higher-risk Myelodysplastic syndrome
Conditions
Interventions
Group A:Sintilimab+Decitabine
Sponsors
Peking University, People's Hospital, Peking University Institute of Hematology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed patients with higher-risk myelodysplastic syndrome; 2. The researchers determined that there were indications of treatment with decitabine; 3. aged >=18 years old; 4. Have no renal or hepatic dysfunction (serum creatinine level = 50%); 5. There are no uncontrollable active infections or serious infectious diseases, ECOG performance status of 2 or less; 6. The researchers judged that it was not suitable for intensive therapy; 7. The researchers determined that hematopoietic stem cell transplantation was not suitable; 8. Written informed consent was obtained from all patients.
Exclusion criteria
Exclusion criteria: 1. Patients must not have had prior exposure to any immune checkpoint inhibitors including anti-PD-L1 gents, anti-PD-L2 agents, or anti-CTLA-4 monoclonal antibodies; 2. Patient has previously received first-line treatment with any drug for high-risk MDS; 3. Patients must not have received any other form of immunosuppressive therapy within 4 weeks prior to the first dose of the study; 4. Patients must not have received live attenuated vaccines within 4 weeks prior to the first dose (or plan to receive live attenuated vaccines during the study period); 5. Patients with known immunodeficiency are ineligible; 6. Patients must not have had prior allogeneic stem cell transplantation or allogeneic organ transplantation; 7. Patients must not be pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical improvement rate;Complete response rate;Overall survival;Disease free survival;Event-free survival;Adverse Events; | — |
Countries
China
Contacts
Public ContactWang Jing
Peking University, People's Hospital, Peking University Institute of Hematology
Outcome results
None listed