IPSS-R lower risk myelodysplastic syndrome (MDS) anemia
Conditions
Interventions
Intervention group:AND017 capsules, dosage specifications: 2mg, 4 mg and 10 mg, frequency: 12mg/time, three times a week (TIW), participants will not be remedied for missed doses. If the participant v
Sponsors
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female aged >=18 years at the time of signing the informed consent form; 2. Diagnosed with MDS, and the IPSS-R classification is classified as very low, low or intermediate risk (=8U and red blood cell transfusion within 8 weeks >=4U; 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) is 0~1 (those with a score of 2 can be included if it is caused by anemia caused by MDS); 6. Female participants of childbearing potential are willing to take appropriate contraceptive measures from signing informed consent to 6 months after the last dose and should not breastfeed; Male participants are willing to use barrier contraception (i.e., condoms) from the time of signing informed consent until 6 months after the last dose. 7. Female participants have a negative blood pregnancy test within 7 days prior to the first dose, or meet one of the following criteria to prove that there is no risk of pregnancy: (1) Age >=60 years old and amenorrhea for at least 12 months after stopping all exogenous hormone replacement therapy; (2) Age<60 years old amenorrhea for at least 12 months after stopping all exogenous hormone therapy, and luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within the laboratory postmenopausal reference values; (3) Have undergone irreversible sterilization surgery, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, except for bilateral tubal ligation. 8. Volunteer to participate in this clinical trial, understand the study procedures and be able to sign the informed consent form in writing.
Exclusion criteria
Exclusion criteria: 1. Has a deletion of chromosome 5q, i.e., del(5q); 2. Anemia caused by other causes, such as iron deficiency anemia, megaloblastic anemia, aplastic anemia, renal anemia or blood loss, etc.; 3. Serious infection within 4 weeks before the first dose of study drug, including but not limited to infectious complications, bacteremia, severe pneumonitis, etc. that lasted =for 2 weeks of intravenous antibiotic administration; Persistent active or uncontrolled infection such as persistent fever or other symptoms of infection prior to the first dose of study drug administration. Participants who are receiving or have received prophylactic antibiotic therapy (such as prevention of urinary tract infections) may be enrolled; 4. Heart failure assessed by the New York College of Cardiology (NYHA) grade 3 or 4 during the screening period; 5. History of drug or alcohol abuse within the past 2 years (as judged by the investigator; 6. History of new or progressive cerebral infarction (except lacunar cerebral infarction), pulmonary embolism, deep vein thrombosis (DVT), or arterial embolism within 6 months before the first dose of study drug; 7. Have serious, uncontrolled, or active cardiovascular and cerebrovascular disease, including but not limited to: (1) Acute myocardial infarction within 6 months before the first dose of study drug administration; (2) Unstable angina within 6 months prior to the first dose of study drug administration; (3) Cerebrovascular accident or transient ischemic attack within 6 months before the first dose of study drug administration; (4) History of arrhythmias with significant clinical significance (as judged by the investigator); or any symptomatic or clinically significant cardiac arrhythmia occurred during the screening period. 8. Presence of any of the following cardiac test criteria: (1) Mean Fridericia-corrected QT interval (QTcF) > 470 msec obtained by electrocardiogram (ECG) examination at rest; (2) Resting ECG suggests any clinically significant rhythm, conduction, or ECG morphological abnormalities judged by the investigator (such as complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, and PR interval > 250 msec, etc.); (3) Presence of any factors that increase the risk of QTc prolongation or arrhythmic events, such as heart failure, refractory hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death or prolonged QT interval in immediate family members under 40 years of age, or any concomitant drugs that prolong the QT interval; (4) Left ventricular ejection fraction (LVEF) ). =2×10^3 IU/mL, if the retest drops to less than 2×10^3 IU/mL after regular antiviral therapy) or hepatitis C (defined as positive test result of hepatitis C virus antibody [HCV-Ab] and positive HCV-RNA during the screening period), syphilis (Treponema pallidum-specific antibody and non-specific antibody are both positive) or human immunodeficiency virus HIV infection (anti-HIV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin level and other related indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| IPSS-R score;EPO baseline level;hemoglobin baseline value; | — |
Countries
China
Contacts
Public ContactZhijian Xiao
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed