scheme. Blood samples will be collected at defined intervals to assess MRD status. Primary endpoints include minimal residual disease (MRD) negativity rate, duration of remission, event-free survival (EFS), and overall survival (OS).
Trial Details
NCT Number NCT07060001
Lead Sponsor The Methodist Hospital Research Institute
Conditions Acute Myeloid Leukemia (AML), Acute Myeloid Leukaemia (AML)
Enrollment 112 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov