hematological malignancies
Conditions
Interventions
Group 1:Reduced PTCy combined with low dose ATG
Group 2:Standard dose PTCy plus ATG
Sponsors
Cancer Hospital Affiliated to Zhengzhou University-He'nan Cancer Hospital
Eligibility
Sex/Gender
All
Age
12 Years to 69 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 12 years, 3 months; 2. Subjects were assessed by the investigator to be eligible for an unrelated donor transplant with hematologic malignancy; 3. ECOG score 0-2; 4. The main tissues and organs of the patient have good functions: (1) Cardiac function: no heart disease or coronary heart disease, heart function 1-2; (2) Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 times the normal upper limit (ULN); (3) Bilirubin <= 1.5 times ULN (unless elevated bilirubin is due to Gilbert's syndrome or a non-hepatic source); (4) Serum creatinine <= 1.5 times ULN; (5) PT/INR < 1.5 times ULN and PTT (aPTT) < 1.5 times ULN; 5. No other serious diseases (such as autoimmune diseases, immune deficiency) that conflict with the program; 6. No history of other malignant tumors; 7. Women and men with reproductive potential must agree to appropriate use before entering the study and during study participation (hormonal or barrier contraceptive methods; abstinence); 8. The patient agreed to participate in the clinical study and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have received allogeneic hematopoietic stem cell transplantation in the last 5 years; 2. Patients who had received small molecular targeted inhibitor therapy within 2 weeks before enrollment; 3. Patients with a history of human immunodeficiency virus (HIV) or hepatitis C virus (HCV) or hepatitis B virus (HBV) are sexually active. Patients with positive hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg) must have negative results of polymerase chain reaction (PCR) before entering the group, and patients with positive PCR will be excluded; 4. Any uncontrolled active bacterial or fungal infection; 5. The patient is pregnant or lactating; 6. Patients with progressive and clinically severe cardiovascular disease, such as uncontrolled arrhythmias or grade 3-4 congestive heart failure as defined by the New York Heart Association Functional classification, or a history of myocardial infarction, unstable angina, or acute coronary syndrome in the 6 months prior to the screening period; 7. Patients who received any other research drugs within the last month; 8. According to the judgment of the leading researchers, patients with serious complications or diseases may be at inappropriate risk or interfere with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone marrow aspiration;Routine blood test;electrocardiogram; | — |
Countries
China
Contacts
Public ContactZhou Jian
Cancer Hospital Affiliated to Zhengzhou University-He'nan Cancer Hospital
Outcome results
None listed