MDS/CMML/AML
Conditions
Interventions
Experimental group:Prophylactic administration of low-dose Azacitidine after allogeneic stem-cell transplantation
Sponsors
Blood Diseases hospital, Institute of Hematology, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
15 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. It meets the diagnostic criteria of WHO classification MDS and has one of the following characteristics. (1) Mds-eb2 diagnosis was confirmed; (2) Karyotype with poor prognosis; (3) Ipss-r score was very high risk; (4) TP53 mutation was positive. 2. High risk of relapse AML, including relapsed refractory AML and patients with MRD positive AML before transplantation, (1) Refractory AML is one of the following conditions. After two courses of chemotherapy, the first treatment cases were ineffective; After Cr, the recurrence occurred within 12 months after consolidation and intensive treatment; The recurrence was 12 months later, but conventional chemotherapy was ineffective; 2 or more recurrences; Extramedullary leukemia persisted. (2) Relapsed AML means that leukemia cells reappear in peripheral blood after complete remission (CR), or bone marrow primitive cells > 0.050 (except for other reasons such as bone marrow reconstruction after consolidation chemotherapy) or extramedullary leukemia cell infiltration. (3) If MRD was positive before transplantation, one of the following conditions was met. The proportion of abnormal myeloid cells detected by flow cytometry before transplantation was more than 0.01% The results of molecular biology were positive before transplantation; 3. Patients who met the diagnostic criteria of WHO classification of CMML; 4. Patients receiving allogeneic hematopoietic stem cell transplantation (including HLA matched or mismatched allogeneic hematopoietic stem cell transplantation and unrelated donor transplantation). 5. Patients with age >= 15 years old and < 65 years old are not limited to men and women. 6. Patients with ECOG-ps score of 0-2 in Eastern oncology collaboration group. 7. For patients who have to sign the informed consent form before the start of the research procedure, the informed consent form shall be signed by the patient himself or his immediate family member for patients aged 18 and above; the informed consent form shall be signed by the legal guardian for children and adolescents under the age of 18.
Exclusion criteria
Exclusion criteria: 1. Patients with recurrence within 2 months after transplantation or during maintenance treatment, including hematology, molecular genetics and cytogenetics; 2. Patients who have a history of cancer and have received any treatment for this tumor in the past 3 years, but have removed superficial bladder cancer, basal cell or squamous cell carcinoma of skin, cervical intraepithelial carcinoma (CIN) or prostate intraepithelial carcinoma (PIN); 3. Patients who have known positive serological reaction of HIV or active hepatitis C virus; 4. Suffering from mental disorders or other conditions and unable to meet the requirements of research, treatment and monitoring; 5. Pregnant patients or patients who can not take appropriate contraceptive measures during treatment; 6. Patients who are known to be allergic to any component of azacytidine; 7. Patients with active heart disease are defined as one or more of the following: (1) There was a history of uncontrolled or symptomatic angina pectoris; (2) Myocardial infarction less than 6 months after the study; (3) There is a history of arrhythmia requiring drug treatment or severe clinical symptoms; (4) Uncontrolled or symptomatic congestive heart failure (> NYHA grade 2); (5) Ejection fraction was lower than the lower limit of normal range. 8. Patients considered unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| relapse free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse rate;Overall survival;Transplant-related mortality;Graft-versus-host disease;Patient's tolerance; | — |
Countries
China
Contacts
Public ContactYigen Cao
Blood Diseases Hospital, Institute of Hematology, Chinese Academy of Medical Sciences
Outcome results
None listed