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NCT07060001 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by The Methodist Hospital Research Institute.

Not yet
Registry status
Phase 2
Development phase
112
Enrollment target

NCT07060001 is a Phase 2 study that has not yet begun recruiting, run by The Methodist Hospital Research Institute. The registered enrollment target is 112 participants.

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The verdict

NCT07060001, a Phase 2 study, has not yet begun recruiting, sponsored by The Methodist Hospital Research Institute.

NOT YET RECRUITING
Registry status
Phase 2
Development phase
112 participants
Enrollment target

Study Summary

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).

Interventions

  • DRUG Venetoclax
  • DRUG Azacitidine (AZA)
  • DRUG Cytarabine (Ara-C)
  • DIAGNOSTIC_TEST 5hmC Biomarker
  • DRUG Decitabine 20 mg/m²/day for 5 days

Trial Details

FieldValue
Enrollment Target 112 participants
Start Date 2026-04
Est. Completion 2029-12
Phase Phase 2

What the Registry Record Tells You About NCT07060001

The ClinicalTrials.gov registry entry for NCT07060001 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Methodist Hospital Research Institute, which has 126 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Venetoclax is the first listed.

NCT07060001 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT07060001 about?

NCT07060001 is a clinical study titled "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 ...

What is the current status of trial NCT07060001?

This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 112 participants. The study started on 2026-04. Estimated completion is 2029-12.

What interventions are being tested in trial NCT07060001?

The interventions under investigation include: Venetoclax (DRUG), Azacitidine (AZA) (DRUG), Cytarabine (Ara-C) (DRUG), 5hmC Biomarker (DIAGNOSTIC_TEST), Decitabine 20 mg/m²/day for 5 days (DRUG).

Who is sponsoring clinical trial NCT07060001?

This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.