Cyclosporine on Day Zero as Prophylaxis for Cytokine Release Syndrome

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stem Cell Transplant Complications, Cytokine Release Syndrome

Intervention / Treatment
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* Drug: Cyclosporine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>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<br>* Cyclosporine 6 mg/kg and mycophenolic acid 1 gram orally on day 0 post-transplant<br>|
| No Intervention: Arm 2<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine Release Syndrome | Presence of Fever, hypotension, hypoxemia | day 0 to day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cyclosporin, Haploidentical, Outpatient