Low-risk myelodysplastic syndrome with anemia
Conditions
Interventions
Test group:The starting dose for the first 6 subjects was set at 50 mg BID. After the 2-week (14-day) DLT observation period, the dose could be adjusted to 150 mg QD or 100 mg BID based on tolerabilit
Sponsors
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18, regardless of gender; 2. Confirmed diagnosis of MDS according to WHO 2016 classification; 3. Patients with myelodysplastic syndromes classified as low-risk group based on the International Prognostic Scoring System-Revised (IPSS-R): very low-risk, low-risk, and intermediate-risk groups (= 0.5 × 10^9/L; 11. Platelet count >= 30 × 10^9/L; 12. Patients who have not received JAK inhibitor treatment before; 13. 14 days before enrollment, the main organ functions were normal, which met the following criteria: Main organ functions were normal, which met the following criteria: ALT and AST = 45 mL/min; 14. In accordance with the requirements of the ethics committee, voluntarily sign the informed consent form; 15. Able to comply with the research and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Having MDS associated with the del(5q) chromosomal abnormality; 2. History of organ transplantation or history of allogeneic hematopoietic stem cell transplantation; 3. Any significant clinical and laboratory abnormalities that the researchers consider to affect the safety assessment, such as: a. Uncontrollable diabetes (>250 mg/dL or >13.9 mmol/L), b. Hypertension and being unable to be reduced to the following ranges through combined antihypertensive treatment (systolic blood pressure < 160 mmHg, diastolic blood pressure < 100 mmHg), c. Peripheral neuropathy (Grade 2 or above according to NCI-CTC AE v5.0 criteria). 4. Patients with a history of congestive heart failure (Grade 3 or above according to the 5th edition of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE V5.0)), uncontrolled or unstable angina pectoris or myocardial infarction, cerebrovascular accident events or pulmonary embolism within the previous 24 weeks will be excluded. 5. Select patients who underwent surgical procedures within the past 4 weeks and have not yet fully recovered. 6. During the screening process, patients with arrhythmia disorders that require treatment (except for digoxin) should be excluded. 7. Any individuals with active bacterial, viral, parasitic or fungal infections that require treatment during the screening process; 8. Those who tested positive for HIV during screening, had positive results for active hepatitis B virus (HBsAg positive and HBV-DNA positive or above the normal reference range), had anti-HCV antibodies and positive HCV-RNA. 9. Patients with epilepsy or those using psychotropic drugs or sedatives (except for estazolam tablets) will be excluded during the screening process; 10. Female patients planning to conceive, who are already pregnant, or those in the lactation period; male patients who do not use condoms during the drug administration period and for 2 days (approximately 5 half-lives) after the last dose. 11. When combined with other serious diseases, the researchers believe that it may affect the safety or compliance of the patients; 12. Those suspected of being allergic to gicipritin hydrochloride or similar drugs; 13. Any patient who the researcher deems unsuitable to participate in this clinical study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in hemoglobin/serum iron/serum erythropoietin/ferritin during treatment;Maximal Tolerated Dose(MTD); | — |
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse reactions;Proportion of subjects with red blood cell response (HI-E); | — |
Countries
China
Contacts
Public ContactHongyan Tong
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed