NCT07561892 Study of the Effectiveness and Safety of Daunorubicin /Idarubicin ± Silibinin in Treating Newly Diagnosed AML (Non-M3).
| NCT ID | NCT07561892 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Fujian Medical University Union Hospital |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-04-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2022-04-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
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.
Contact & Investigator
Yuanzhong Chen, MD
STUDY DIRECTOR
Fujian Institute of Haematology, Fujian Medical University Union Hospital
Frequently Asked Questions
Who can join the NCT07561892 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07561892 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07561892 currently recruiting?
Yes, NCT07561892 is actively recruiting participants. Contact the research team at huangmj@fjmu.edu.cn for enrollment information.
Where is the NCT07561892 trial being conducted?
This trial is being conducted at Fuzhou, China.
Who is sponsoring the NCT07561892 clinical trial?
NCT07561892 is sponsored by Fujian Medical University Union Hospital. The principal investigator is Yuanzhong Chen, MD at Fujian Institute of Haematology, Fujian Medical University Union Hospital. The trial plans to enroll 100 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.