Acute Myeloid Leukemia, Chemotherapy Effect, Newly Diagnosed
Conditions
Keywords
AML, newly diagnosed, Silybin, daunorubicin, Idarubicin
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.
Interventions
DRUGdaunomycin/Idarubicin+ Silybinin
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.
DRUGdaunomycin/Idarubicin
The chmotherapy protocol includes daunomycin 60mg/m2/d or Idarubicin 10mg/m2/d for 3 days
Sponsors
Fujian Medical University Union Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall remission rate (ORR) | 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) | 1-year | subjects survival after treatment are finished |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Response(TTR) | 1-2months(1-2 courses） | The time from initiation of the study treatment to the first documentation of CR or PR. |
| Duratin of Response(DOR) | 1-year | The time from first documentation of CR to the first documented disease progression or death, whichever occurs first |
| Progression-Free Survival(PFS) | 1-year | 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 |
Countries
China
Contacts
CONTACTMeijuan Huang
CONTACTShuxia Zhang, MD
STUDY_DIRECTORYuanzhong Chen, MD
Fujian Institute of Haematology, Fujian Medical University Union Hospital
Outcome results
None listed