Cyclosporine on Day Zero as Prophylaxis for Cytokine Release Syndrome

Stem Cell Transplant Complications Clinical Trial

Official title:

Cyclosporine on Day Zero as Prophylaxis for Cytokine Release Syndrome in Outpatient Haploidentical Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04781803
• Other study ID #: HE21-00003
• Status: Recruiting
• Phase: Phase 2
• Start date: March 25, 2021
• Est. completion date: February 17, 2023

Study information

• Verified date: March 2021
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: Perla R Colunga-Pedraza, MD
• Phone: 528183488510
• Email: colunga.perla[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: February 17, 2023
• Est. primary completion date: January 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cytokine Release Syndrome
• Stem Cell Transplant Complications
• Syndrome

Intervention

Drug:
• Cyclosporine
Cyclosporine 6 mg/kg and mycophenolic acid 1 gram orally on day 0 post-transplant

Locations

Country	Name	City	State
Mexico	Hospital Universitario Dr. José E. González, Centro Universitario contra el Cáncer	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytokine Release Syndrome	Presence of Fever, hypotension, hypoxemia	day 0 to day 30