Objectives of Study:
|
Primary Objective: To evaluate the efficacy and safety of multiple doses and multiple administrations of Xinlikang capsules in subjects with lower-risk myelodysplastic syndromes, and to determine the Recommended Phase 2 Dose (RP2D) for further studies.
Secondary Objectives: To assess the improvement in immune indicators in the peripheral blood, quality of life, and fatigue in subjects.
|
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:
|
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.
|