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Cyclosporine on Day Zero as Prophylaxis for Cytokine Release Syndrome

NCT04781803 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-03-05

No results posted yet for this study

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

Interventions

DRUG

Cyclosporine

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

Sponsors & Collaborators

  • Hospital Universitario Dr. Jose E. Gonzalez

    lead OTHER

Principal Investigators

  • Oscar González-Llano, MD · Hospital Universitario ¨Dr. José Eleuterio González

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-25
Primary Completion
2023-01-17
Completion
2023-02-17

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04781803 on ClinicalTrials.gov