Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 2 study, sponsored by The Methodist Hospital Research Institute.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
cfDNA 5hmC-MRD negativity and positivity rates at the time of morphologic remission.
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
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2026-04 |
| Est. Completion | 2029-12 |
| Phase | Phase 2 |
What is known before NCT07060001 opens enrollment
NCT07060001 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower).
The record links to 0 conditions, and to 5 interventions - of which Venetoclax is the first listed.
NCT07060001 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07060001's enrollment target sits among peer trials
112 631st of 2000 higher than 1,369 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04511013 · 112 participants · Phase 2
A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases
- NCT04551560 · 112 participants · NA
Stress and Congestive Heart Failure
- NCT04872166 · 112 participants · Phase 1
A Study of BTX-A51 in People With Advanced Solid Tumor and Breast Cancer
- NCT05024773 · 112 participants · Phase 3
Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia