Treatment for severe acute graft-versus-host disease with vedolizumab and anti-CD25 antibody
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
This study is testing a new combination treatment for adults with severe acute graft-versus-host disease who haven't improved with steroids to see if it helps them feel better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Soochow University Academic / other |
| Drugs / interventions | vedolizumab, Basiliximab |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT06066840 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of vedolizumab and an anti-CD25 monoclonal antibody in treating grade 3-4 steroid-refractory acute graft-versus-host disease (SR-aGVHD) with gastrointestinal involvement. Participants aged 18-65 who have not responded to systemic steroids will receive a combination therapy of vedolizumab and basiliximab, with a rapid reduction of glucocorticoids. The study aims to assess the treatment's effectiveness in improving patient outcomes and managing symptoms associated with this severe condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 diagnosed with grade 3-4 steroid-refractory acute graft-versus-host disease with gastrointestinal involvement.
Not a fit: Patients with refractory graft-versus-host disease, severe complications, or those with a life expectancy of less than 60 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from severe SR-aGVHD, potentially improving their quality of life and survival rates.
How similar studies have performed: While there have been studies on treatments for aGVHD, this specific combination therapy approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Suzhou, Jiangsu
- The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Xuefeng He, doctor — The First Affiliated Hospital of Soochow University
- Study coordinator: Xuefeng He, doctor
- Email: hexuefeng@suda.edu.cn
- Phone: 86-18914031640
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.