Efficacy of HMAs vs Intensive Chemotherapy in AML Guided by 5hmC MRD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

ThisPhase II interventional trial enrolls about 112 adults with newly diagnosed AML and compares induction therapy using hypomethylating agents versus intensive chemotherapy. The study uses a blood-based 5hmC marker in cell-free DNA to assess measurable residual disease after induction and to guide subsequent treatment decisions, including consolidation options. Patients are assigned to treatment arms by stratified sampling, with MRD status monitored at defined intervals and potential crossovers if MRD remains positive. Primary endpoints include MRD negativity rate, duration of remission, event-free survival, and overall survival. The trial is conducted at Houston Methodist’s Neal Cancer Center under The Methodist Hospital Research Institute.

Why it matters

Who can join: the full rules

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.

Where it's running

• Houston Methodist Neal Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Shilpan Shah, MD — Houston Methodist Neal Cancer Center
• Study coordinator: Danielle Sewell
• Email: dmsewall@houstonmethodist.org
• Phone: 3462382674

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.