GVHD Prophylaxis by Addition of CD20 Monoclonal Antibody to the Conditioning Regimen in SAA With Treatment of Allo-HSCT
Aplastic Anemia
About this trial
This is an interventional treatment trial for Aplastic Anemia
Eligibility Criteria
Inclusion Criteria:
Subjects eligible for inclusion in this study must meet all of the following criteria:
- SAA characterized Bone marrow cellularity< 25%, or 25-50% with <30% residual hematopoietic cells and pancytopenia, with at least two of the following parameters in peripheral blood Absolute neutrophil count < 0.5*10E9/L Platelet count < 20*10E9/L Absolute reticulocyte count < 20*10E9/L
- ALL patients will undergo allo-HSCT.
- Subjects aged <50 years old with KPS performance status ≥70 at the same time.
- Aspartate aminotransferase (AST) , alanine aminotransferase (ALT) and alkaline phosphatase≤2 times the upper limit of normal (ULN). Blood urea nitrogen and Creatinine ≤1.25 times ULN.
- Cardiac function of subjects must meet all of the following requirements: ECG examination do not reveal any acute myocardial infarction, arrhythmia, or first-degree or higher atrioventricular block. No signs of heart failure. No carrying of active rheumatoid heart disease. Chest radiograph or physical examination do not indicate an enlarged heart.
- ALL subjects show none contraindication for allogeneic hematopoietic stem cell transplantation.
- Patients enrolled in the rituximab group have no contraindications for the use of rituximab.
- Patients and their clients are willing to perform hematopoietic stem cell transplantation.
- Potential donor is accessible.
- Patients have no anti-HLA antibodies.
Exclusion Criteria:
- Subject who is unable comprehend or is unwilling to sign an informed consent form or consent form due to severe physical or mental illness resulting in a survival of less than 2 years.
- Presence of clinically active uncontrolled significant chronic infections (including bacterial, fungal or viral infection), such as dental caries, otitis media, sinusitis, etc., need to be carried out after effective control.
- Past medical history of severe pulmonary dysfunction.
- Past medical history of diabetes with a propensity for ketoacidosis.
- Presence of severe coagulopathy, thrombophlebitis or pulmonary embolism.
- Presence of decompensated liver insufficiency or active hepatitis.
- Presence of history of severe autoimmune disease.
- Past medical history of thyroid dysfunction with currently abnormal thyroid function.
- Any concomitant malignancies that have not been disease-free for 5 years.
- Past medical history of hypersensitivity to biological products (including antibiotics).
- Pregnant or nursing woman.
- Inherited bone marrow failure.
Sites / Locations
- The First Affiliated Hospital of Soochow UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
ATG arm (control group)
ATG + CD20 monoclonal antibody (test arm)
4.2.1 Matched sibling donor 1) ATG arm (control group) Fludarabine 30mg/m2/d×6d(-7d ~ -2d)+ Cyclophosphamide 50mg/kg/d×2d (-4d ~ -3d)+ ATG 2.5mg/kg/d×5d(-8d ~ -4d) 4.2.2 Unrelated donor and haploidentical donor 1) ATG arm (control group) Busulfan 3.2 mg/kg/d(0.8 mg/kg,q6h)×2d(-7d ~ -6d) + Cyclophosphamide 50mg/kg/d×4d (-5d ~ -2d)+ ATG 2.5mg/kg/d×4d(-5d ~ -2d)
4.2.1 Matched sibling donor 2) ATG + CD20 monoclonal antibody (test arm) Fludarabine 30mg/m2/d×6d(-7d ~ -2d) + Cyclophosphamide 50mg/kg/d×2d (-4d ~ -3d)+ ATG 2.5mg/kg/d×5d(-8d ~ -4d)+ CD20 monoclonal antibody 375mg/m2, -1d 4.2.2 Unrelated donor and haploidentical donor 2) ATG + CD20 monoclonal antibody (test arm) Busulfan 3.2 mg/kg/d(0.8 mg/kg,q6h)×2d(-7d ~ -6d) + Cyclophosphamide 50mg/kg/d×4d (-5d ~ -2d)+ ATG 2.5mg/kg/d×4d(-5d ~ -2d)+ CD20 monoclonal antibody 375mg/m2, -1d