Cyclosporine on Day Zero as Prophylaxis for Cytokine Release Syndrome

Phase 2

• Conditions: Stem Cell Transplant Complications; Cytokine Release Syndrome
• Interventions: Drug: Cyclosporine

• Registration Number: NCT04781803
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

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

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 haplo-TCPH and therapeutic behavior has usually been adopted.

Sample of 32 patients between the ages of 16 and 60 who receive their first haploidentical transplant at our center. In the control group, CsA 6 mg/kg orally divided into two doses per day starting in the morning on day +5 of the transplant, mycophenolic acid 1 gram orally (2 tablets of 500 mg) from day +5 post-transplant and post-transplant cyclophosphamide (PT-CY) at 50 mg/kg per day on days +3 and +4 and in the experimental group, CsA 6 mg/kg orally divided into two doses per day starting in the morning on day 0 after transplantation, mycophenolic acid 1 gram orally (2 tablets 500 mg) from day 0 post-transplant and PT-CY at 50 mg/kg per day on day +3 and +4.

Will document the presence of CRS and its degree, as well as the need for hospitalization, associated infectious processes, and a day to recover neutrophils and platelets. Additionally, 4 blood samples will be taken from the patients to determine the level of cytokines and C-reactive protein.

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-01
• Last Update Submitted: 2021-03-03
• Study First Posted: 2021-03-04
• Last Update Posted: 2021-03-05
• Study Start: 2021-03-25
• Primary Completion: 2023-01-17
• Study Completion: 2023-02-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Cyclosporine	Cyclosporine 6 mg/kg orally divided into two doses per day starting in the morning on day 0 after transplantation, mycophenolic acid 1 gram orally (2 tablets 500 mg) from day 0 post-transplant and PT-CY at 50 mg/kg per day on day +3 and +4.

Primary Outcome Measures

Name	Time	Method
Cytokine Release Syndrome	day 0 to day 30	Presence of Fever, hypotension, hypoxemia

Trial Locations

Locations (1)

Hospital Universitario Dr. José E. González, Centro Universitario contra el Cáncer; 🇲🇽 Monterrey, Nuevo Leon, Mexico