Acute Myeloid LeukemiaPhase 4AMLNCT07561892
Study of the Effectiveness and Safety of Daunorubicin /Idarubicin ± Silibinin in Treating Newly Diagnosed AML (Non-M3).
A Phase 4 study testing daunomycin/Idarubicin+ Silybinin and daunomycin/Idarubicin in people with Acute Myeloid Leukemia and Newly Diagnosed, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
Silibinin is the major active component of silymarin, a commonly used hepatoprotective agent. It stabilizes hepatocyte membranes, preserves cellular integrity, and accelerates DNA synthesis in liver cells. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia, Newly Diagnosed, Chemotherapy Effect
- What is being tested?
- daunomycin/Idarubicin+ Silybinin and daunomycin/Idarubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed acute leukemia(non-M3)confirmed according to the 2018 WHO classification criteria for the diagnosis and classification of acute leukemia;
- Suitable for standard chemotherapy regimens containing idarubicin/daunorubicin;
- Patients with an expected survival time of at least 3 months as determined by the investigator;
- Voluntarily agree to participate in this study and sign the informed consent form.
Who cannot join
- History of other malignant tumors concurrently or previously diagnosed malignancies not under control;
- Participation in other clinical trials within one month prior to screening;
- Presence of uncontrolled cerebrovascular diseases, coagulation disorders, connective tissue diseases, or other such conditions;
- Other uncontrolled diseases that the investigator considers inappropriate for inclusion;
- Patients with psychiatric disorders or other known or suspected inability to fully comply with the study protocol;
- Pregnant or breastfeeding women;
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- History of liver cirrhosis, or current active liver disease or biliary disease;
- HIV-positive individuals;
- Any other conditions that, in the investigator's judgment, may prevent the subject from completing the study or pose significant risk to the subject.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Meijuan Huang, MD, 13365910912, huangmj@fjmu.edu.cn
About this study
Official title: Prospective Randomized Study of the Effectiveness and Safety of Chemotherapy Protocols Containing Daunorubicin /Idarubicin ± Silibinin in Treating Newly Diagnosed AML (Non-M3)
Silibinin is the major active component of silymarin, a commonly used hepatoprotective agent. It stabilizes hepatocyte membranes, preserves cellular integrity, and accelerates DNA synthesis in liver cells. Clinically, it is widely used in the treatment of chronic persistent hepatitis, chronic active hepatitis, early-stage liver cirrhosis, and hepatotoxicity. Moreover, it has been reported to inhibit the growth and differentiation of various cancer cells, including hepatocellular carcinoma, prostate cancer, breast cancer, and cervical cancer.
Based on these preclinical findings, we aim to evaluate the efficacy and safety of combining silybinin with the standard first-line idarubicin/daunorubicin-based regimen in the treatment of newly diagnosed acute leukemia(non-M3)in a clinical setting.
- Conditions
- Acute Myeloid Leukemia, Newly Diagnosed, Chemotherapy Effect
- Being tested
- daunomycin/Idarubicin+ Silybinin, daunomycin/Idarubicin
- Keywords
- AML, newly diagnosed, Silybin, daunorubicin, Idarubicin
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
daunomycin/Idarubicin+ SilybininDrug
The chmotherapy protocol includes daunomycin 60mg/m2/d or Idarubicin 10mg/m2/d for 3 days, at the same time, Silybin 200mg tid is administrated.
daunomycin/IdarubicinDrug
The chmotherapy protocol includes daunomycin 60mg/m2/d or Idarubicin 10mg/m2/d for 3 days
| Study group | Role | What they receive |
|---|---|---|
| daunomycin/ Idarubicin + Silybinin treatment | Experimental | The chmotherapy protocol includes daunomycin 60mg/m2/d or Idarubicin 10mg/m2/d for 3 days, at the same time, Silybin 200mg tid is administrated. Receives: Drug: daunomycin/Idarubicin+ Silybinin |
| daunomycin/Idarubicin treatment | Experimental | The chmotherapy protocol includes daunomycin 60mg/m2/d or Idarubicin 10mg/m2/d for 3 days Receives: Drug: daunomycin/Idarubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall remission rate (ORR)
subjects achieving complete remission (CR) or partial remission (PR) at the end of cycle 1and cycle 2(each cycle is 1 month)
Measured: At the end of Cycle 1 and Cycle 12 (each cycle is 1 month)
overall survival (OS)
subjects survival after treatment are finished
Measured: 1-year
Secondary outcomes (3)
Time to Response(TTR)
The time from initiation of the study treatment to the first documentation of CR or PR.
