Cyclosporine on Day Zero as Prophylaxis for Cytokine Release Syndrome

NCT04781803 | Unknown Phase 2

• 1 other identifier: HE21-00003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Stem Cell Transplant Complications; Cytokine Release Syndrome

Keywords

Cyclosporin; Haploidentical; Outpatient

Outcome Measures

Primary Outcomes (1)

• Cytokine Release Syndrome

  Presence of Fever, hypotension, hypoxemia

  day 0 to day 30

Study Arms (2)

Arm 1

EXPERIMENTAL

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.

Drug: Cyclosporine

Arm 2

NO INTERVENTION

Cyclosporine 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

Interventions

Cyclosporine DRUG

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

Arm 1

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Hospital Universitario Dr. José E. González, Centro Universitario contra el Cáncer

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

MeSH Terms

Conditions

Cytokine Release Syndrome

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Oscar González-Llano, MD

  Hospital Universitario ¨Dr. José Eleuterio González

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Perla R Colunga-Pedraza, MD

CONTACT

528183488510; colunga.perla@gmail.com

Julia Colunga-Pedraza, MD

CONTACT

528183486136; julia_ecp@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of service

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: March 25, 2021
• Primary Completion: January 17, 2023
• Study Completion: February 17, 2023
• Last Updated: March 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)