hematological malignancies
Conditions
Interventions
Experimental group:CTX 40mg/kg/d and ATG 2.5-3.0mg /kg/d are given intravenously on day 3 and day 4 (+ 3d, +4d) after hematopoietic stem cell transfusion
Control group:Standard dose of ATG
Sponsors
He'nan Cancer Hospital /Affiliated Cancer Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
14 Years to 69 Years
Inclusion criteria
Inclusion criteria: 1. Aged 14-69 years, expected survival greater than 3 months; 2. Patients with hematologic malignancies assessed by the investigator as eligible for haploid hematopoietic stem cell transplantation; 3. ECOG score 0-2; 4. The patient's main tissues and organs function well: (1) Cardiac function: patients with no heart disease or coronary heart disease had grade I-II cardiac function; (2) Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5 times the upper limit of normal (ULN); (3) Bilirubin <=1.5 ULN (unless the increase in bilirubin is due to Gilbert' syndrome or non-hepatic origin); (4) Serum creatinine <= 1.5x ULN; (5) PT/INR<1.5 ULN and PTT (aPTT) <1.5 ULN; 5. No other serious diseases (such as autoimmune diseases, immune deficiencies) that conflict with this protocol; 6. No history of other malignant tumors; 7. Patients with reproductive potential must agree to use appropriate contraceptive methods (Hormonal or barrier methods; Abstinence); 8. The patient agreed to participate in the clinical study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Active autoimmune disease; 2. Patients who have undergone allogeneic hematopoietic stem cell transplantation within the last 5 years; 3. Patients with a history of human immunodeficiency virus (HIV) or progressive active hepatitis C virus (HCV) or hepatitis B virus (HBV) and positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg) must have a negative polymerase chain reaction (PCR) result prior to enrollment; patients with a positive PCR will be excluded; 4. Any uncontrolled active bacterial or fungal infection; 5. The patient is pregnant or breastfeeding; 6. Patients with progressive and clinically severe cardiovascular disease: for example, uncontrolled arrhythmias or grade 3 to 4 congestive heart failure as defined by the New York Heart Association functional classification, or patients with a history of myocardial infarction, unstable angina or acute coronary syndrome within 6 months prior to the screening period; 7. Patients who received any other investigational drug within the last 1 month; 8. In the judgment of the principal investigator, patients with serious complications or diseases may be placed at undue risk or interfere with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of grade II to IV acute GVHD; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of chronic GVHD;Time of granulocyte hematopoietic reconstruction and megakaryocyte hematopoietic reconstruction;Incidence of infections; | — |
Countries
China
Contacts
Public ContactZhou Jian
He'nan Cancer Hospital /Affiliated Cancer Hospital of Zhengzhou University
Outcome results
None listed