Status:
UNKNOWN
Vedolizumab, Anti-CD25 Antibody, Rapid Reduction of Glucocorticoids for SR-aGVHD With Gastrointestinal Involvement
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Collaborating Sponsors:
The First Affiliated Hospital with Nanjing Medical University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Safety and Efficacy
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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...
Detailed Description
Sample size: According to Simon optimal two-stage design, P0=60%, P1=80%, α=0.05, β=0.2, a sample size of 45 was chosen. Objects: Adults ages 18-65 diagnosed with grade 3-4 SR-aGVHD with lower gastro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06066840
Start Date
August 1 2022
End Date
December 31 2025
Last Update
October 4 2023
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006