Tocilizumab for Treatment of Steroid Refractory Acute Graft-versus-Host Disease

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT01475162
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Tocilizumab — DRUG
    Tocilizumab will be administered intravenously at a dose of 8 mg/kg once every three weeks for three doses. After Day 56 doses may be decreased to 4mg/kg once every three weeks depending on GVHD response.

Study Details

This trial designed to evaluate the toxicity and efficacy of tocilizumab in the treatment of steroid refractory acute graft versus host disease (GVHD).

Key Dates

Start date
Aug 8, 2011
Status verified
Jan 2020
Primary completion
Feb 17, 2016
Completion
Sep 29, 2018

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab
    Drug: Tocilizumab Other Names: Actemra Tocilizumab will be administered intravenously at a dose of 8 mg/kg once every three weeks for three doses. After Day 56 doses may be decreased to 4mg/kg once every three weeks depending on GVHD response.

Primary Outcome Measure

Number of Subjects Achieving Complete or Partial Response at Day 56 After Administration of Tocilizumab [ Time Frame: Day 56 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert Hospital/Medical College of Wisconsin-Clinical Cancer CenterMilwaukeeWisconsin53226-

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