Tocilizumab for Cytokine Release Syndrome Prophylaxis in Haploidentical Transplantation

Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Study ID
NCT03533101
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Cytokine Release Syndrome
  • Stem Cell Transplant Complications

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    IL-6 receptor antibody pre-transplant administration to avoid cytokine release syndrome

Study Details

Tocilizumab will be administered prior to transplantation in order to prevent the onset of cytokine release syndrome and its complications associated to peripheral blood haploidentical hematopoietic stem cell transplantation with post-transplant cyclophosphamide

Key Dates

Start date
May 25, 2018
Status verified
Mar 2021
Primary completion
May 15, 2019
Completion
Jun 15, 2019

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Tocilizumab 4 mg/kg
    Tocilizumab 4 mg/kg IV single dose day -1 prior to haploidentical transplantation
  • Active Comparator: Tocilizumab 8 mg/kg
    Tocilizumab 8 mg/kg IV single dose day -1 prior to haploidentical transplantation

Primary Outcome Measure

Cytokine release syndrome [ Time Frame: 1 week ]

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