Status:
UNKNOWN
Cyclosporine on Day Zero as Prophylaxis for Cytokine Release Syndrome
Lead Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Conditions:
Stem Cell Transplant Complications
Cytokine Release Syndrome
Eligibility:
All Genders
16-60 years
Phase:
PHASE2
Brief Summary
Phase II, randomized controlled, unblinded clinical trial. Will evaluate whether the administration of oral cyclosporine started on day 0 of transplantation is effective in reducing the incidence of c...
Detailed Description
CRS is usually limited after the administration of post-transplant cyclosporine (PT-CsA) administered on days +3 and +4, however, there is no standard prevention or treatment regimen for CRS after hap...
Eligibility Criteria
Inclusion
- Patients between 16-60 years of age who receive their first haploidentical transplant.
Exclusion
- Patients positive for the human immunodeficiency virus (HIV), Hepatitis B or C virus
- Pregnancy or lactation
- Patients with documented infection at the time of transplantation
- Presence of previous autoimmune diseases
- Inability to tolerate the oral route
Key Trial Info
Start Date :
March 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 17 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04781803
Start Date
March 25 2021
End Date
February 17 2023
Last Update
March 5 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario Dr. José E. González, Centro Universitario contra el Cáncer
Monterrey, Nuevo León, Mexico, 64460