Study Comparing Two Treatments for Acute Myeloid Leukemia Using a New Blood Test
Sponsor: The Methodist Hospital Research Institute
ClinicalTrials ID:NCT07060001
This clinical trial is testing two different treatments for newly diagnosed acute myeloid leukemia (AML) in adults, using a new blood test to help guide treatment decisions. The study aims to see which treatment is more effective in reducing the disease and improving survival rates.
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Program Overview
This study is exploring two treatment options for adults with newly diagnosed acute myeloid leukemia (AML). Researchers are using a new blood test to measure a marker called 5-hydroxymethylcytosine (5hmC) in cell-free DNA, which helps assess how much of the disease remains after treatment. The trial compares the effectiveness of two treatments: one using hypomethylating agents (HMA) and the other using intensive chemotherapy. The goal is to determine which treatment is better at reducing the disease and improving patient outcomes, such as remission duration and survival rates. About 112 patients will participate, and blood samples will be collected at specific times to monitor the disease.
Description
This clinical trial is testing two different treatments for adults with newly diagnosed acute myeloid leukemia (AML). The study uses a new blood test to measure a marker called 5-hydroxymethylcytosine (5hmC) in cell-free DNA, which helps assess how much of the disease remains after treatment. Participants will receive either a treatment based on hypomethylating agents (HMA) or intensive chemotherapy. The study will compare the effectiveness of these treatments in reducing the disease and improving outcomes like remission duration and survival rates.
Patients will be assigned to one of the two treatment groups, and about 112 participants will be involved. Blood samples will be collected at specific times to monitor the disease. If the blood test shows that the disease is still present after initial treatment, patients may switch to the other treatment group. If the test shows no disease, patients will continue with their current treatment or proceed to further therapy.
The study aims to determine which treatment is more effective in reducing the disease and improving patient outcomes. All procedures will be conducted according to standard medical care, and participants will be closely monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older with newly diagnosed acute myeloid leukemia (AML).
- Must provide written informed consent to participate in the study.
- Expected to live at least 6 months.
- Willing to follow the study protocol, including attending scheduled visits and undergoing treatment.
- Women of childbearing potential and men must agree to use effective birth control methods during the study and for a specified period after the last dose of treatment.
Exclusion Criteria
- Currently participating in another study or have recently participated in a study involving an investigational treatment or device.
- Have serious or uncontrolled medical conditions that would prevent participation in the study.
- Have psychiatric or substance abuse disorders that would interfere with the study requirements.
- Women who are pregnant or have a confirmed positive pregnancy test.
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