Cyclosporine on Day Zero as Prophylaxis for Cytokine Release Syndrome

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez (Other)

Overall Status

Recruiting

CT.gov ID

NCT04781803

Collaborator

(none)

Enrollment

Location

Arms

22.8

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stem Cell Transplant Complications Cytokine Release Syndrome	Drug: Cyclosporine	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Mar 25, 2021

Anticipated Primary Completion Date :

Jan 17, 2023

Anticipated Study Completion Date :

Feb 17, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 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 Cyclosporine 6 mg/kg and mycophenolic acid 1 gram orally on day 0 post-transplant
No Intervention: Arm 2 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

Arm

Intervention/Treatment

Experimental: Arm 1

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

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

No Intervention: Arm 2

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

Outcome Measures

Primary Outcome Measures

Cytokine Release Syndrome [day 0 to day 30]
Presence of Fever, hypotension, hypoxemia

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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