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Vedolizumab, Anti-CD25 Antibody, Rapid Reduction of Glucocorticoids for SR-aGVHD With Gastrointestinal Involvement

NCT06066840 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-10-04

No results posted yet for this study

Summary

Acute graft-versus-host disease (aGVHD) is the most common life-threatening complication of allogeneic hematopoietic stem cell transplantation. The investigators try to observe the efficacy and safety of application of vedolizumab, anti-CD25 monoclonal antibody and rapid reduction of glucocorticoids in the treatment of grade 3-4 steroid-refractory aGVHD(SR-aGVHD) with lower gastrointestinal involvement.

Conditions

  • Safety and Efficacy

Interventions

DRUG

Basiliximab

Basiliximab is a second-line treatment for steroid-resistant acute graft-versus-host disease.

DRUG

Vedolizumab

Vedolizumab is a second-line treatment for steroid-resistant acute graft-versus-host disease.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    collaborator OTHER

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    collaborator OTHER

  • Affiliated Hospital of Nantong University

    collaborator OTHER

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Principal Investigators

  • Xuefeng He, doctor · The First Affiliated Hospital of Soochow University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2025-07-31
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 NCT06066840 on ClinicalTrials.gov