Acute Leukemia (AL)
Conditions
Interventions
Intervention group:Received rotescept treatment (subcutaneous injection of rotescept at a dose of 1mg/kg was given both 7 days and 28 days after transplantation)
Sponsors
Zhujiang Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.The inclusion criterion was age ranging from 18 to 70 years old (including the boundary value); 2. Clinically diagnosed as acute leukemia; 3. Allogeneic hematopoietic stem cell transplantation has been performed; 4. The expected survival period is more than 3 months from the date of signing the informed consent form; 5. With my consent and having signed the informed consent form, I am willing and capable of complying with the planned visits, research treatments, laboratory tests and other research procedures; 6. The serum pregnancy test result of fertile women must be negative (women who have undergone surgical sterilization or menopause for at least two years are considered infertile). Male and female subjects of childbearing age agreed to use contraception during the study period. 7. Hemoglobin <80 g/L.
Exclusion criteria
Exclusion criteria: 1. Unsuitable organ function: (1) Creatinine clearance 2×ULN; (5) ALT or AST > 3×ULN; 2. Poorly controlled hypertension, defined as repeatedly occurring systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg after adequate treatment, or a history of hypertensive crisis or hypertensive encephalopathy; 3. Subjects with a history of other malignant tumors (excluding acute leukemia), unless the subject has been disease-free for >=5 years. However, subjects with the following histories/conditions are allowed to participate: (1) Basal or squamous cell carcinoma of the skin; (2) Cervical carcinoma in situ; (3) Breast carcinoma in situ; (4) Incidental histological finding of prostate cancer (T1a or T1b defined using the tumor, lymph node, metastasis clinical staging system); (5) Solid tumors that the investigator considers there is no other known active disease; 4. Subjects who have undergone major surgery within 8 weeks prior to enrollment must have fully recovered from any previous surgery before enrollment; 5. Subjects with a history of cerebrovascular accidents (including ischemic, embolic, and hemorrhagic cerebrovascular accidents), transient ischemic attacks, deep vein thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombotic history within 6 months prior to enrollment. Note: prior superficial thrombophlebitis is not an exclusion criterion; 6. Subjects with a history of epilepsy, uncontrolled cerebrovascular ischemia/hemorrhage, cerebellar disease, or other active central nervous system diseases; 7. Subjects with the following cardiac conditions within 6 months prior to enrollment: myocardial infarction, uncontrollable angina, acute decompensated heart failure, NYHA class III-IV heart failure, or uncontrollable arrhythmia (as determined by the investigator); 8. Uncontrollable activity, systemic fungal, bacterial, or viral infections; 9. Evidence of human immunodeficiency virus (HIV), active hepatitis B and/or active hepatitis C; 10. History of pure red cell aplasia and/or anti-erythropoietin antibody disease; 11. Any condition or concurrent medication that may interfere with the interpretation of study data; 12. Known allergy to rotezumab or any of its components.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with improved transfusion response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of drug-related adverse reactions;Time to Granulocyte Engraftment;Time to Platelet Engraftment; | — |
Countries
China
Contacts
Public ContactLiang Zhao
Zhujiang Hospital of Southern Medical University
Outcome results
None listed