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

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 sche

Trial Details

NCT ID
NCT07060001
Phase
PHASE2
Sponsor
The Methodist Hospital Research Institute
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • 5hmC Biomarker
  • Venetoclax
  • Decitabine 20 mg/m²/day for 5 days
  • Azacitidine (AZA)
  • Cytarabine (Ara-C)
  • Anthracycline
Locations (sample)
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • The patient (or legally acceptable representative if applicable) provides written informed consent for the trial. Spanish speaking patients will be…
  • Male or female, 18 years of age or older, on the day of informed consent signing.
  • Newly diagnosed de novo AML
  • 5\. Expected life expectancy of at least 6 months 6. Willing and able to comply with the protocol for the duration of the trial including undergoin…

For full eligibility, visit ClinicalTrials.gov.

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