Preventing Ocular Graft-versus-host Disease with Tacrolimus vs Cyclosporine
Evaluation of Safety and Efficacy for the Prevention of Ocular Graft-versus-host Disease With Ophthalmic Tacrolimus vs. Ophthalmic Cyclosporine in Non-myeloablative Allogeneic Hematopoietic Stem Cell Transplant Recipients
This study is testing whether tacrolimus ointment can better prevent eye problems from graft-versus-host disease in patients who have just had a stem cell transplant compared to cyclosporine eye drops.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitario Dr. Jose E. Gonzalez Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nuevo León, Monterrey) |
| Trial ID | NCT06348602 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of tacrolimus ointment compared to cyclosporine eye drops for preventing ocular graft-versus-host disease (GVHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Participants will be randomized to receive one of the two treatments after their transplant, and their ocular health will be monitored through standardized evaluations. The study aims to determine if tacrolimus can provide better protection against ocular complications associated with GVHD than the currently accepted treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are undergoing allogeneic HSCT.
Not a fit: Patients with previous rheumatic diseases or uncontrolled thyroid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention strategies for ocular GVHD, potentially reducing vision loss and enhancing quality of life for patients.
How similar studies have performed: Previous studies have shown that ocular cyclosporine drops can be effective for ocular GVHD, but the use of tacrolimus in this context is less established, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients undergoing allogeneic HSCT. 2. Patients 18 years of age or older. 3. Patients who agree to participate in the study and sign the informed consent document. Exclusion Criteria: 1. Patients undergoing HSCT who do not continue their evaluation and follow-up in the Hematology Service of the University Hospital. 2. Patients under 18 years of age. 3. Patients who do not agree to participate in the study. 4. Patients diagnosed with previous rheumatic disease. 5. Patients with dermatological conditions undergoing systemic treatment. 6. Patients with uncontrolled thyroid disease.
Where this trial is running
Nuevo León, Monterrey
- Hospital Universitario de la U.A.N.L. — Nuevo León, Monterrey, Mexico (Recruiting)
Study contacts
- Study coordinator: Olga Graciela Cantú Rodríguez, MD
- Email: ogcantur@yahoo.com.mx
- Phone: 8186939257
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.