GVHD Prophylaxis by Addition of CD20 Monoclonal Antibody to the Conditioning Regimen in SAA With Treatment of Allo-HSCT

PHASE2RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

December 30, 2021

Primary Completion Date

September 30, 2023

Study Completion Date

December 31, 2025

Conditions
Aplastic Anemia
Interventions
DRUG

CD20 monoclonal antibody

"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"

DRUG

ATG

"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"

Trial Locations (1)

215215

RECRUITING

The First Affiliated Hospital of Soochow University, Suzhou

All Listed Sponsors
lead

The First Affiliated Hospital of Soochow University

OTHER