Myeloid malignancies
Conditions
Interventions
A:Decitabine 20mg/m2 for 5 days
B:Decitabine 20mg/m2 for 5 days, and PD-1 inhibitor 3mg/kg on the sixth day
Sponsors
The Second Hospital of Tianjin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years; 2. High-risk and refractory patients with myeloid tumor; 3. Bone marrow primitive cells >=5%; 4. Adequate organ function: creatinine <= 2.0 x ULN (upper limit of normal value);Serum bilirubin <=2.0 x ULN; AST and ALT <=2.0 x ULN; 5. ECOG score <= 2; 6. Women of reproductive age must have negative serum pregnancy test at the time of screening or before the first dose of medication, during the whole study period and 28 days after the end or termination of the study, the patients should adopt approved effective contraceptive methods; According to the researchers, a patient's fertility means that he or she is biologically capable of having children and having a normal sex life. Female patients without fertility (i.e., meeting at least one of the following criteria) : 1) hysterectomy or bilateral ovariectomy has been performed; 2) ovarian failure is medically confirmed as postmenopausal (at least 12 consecutive months of menopause without pathological or physiological causes); 7. Fertile men must use effective contraceptive methods throughout the study period and within 4 weeks after administration; 8. Patients or their legally authorized representatives must provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. History of malignant tumor or hematopoietic stem cell transplantation; 2. The first 2 weeks before any major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy and experimental treatmentSecondary use of drugs in this study; 3. Autoimmune disease history; 4. Patients with known positive hepatitis b surface antigen expression or hepatitis c infection (positive polymerase chain reaction or antiviral treatment for hepatitis c within the past 6 months) and a history of HIV; 5. Patients with other known serious and/or uncontrolled diseases (e.g., uncontrolled diabetes; Cardiovascular diseases include congestive heart failure, NYHA grade III or IV, myocardial infarction within 6 months, and poorly controlled hypertension.Chronic renal failure;Or an active uncontrolled infection), which, in the researchers' view, may affect participation in the study; 6. Pregnant and lactating women; 7. Screening or a history of alcohol/drug abuse within 12 months before the first dose; 8. Patients with poor compliance; 9. Unwilling to use effective contraception during the trial; 10. The attending researcher believes that there is any other situation that may cause the subject to fail to complete the study or bring obvious risks to the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response, CR;?????(hematologic improvement, HI; | — |
Countries
China
Contacts
Public ContactBai Jie
The Second Hospital of Tianjin Medical University
Outcome results
None listed