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RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Blood samples will be collected at defined intervals to assess MRD status."
  • "For patients receiving HMA-based treatment, blood samples will be collected ± 5 days before and after 4 and 12 weeks of therapy."
  • "For patients receiving intensive chemotherapy blood samples will be collected ± 5 days before and after 4 and 12 weeks of therapy."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults with newly diagnosed acute myeloid leukemia (AML), a blood cancer. It compares treatment with drugs called hypomethylating agents (HMAs) with intensive chemotherapy. It also tests whether a blood marker called 5hmC can find small amounts of cancer left after treatment and help guide the next treatment.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have newly diagnosed AML that did not develop from an earlier blood disease.
  • You or your legal representative must give written consent. Spanish-speaking patients can join, with translation help as needed.
  • Be expected to live at least 6 months.
  • Be willing and able to follow study rules, receive treatment, and attend planned visits and exams.
  • Women who can become pregnant must have a negative blood pregnancy test.
  • Women who can become pregnant and men must follow the birth control rules during treatment and afterward: 6 months for women and 3 months for men. Options are no sex at all, a partner who has had surgery to prevent pregnancy, or two effective birth control methods, including one highly effective method.

Who can't join

  • Be receiving treatment in another study, or have received an experimental treatment or used an experimental device within 3 weeks before trial treatment.
  • Have a serious or uncontrolled health problem that the study doctor thinks would prevent you from taking part.
  • Have a known mental health or substance use problem that would keep you from following study requirements.
  • Have a confirmed positive pregnancy test.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. The patient (or legally acceptable representative if applicable) provides written informed consent for the trial. Spanish speaking patients will be included and translation services will be provided as needed. 2. Male or female, 18 years of age or older, on the day of informed consent signing. 3. Newly diagnosed de novo AML 5\. Expected life expectancy of at least 6 months 6. Willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits and examinations. 7. Women with childbearing potential and men should practice at least one of the following methods of birth control throughout the study and for 6 for women and 3 months for men after the last dose of study therapy: 1. Total abstinence from sexual intercourse (periodic abstinence not acceptable); 2. Surgically sterile partner(s) including vasectomy, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy; 3. Practicing 2 effective methods of contraception (at least 1 highly effective, method of contraception \[See Appendix 4\]). WOCBP should only be included after a confirmed negative serum pregnancy test. Exclusion Criteria: 1. Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 3 weeks of trial treatment administration. 2. The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study 3. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 4. Confirmed positive pregnancy test in WOCBP.

Study sites (1)

TX