RecruitingPhase IIEN originalLeukemia

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

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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).

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Wiek 18 lat lub więcej
  • •Nowo rozpoznana białaczka ostroszpikowa
  • •Oczekiwana długość życia co najmniej 6 miesięcy
  • •Chęć i zdolność udziału w badaniu przez cały okres trwania
  • •Kobiety mogą uczestniczyć po negatywnym teście ciąży
  • •Zgoda na stosowanie antykoncepcji podczas badania i przez 6 miesięcy po jego zakończeniu

✗ Disqualifies

  • •Uczestnictwo w innym badaniu leków eksperymentalnych w ostatnich 3 tygodniach
  • •Poważne schorzenia towarzyszące, które mogą uniemożliwić uczestnictwo
  • •Zaburzenia psychiatryczne lub uzależnienia mogące zakłócić współpracę
  • •Potwierdzony dodatni test ciąży

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
October 8, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (1)

Houston Methodist Neal Cancer Center

Houston, United States

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/9/2026.

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