MDS/CMML
Conditions
Interventions
Experimental group:BuCy-FDI
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: Participants in this study must meet all of the following criteria: 1. MDS/CMML patients with a relatively high risk group of bone marrow cell morphology, immunology and genetic diagnosis were diagnosed with the world health organization diagnostic criteria (WHO2008 standard); 2. Meet the critical, high-risk and extremely high risk criteria of Ipss-R hazard classification; 3. Recipient of allogenetic-hematopoietic stem cell transplantation (including HLA matched or incomplete matched allogenetic-hematopoietic stem cell transplantation and unrelated donor transplantation); 4. Aged 15 to 65 years old male and female; 5. The eastern oncology collaborative group physical status assessment (ECOG-PS) was 0-2 points; 6. Prior to the commencement of the research procedure, the informed consent shall be signed. The person of 18 years and above shall sign the informed consent form by the patient himself or the immediate family; The legal guardian shall sign the informed consent form for children under 18 years of age.From the patient's condition, if the patient's signature is not conducive to the treatment, the legal guardian or the immediate family of the patient shall sign the informed consent form.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria shall not be included in this study: 1. The history of the tumor and accept any in the past three years for the treatment of the tumor, but remove the base layer of superficial bladder cancer, skin cell or squamous cell carcinoma, cervical intraepithelial cancerous (CIN) or prostate intraepithelial (PIN); 2. The serological reaction of known HIV or active hepatitis c virus is positive; 3. Suffering from mental disorders or other conditions that cannot be coordinated with research and treatment and monitoring requirements; 4. Patients who are pregnant or are not able to take appropriate contraceptives during treatment; 5. They are known to be allergic to any of the ingredients in decitabine; 6. Have received hematopoietic stem cell transplantation in the past 1 years; 7. Active heart disease is defined as one or more of the following: 1) history of uncontrolled or symptomatic angina; 2) myocardial infarction with less than 6 months of study time; 3) history of arrhythmias requiring drug treatment or severe clinical symptoms; 4) uncontrolled or symptomatic congestive heart failure (> NYHA 2grade); 5) the ejection fraction is lower than the normal range; 8. The researchers did not think fit into the group.
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 ContactYigeng cao
Blood Diseases hospital, Institute of Hematology, Chinese Academy of Medical Sciences
Outcome results
None listed