Phase 2Recruiting
Efficacy of Hypomethylating Agents vs. Intensive Chemotherapy in Acute Myeloid Leukemia Using 5hmC as a Blood-Based Minimal Residual Disease Marker
Evaluation of the Efficacy of Hypomethylating Agent Versus Standard Intensive Chemotherapy Induction Based on 5hmC - a Novel, Blood Epigenetic Marker for Assessing Measurable Residual Disease in Patients With Acute Myeloid Leukemia
- Sponsor
- The Methodist Hospital Research Institute (Academic or other)
- Enrolment
- 112 planned
- Conditions
- Acute Myeloid Leukemia (AML); Acute Myeloid Leukaemia (AML)
- Interventions
- 5hmC Biomarker; Venetoclax; Decitabine 20 mg/m²/day for 5 days; Azacitidine (AZA); Cytarabine (Ara-C); Anthracycline
- Ages
- adults, older adults
- Registry
- NCT07060001
Full record on ClinicalTrials.gov
From the registry
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).
Primary outcomes
- 5hmC Minimal Residual Disease Rates
- Duration of Remission (DoR) Based on 5hmC-MRD Status
- Event-Free Survival (EFS) by 5hmC-MRD Status
- Overall Survival (OS) in Relation to 5hmC-MRD
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered