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

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Soochow University
• Collaborators: Affiliated Hospital of Nantong University; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; The First Affiliated Hospital with Nanjing Medical University
• Treatments: Antibodies; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Basiliximab; Immunoglobulins; Vedolizumab

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Refractory/secondary graft-versus-host disease.

• Severe complications such as myocardial infarction, chronic cardiac insufficiency,

• hepatic failure, renal insufficiency, etc.

• Clinically uncontrolled active infections.

• Other Malignant tumors with progression.

• Heart failure: EF<30%, NYHA≥grade III.

• Pregnant or lactating women.

• Expected survival <60 days.

• Undergoing other drug clinical trials.