Could a liver-protecting herb boost leukemia chemo? new trial aims to find out.
NCT ID NCT07561892
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for adults newly diagnosed with a type of acute myeloid leukemia (non-M3). It tests whether adding silibinin, a natural compound from milk thistle that protects the liver, to standard chemotherapy can improve remission rates and survival. About 100 participants will be randomly assigned to receive chemo with or without silibinin. The goal is to see if the combination is safer and more effective.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Newly diagnosed acute leukemia(non-M3)confirmed according to the 2018 WHO classification criteria for the diagnosis and classification of acute leukemia; 2. Suitable for standard chemotherapy regimens containing idarubicin/daunorubicin; 3. Patients with an expected survival time of at least 3 months as determined by the investigator; 4. Voluntarily agree to participate in this study and sign the informed consent form. Exclusion Criteria: 1. History of other malignant tumors concurrently or previously diagnosed malignancies not under control; 2. Participation in other clinical trials within one month prior to screening; 3. Presence of uncontrolled cerebrovascular diseases, coagulation disorders, connective tissue diseases, or other such conditions; 4. Other uncontrolled diseases that the investigator considers inappropriate for inclusion; 5. Patients with psychiatric disorders or other known or suspected inability to fully comply with the study protocol; 6. Pregnant or breastfeeding women; 7. History of liver cirrhosis, or current active liver disease or biliary disease; 8. HIV-positive individuals; 9. Any other conditions that, in the investigator's judgment, may prevent the subject from completing the study or pose significant risk to the subject.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fujian Medical University Union Hospital
RECRUITINGFuzhou, Fujian, 350001, China
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