Myelodysplastic Syndromes
Conditions
Interventions
Group A:Xinlikang Low Dose Group:Xinlikang capsules, 5 capsules tid, orally after meals, for 12 weeks.
Group B:Xinlikang Medium Dose Group:Xinlikang capsules, 8 capsules tid, orally after meals, for 12 weeks.
Group C:Xinlikang High Dose Group:Xinlikang capsules, 10 capsules tid, orally after meals, for 12 weeks.
Sponsors
The First Affiliated Hospital Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age =18 years; male or non-pregnant, non-lactating female; 2.Voluntarily sign an informed consent form before any study-related assessment/procedure; 3.Diagnosed with primary myelodysplastic syndrome, classified as very low risk, low risk, or intermediate risk (=3.5 points) according to IPSS-R, and with bone marrow blast cells <5% (recorded within 16 weeks prior to treatment); 4.Hemoglobin =6 g/dL and <10 g/dL during the screening period (average of the two most recent hemoglobin measurements, more than 3 days apart, and without red blood cell transfusion within 14 days); 5.Red blood cell transfusion =2 units within 16 weeks prior to enrollment; 6.Platelet count =50×10^9/L, neutrophil count =0.8×10^9/L; 7.ECOG score of 0-2; 8.Subjects willing to accept monotherapy with traditional Chinese medicine; 9.Subjects with reproductive potential and their male partners must agree to use effective contraception during the trial period and for at least 3 months after the last administration of the study drug; 10.Normal liver and kidney function (creatinine ?1.5ULN, BUN ?1.5ULN, ALT ?3ULN, AST ?3ULN, total bilirubin ?2.0*ULN); 11.Able to comply with the study visit schedule and understand and follow all study protocol requirements.
Exclusion criteria
Exclusion criteria: 1.Subjects with myelodysplastic syndrome accompanied by isolated 5q- (5q- syndrome), chromosome 7 abnormalities, biTP53, t(3;3), and complex karyotype; 2.Life expectancy <6 months; 3.Subjects who have previously received allogeneic or autologous stem cell transplantation. 4.Subjects with a known history of AML diagnosis; 5.Active infections requiring intravenous antibiotic treatment and any active malignancies; 6.Participants in other clinical trials within the last 30 days; 7.Subjects currently on immunosuppressive therapy, androgens, or other traditional Chinese medicines that cannot be discontinued. 8.Received ESA, androgens, immunosuppressive therapy (antithymocyte globulin, cyclosporine A), azacitidine, decitabine, Luspatercept, roxadustat, traditional Chinese medicine, immunomodulatory drugs (thalidomide, lenalidomide), intravenous or oral arsenic, retinoic acid, and other cytotoxic drugs within 4 weeks prior to treatment; 9.Known clinical significant iron deficiency anemia, megaloblastic anemia, autoimmune hemolytic anemia, thalassemia, or other hemolytic anemias, active gastrointestinal bleeding, etc.; 10.Subjects with mental disorders or other conditions that cannot cooperate with the requirements of the study treatment and monitoring; 11.Other conditions deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase II recommended dose;Dose-limiting toxicity (DLT);Maximum Tolerated Dose (MTD); | — |
Secondary
| Measure | Time frame |
|---|---|
| FACT-An;EROCT-QLQ C30;Hemoglobin;Peripheral Blood Lymphocyte Subsets;Peripheral Blood Cytokines; | — |
Countries
China
Contacts
Public ContactHongyan Tong
The First Affiliated Hospital Zhejiang University School of Medicine
Outcome results
None listed