NCT05510505

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

A Prospective, Randomized, Multi-center Study to Assess the Efficacy and Safety of GVHD Prophylaxis by Addition of CD20 Monoclonal Antibody to the Conditioning Regimen in Severe Aplastic Anemia Patients With Treatment of Allogeneic HSCT

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Aplastic Anemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-12-30
• Primary completion: 2023-09-01
• Completion: 2025-12-01
• First posted: 2022-08-22
• Last updated: 2022-08-24

Locations

1 site across 1 country: China