Evaluating AML Treatments Using a New Blood Test
This study is looking at how well different treatments for newly diagnosed acute myeloid leukemia (AML) work, specifically comparing treatments that use hypomethylating agents (like Decitabine or Azacitidine) with intensive chemotherapy (like Cytarabine, sometimes with Venetoclax). The main goal is to see if a new blood test, called 5hmC, can help doctors decide the best treatment after the first round of therapy. This test looks for very small amounts of cancer cells remaining (minimal residual disease or MRD). The study will enroll about 112 adults with newly diagnosed AML. Researchers will measure how long patients stay in remission and how long they live without the disease coming back, based on the results of the 5hmC test. The study status is currently unclear.
- Study design
- This is an interventional study involving about 112 adult participants with newly diagnosed AML. Participants will be assigned to receive either hypomethylating agent-based treatment or intensive chemotherapy.
- What's involved
- You would receive standard-of-care therapy, and blood samples would be collected at specific times to check for the 5hmC biomarker. The 5hmC test will guide treatment decisions after the initial therapy.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed from the start of treatment until disease progression, unacceptable side effects, or withdrawal, for up to 30 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Efficacy of Hypomethylating Agents vs. Intensive Chemotherapy in Acute Myeloid Leukemia Using 5hmC as a Blood-Based Minimal Residual Disease Marker
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Shilpan Shah, MD · PRINCIPAL_INVESTIGATOR · Houston Methodist Neal Cancer Center
Who to contact
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What this trial measures
- 5hmC Minimal Residual Disease RatesFrom date of initial treatment until progression, unacceptable toxicity, treating physician's discretion, or patient withdraws, whichever comes first, assessed up to 30 months.
cfDNA 5hmC-MRD negativity and positivity rates at the time of morphologic remission.
- Duration of Remission (DoR) Based on 5hmC-MRD StatusFrom date of initial treatment until progression, unacceptable toxicity, treating physician's discretion, or patient withdraws, whichever comes first, assessed up to 30 months.
Time from initial treatment to disease relapse or progression, stratified by 5-hydroxymethylcytosine minimal residual disease (5hmC-MRD) status (positive vs. negative). This measure evaluates the impact of 5hmC-MRD on the sustainability of remission.
- Event-Free Survival (EFS) by 5hmC-MRD StatusFrom date of initial treatment until progression, unacceptable toxicity, treating physician's discretion, or patient withdraws, whichever comes first, assessed up to 30 months.
Time from treatment initiation to the occurrence of any treatment failure event, including relapse, progression, or death from any cause, compared between patients with positive and negative 5hmC-MRD. This outcome assesses the prognostic value of 5hmC-MRD in predicting treatment durability.
- Overall Survival (OS) in Relation to 5hmC-MRDFrom date of initial treatment until progression, unacceptable toxicity, treating physician's discretion, or patient withdraws, whichever comes first, assessed up to 30 months.
Time from diagnosis or treatment start to death from any cause, analyzed by 5hmC-MRD status. This outcome measure determines whether 5hmC-MRD positivity is associated with reduced overall survival.