Newly diagnosed patients confirmed as myelodysplastic syndrome (MDS) with IB-1 or IB-2 according to the WHO-2022 classification
Conditions
Sponsors
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; expected survival time >= 3 months; 2. ECOG score 0-2; 3. Women of childbearing potential must have a negative pregnancy test and be willing to use effective contraception during the study period and for >=12 months after the last dose. Male participants must use effective contraception during the study period and for >=3 months after the last dose. 4. Intact hepatic and renal function (creatinine <= 1.5 × ULN, BUN <= 1.5 × ULN, ALT <= 2 × ULN, AST <= 2 × ULN, total bilirubin <= 1.5 × ULN). 5. Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with a planned hematopoietic stem cell transplantation. 2. Patients with a history of malignancy who have received any treatment for that malignancy within the past 3 years, except for: superficial bladder cancer, basal cell or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia (CIN), ductal carcinoma in situ of the breast, or prostatic intraepithelial neoplasia (PIN); or other localized malignancies treated with surgical excision or radiotherapy with a high probability of cure. 3. Presence of active viral or bacterial infection not adequately controlled by appropriate antimicrobial therapy. 4. Positive serology for HIV. 5. Presence of psychiatric disorders or other conditions that preclude compliance with the requirements of study treatment and monitoring. 6. Patients with uncontrolled cardiac disease. 7. History of or presence of dry tap on bone marrow aspiration. 8. Resence of bone marrow fibrosis of grade 2 or 3. 9. Other conditions that, in the investigator's judgment, make the subject unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response (CR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);Hepatic and Renal Function;Treatment-Related Infection;Duration of Response (DOR);Myelosuppression;Overall Survival (OS);Cytogenetic Response;Partial Response (PR);Complete Remission with Partial Hematologic Recovery (CRh);Gastrointestinal Toxicity;Complete Remission with Limited Count Recovery;Hematologic Improvement (HI);Overall Response Rate (ORR); | — |
Countries
China
Contacts
Public ContactHongyan Tong
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed