Vedolizumab, Anti-CD25 Antibody Combined With Rapid Reduction of Glucocorticoids as Treatment of Grade 3-4 Steroid-resistant Acute Graft-versus-host Disease With Lower Gastrointestinal Involvement

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Clinical diagnosis of grade 3-4(according to MAGIC criteria) steroid-resistant acute graft-versus-host disease(progression after 3 days or lack of improvement after 5 days of systemic 1.5-2 mg/kg steroids) with gastrointestinal involvement.

• Age 18-65.

• ECOG score≤3.

• Must be able to understand and willing to participate in the study and sign the informed consent.

Locations
Other Locations
China
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Contact Information
Primary
Xuefeng He, doctor
hexuefeng@suda.edu.cn
86-18914031640
Backup
Fei Zhou, doctor
zhoufei@suda.edu.cn
86-15051425673
Time Frame
Start Date: 2022-08-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 45
Treatments
Experimental: vedolizumab+basiliximab
Patients with steroid-refractory aGVHD with gastrointestinal involvement receive combined therapy of vedolizumab and basiliximab.
Related Therapeutic Areas
Sponsors
Collaborators: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Affiliated Hospital of Nantong University, The First Affiliated Hospital with Nanjing Medical University
Leads: The First Affiliated Hospital of Soochow University

This content was sourced from clinicaltrials.gov