acute graft-versus-host disease
Conditions
Interventions
Group 1:Post-transplantation Cyclophosphamide (PTCy)
Group 2:Anti-thymocyte Globulin
Sponsors
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. The subject must be diagnosed as acute myeloid leukemia and proposed to undergo haploidentical allogeneic hematopoietic stem cell transplantation. The pre-transplant disease status of the subject should be first complete remission (AML-CR1) and negative minimal residual disease. 2. The donors and recipients of hematopoietic stem cell transplantation should be both male. The age of the donors should be = 20 years old and = 30 years old. The age of the recipients should be = 45 years old and = 60 years old. 3. The subject should be negative for donor specific antibody (DSA). 4. The HLA matching of the donor and recipient should be 6~7/12. 5. The predicted life span of the subject must be at least 12 weeks. 6. The physical state score (eastern cancer cooperation group, ECOG) of the subject must be 0-2. 7. The subjects should have no active infection. 8. The subjects should meet the laboratory test criteria as follows: normal renal function (BUN, Cr = 1.25-fold the upper limit of normal value, creatinine clearance rate > 50 ml / min); normal liver function (ALT and AST = 3-fold the upper limit of normal; total bilirubin = 2-fold the upper limit of normal); ECG examination without acute myocardial infarction, arrhythmia or atrioventricular block (more than grade I); no cardiac insufficiency (left ventricular ejection fraction = 50%); no active rheumatic heart disease; No cardiac enlargement by chest X-ray or physical examination; normal lung function (defined as FEV1, FVC, DLCO = 60% of predictive value). 9. The subjects should be voluntary to be enrolled in the study, sign consent and be in compliance with the study.
Exclusion criteria
Exclusion criteria: 1. Subjects have received the following treatments: (1) Hematopoietic stem cell transplantation (including autologous and allogeneic transplantation) treatment; (2) CAR-T cell therapy; (3) Previous chest/mediastinal radiotherapy; 2. Meet one of the following conditions: (1) It is known that the subject is an active tuberculosis patient or HIV seropositive; (2) Known seropositive for hepatitis B surface antibody, positive for any other antibody/antigen of hepatitis B or known or suspected active hepatitis C infection; (3) The subject is known to be EBV-DNA or CMV-DNA seropositive; (4) The subject is known to be EBV-IgG or CMV-IgG seronegative; (5) Allergies to drugs (especially ATG and antiemetic drugs) used during transplantation; (6) Severe damage to important organ functions: such as respiratory failure, heart failure, decompensated liver insufficiency, renal insufficiency, etc.; (7) The subject has evidence of uncontrolled systemic infection (virus, bacteria or fungus) that requires treatment; (8) The subject has a history of other malignant tumors within 2 years before entering the study; 3. People with mental disabilities/people who cannot obtain informed consent; 4. Patients who take drugs or drink alcohol for a long time so as to affect the evaluation of test results; 5. Those who are judged by the investigator to be unsuitable to participate in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| single cell RNA transcriptome;T cell receptor repertoire; | — |
Secondary
| Measure | Time frame |
|---|---|
| lymphocyte subpopulation;T cell metabolism;GvHD biomarker; | — |
Countries
China
Contacts
Public ContactXiaoxia Hu
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed