Objectives 2.1 Primary objectives 1\) To observe and compare incidence and severity of aGVHD and cGVHD between the two arms within 2 years after transplantation. 2\) To observe and compare the engraftment rate between the two arms. 3) To observe and compare the incidence of infections between the two arms. 2.2 Secondary objectives 1. To conduct pharmacogenomic assay in CD20 arm(treatment arm) before conditioning and monitor plasma concentration of CD20 dynamically(7d、14d、28d、56d、91d). 2. To monitor levels of B cells in peripheral blood dynamically (+90d、+180d、+270d、+360d、+450d、+540d、+630d、+720d) in all patients. 3. To observe and compare the incidence of PTLD between the two arms. 4. To observe and compare immunoglobulin levels after transplantation in all patients. 5. To evaluate transplant-related mortality. 6. To evaluate the effect on hematopoietic reconstruction.
3\. Study design 3.1 Principle of design: prospective, randomized, control, open label 3.2 Subjects: patients with SAA undergoing allogeneic HSCT 3.3 Grouping: In this study, central randomization was used for random enrolment (1:1). After signing the informed consent, patients were randomized into rituximab conditioning group (test group) or non- rituximab conditioning group (control group). Treatment was assigned on a randomized basis according to a 1:1 ratio. The test group and the control group each will include 100 cases. 3.4 Study schedule: This clinical research is to be completed from September 2020 to September 2023. 1. Subject enrollment 36months 2. Transplantation to the end of follow-up 24months 3. Data collection and report writing 3months In total 63months
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
4.2 Conditioning Regimen 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) 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 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) 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
4.2 Conditioning Regimen 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) 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 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) 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
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGGVHD incidence
GVHD incidence, location and grade. Infection incidence and recurrence rate.
Time frame: 2 years
Infection incidence
Cumulative incidence of infection post-transplant
Time frame: 2 years
GVHD-free survival rate
defined by the percentage of patients who are alive without evidence of moderate or severe chronic GVHD at 2 year
Time frame: 2 years
transplant related mortality
Defined as the number of days from the date of transplant to the date of death related to transplant
Time frame: 2 years
overall survival rate
OS is defined as the number of days from the date of transplant to the date of death
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.