The clinical study of PD-1 inhibitor Tislelizumab combined with HMA and cytarabine in the treatment of high-risk myelodysplastic syndromes
Conditions
Interventions
Group 1:Tislelizumab combined with HMA and cytarabine in the treatment of medium to high-risk myelodysplastic syndromes
enrolled patients received at least two courses of treatment to evaluate the effectiveness and safety.
Sponsors
Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technol
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant non-lactating female patients, aged >=18 years; 2. According to the 2016 WHO diagnostic criteria (Annex 1) and IPSS-R prognostic score (Annex 2), MDS patients with medium to high risk (IPSS-R prognostic score>3.5) diagnosed by bone marrow aspiration or biopsy; 3. According to the Eastern United States Oncology Group's physical status score (ECOG PS, Appendix 3), it is 0~2 points; 4. Not suitable or refuse to receive intensive chemotherapy and allogeneic hematopoietic stem cell transplantation (due to factors such as age, comorbidities, lack of suitable donors, etc.); 5. Newly diagnosed MDS patients who have not received past methylation therapy or chemotherapy (allowing blood transfusion, hematopoietic growth factor and supplementary hematopoietic raw material treatment); 6. Has sufficient organ function, defined as follows: 1) Liver function: serum total bilirubin (TBIL) 30g/L. Subjects with Gilbert syndrome require TBIL= 50 ml/min (calculated with CKD-EPI formula). 3) Coagulation function: International normalized ratio (INR) = 12 weeks; 8. Female subjects of childbearing age or male subjects whose partners are women of childbearing age must take effective contraceptive measures throughout the treatment period and 6 months after the treatment period; 9. Able to tolerate bone marrow aspiration and biopsy during the screening period and detection time point; 10. Sign a written informed consent and be able to comply with the visit and related procedures stipulated in the plan.
Exclusion criteria
Exclusion criteria: Exclusion criteria (One): 1. Patients with MDS transformed into AML are defined as the original and immature cells in the bone marrow smear >= 20%, or the presence of AML characteristic clonal changes such as t(15;17), t(8;21), t(16 ;16), inv(16); 2. Treatment related MDS (t-MDS), myeloproliferative neoplasms (Myeloproliferative Neoplasms, MPN) transformed MDS; 3. MDS/MPN (myelodysplastic syndrome/myeloproliferative disease) including chronic myelomonocytic leukemia; 4. MDS patients with IPSS-R=160 mmHg or diastolic blood pressure >= 100 mmHg) that is still uncontrolled even with standard treatment; (5)Any arterial thromboembolic events, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack occurred within 6 months before being selected for treatment; (6)Esophageal or gastric varices that require immediate in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone marrow cytology; | — |
Countries
China
Contacts
Public ContactHong Mei
Union Hospital, Tongji Medical College of HUST
Outcome results
None listed