Acute myeloid leukemia and Myelodysplastic syndromes
Conditions
Interventions
experimental group:Microtransplantation plus chemotherapy
Control Group:Chemotherapy
Sponsors
Bone Marrow Transplantation Center of the First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Aged 18-75 years old male and female; 2. It was confirmed as AML-MRC according to the 2016 WHO diagnostic criteria and according to the 2016 MDS-IPSSR risk stratification of NCCN, AML in the elderly aged over 60, and MDS over medium-risk II (including medium-risk II); 3. No anti-acute leukemia treatment has been received in the past (including demethylated drugs for leukemia or MDS, except hydroxyl urea and leukocyte monocytosis); 4. The physical strength of ECOG was less than or equal to 2; 5. Unsuitable or unwilling to undergo allogeneic hematopoietic stem cell transplantation; 6. Patients with AML are willing to use desitabine at their own expense and have no history of allergy to desitabine 7. The subject must have a donor (A, B, C, DRB1, DQ) compatible with the HLA genotype 0-7/10 site (A, B, C, DRB1, DQ), and the donor voluntarily donated the hematopoietic stem cells and signed the consent form; 8. Biochemical indicators must be within the following limits: ALT and AST are less than or equal to 3 times the upper limit of normal value (ULN); Total bilirubin less than or equal to 3 times ULN; Serum creatinine is less than or equal to 2 times ULN or CrCl is greater than or equal to 40mL/min; 9. The LVEF measured by echocardiography was within the normal range (LVEF>50%); 10. Each subject (or his legal representative) must sign an informed consent form (ICF) stating that he or she understands the purpose and procedures of the study and is willing to participate in the study; Supplier selection criteria: 1. Age less than or equal to 40 years old, male is preferred; 2. It is necessary to have a direct or collateral relationship with the patient within three generations or to be the spouse of the patient; 3. Matched with recipient HLA genotype 0-7/10 loci (A, B, C, DRB1, DQ); 4. The examination project of microtransplantation donor is qualified; 5. Able to tolerate the separation and collection of blood cells; 6. Sign the consent form.
Exclusion criteria
Exclusion criteria: Patient exclusion criteria: 1. Other malignant tumors diagnosed as requiring treatment within or within the last 1 year other than AML or under treatment; 2. Acute promyelocytic leukemia, myeloid sarcoma, chronic myeloid leukemia acceleration and acute transformation; 3. Patients with severe liver and kidney function and cardiopulmonary insufficiency; 4. Uncontrolled or severe infection; 5. Mental illness that may hinder the completion of treatment or informed consent of the subject; 6. The donor does not meet the requirements: HIV positive, hepatitis b or c, bone marrow disorders. Exit criteria: 1. Subject's own intention; 2. Subjects who violate the study plan and influence the evaluation; 3. No CR or CRi was found after two courses of chemotherapy; 4. The researchers believe that patients' conditions change due to side effects or other toxicity, and that continuing the study will do more harm than good.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remisson;1 year's overall survival;2 year's OS;partial remission;total response rate;relapse rate;therapy related motality;early mortality;blood cell recover time;transfusion related reaction;GVHD occurance rate; | — |
Countries
China
Contacts
Public ContactJie Sun
Bone Marrow Transplantation Center of the First Affiliated Hospital,College of Medicine,Zhejiang University
Outcome results
None listed