Measured: 1-2months(1-2 courses）
Duratin of Response(DOR)
The time from first documentation of CR to the first documented disease progression or death, whichever occurs first
Measured: 1-year
Progression-Free Survival(PFS)
The time interval from the start of the study treatment to the first documentation of disease progression or death from any cause,whichever occurs first
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Apr 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HuangMeiJuan, Fujian Medical University Union Hospital
- Investigators
- Yuanzhong Chen, MD, Study director, Fujian Institute of Haematology, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561892
- Sponsor's protocol ID
- FJ Depart of Hematology
- Acronym
- AML
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study of the Effectiveness and Safety of Chemotherapy Protocols Containing Daunorubicin /Idarubicin ± Silibinin in Treating Newly Diagnosed AML (Non-M3)
- ClinicalTrials.gov ID
- NCT07561892
- Acronym / sponsor ID
- AML / FJ Depart of Hematology
- Conditions
- Acute Myeloid Leukemia, Newly Diagnosed, Chemotherapy Effect
- Keywords
- AML, newly diagnosed, Silybin, daunorubicin, Idarubicin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Silibinin is the major active component of silymarin, a commonly used hepatoprotective agent. It stabilizes hepatocyte membranes, preserves cellular integrity, and accelerates DNA synthesis in liver cells. Clinically, it is widely used in the treatment of chronic persistent hepatitis, chronic active hepatitis, early-stage liver cirrhosis, and hepatotoxicity. Moreover, it has been reported to inhibit the growth and differentiation of various cancer cells, including hepatocellular carcinoma, prostate cancer, breast cancer, and cervical cancer.
Based on these preclinical findings, we aim to evaluate the efficacy and safety of combining silybinin with the standard first-line idarubicin/daunorubicin-based regimen in the treatment of newly diagnosed acute leukemia(non-M3)in a clinical setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| daunomycin/ Idarubicin + Silybinin treatment | Experimental | Drug: daunomycin/Idarubicin+ SilybininThe chmotherapy protocol includes daunomycin 60mg/m2/d or Idarubicin 10mg/m2/d for 3 days, at the same time, Silybin 200mg tid is administrated. |
| daunomycin/Idarubicin treatment | Experimental | Drug: daunomycin/IdarubicinThe chmotherapy protocol includes daunomycin 60mg/m2/d or Idarubicin 10mg/m2/d for 3 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Newly diagnosed acute leukemia(non-M3)confirmed according to the 2018 WHO classification criteria for the diagnosis and classification of acute leukemia;
- Suitable for standard chemotherapy regimens containing idarubicin/daunorubicin;
- Patients with an expected survival time of at least 3 months as determined by the investigator;
- Voluntarily agree to participate in this study and sign the informed consent form.
Key exclusion criteria (9 listed)
- History of other malignant tumors concurrently or previously diagnosed malignancies not under control;
- Participation in other clinical trials within one month prior to screening;
- Presence of uncontrolled cerebrovascular diseases, coagulation disorders, connective tissue diseases, or other such conditions;
- Other uncontrolled diseases that the investigator considers inappropriate for inclusion;
- Patients with psychiatric disorders or other known or suspected inability to fully comply with the study protocol;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| daunomycin/Idarubicin+ SilybininThe chmotherapy protocol includes daunomycin 60mg/m2/d or Idarubicin 10mg/m2/d for 3 days, at the same time, Silybin 200mg tid is administrated. | Drug | daunomycin/ Idarubicin + Silybinin treatment |
| daunomycin/IdarubicinThe chmotherapy protocol includes daunomycin 60mg/m2/d or Idarubicin 10mg/m2/d for 3 days | Drug | daunomycin/Idarubicin treatment |
Primary outcome
overall remission rate (ORR)
Time frame: At the end of Cycle 1 and Cycle 12 (each cycle is 1 month)
subjects achieving complete remission (CR) or partial remission (PR) at the end of cycle 1and cycle 2(each cycle is 1 month)
overall survival (OS)
Time frame: 1-year
subjects survival after treatment are finished
3 secondary outcomes
Time to Response(TTR)
Time frame: 1-2months(1-2 courses）
Duratin of Response(DOR)
Time frame: 1-year
Progression-Free Survival(PFS)
Time frame: 1-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuanzhong Chen, MD study director
Fujian Institute of Haematology, Fujian Medical University Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing daunomycin/Idarubicin+ Silybinin and daunomycin/Idarubicin in people with Acute Myeloid Leukemia and Newly Diagnosed, run by Fujian Medical University Union Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meijuan Huang (13365910912, huangmj@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall remission rate (ORR) (time frame: At the end of Cycle 1 and Cycle 12 (each cycle is 1 month)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.