myelodysplastic syndromes
Conditions
Interventions
Group 1:Carelizumab and Decitabine
Group 2:Decitabine
Sponsors
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1)According to the diagnostic criteria of MDS (2008), the IPSS (international prognostic score) was classified as intermediate-2 risk, high-risk and refractory MDS patients; 2) Age between 18 and 80 years; 3) No differentiation inducing drugs were used within the first three months of inclusion, such as all-transretinoic acid, valproic acid and arsenic trioxide in the past three months; 4) ECOG score 0-2; 5) Creatinine <= 1.5 fold ULN, BUN <= 1.5 fold ULN, ALT <= 2 fold ULN, AST <= 2 fold ULN, Tbil <= 1.5 fold ULN (ULN means the upper limit of the normal range); 6) Patients were treated by cell stimulating factor therapy in the past, Stop using cell stimulating factor therapy at least a month before joining the study; 7) Accurate past history and treatment history (including blood transfusion, and hemoglobin measure) in the past 8 weeks before joining the study; 8) The patient or family members understand and voluntarily signed informed consent.
Exclusion criteria
Exclusion criteria: 1) In recent 30 days, patients received other study drug therapy; 2) 5q-syndromes 3) Patients with a history of tumor and received treatment for tumor in the past three years, in addition to the base layer of superficial bladder cancer, skin cell or squamous cell carcinoma, cervical intraepithelial cancerous (CIN) or prostate intraepithelial (PIN). 4) Patients have active viral or bacterial infections, and failure to use appropriate anti-infection treatment; 5) Patients with mental disorders or other condition and cannot cooperate research treatment and monitoring requirements; 6) Pregnancy (Women of childbearing age need to undergo pregnancy tests) and lactation. 7) HIV positive and active hepatitis patients are excluded in this study; 8) Researchers think unfavorable patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| bone marrow complete response rate (mCR);cytogenetic response rate;blood transfusion needs;safety and quality of life; | — |
Countries
China
Contacts
Public ContactZhang Zheng
Shanghai Jiaotong University Affiliated Sixth People's Hospital
Outcome results
None listed