Cyclosporine on Day Zero as Prophylaxis for Cytokine Release Syndrome

• Status: Recruiting
• Trial end date: 2023-02-17
• Target enrollment: 0
• Participant gender: All

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 cytokine release syndrome (CRS) in patients who receive an outpatient haploidentical transplant.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
• Treatments: Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

• Patients between 16-60 years of age who receive their first haploidentical transplant.

Exclusion Criteria:

• 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