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

NCT05510505 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-08-24

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Principal Investigators

  • depei wu · The First Affiliated Hospital of Soochow University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-30
Primary Completion
2023-09-30
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05510505 on ClinicalTrials.gov