Tocilizumab for Chronic Graft-versus-Host Disease Treatment

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT02174263
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • tocilizumab — BIOLOGICAL
    Given IV
  • laboratory biomarker analysis — OTHER
    Correlative studies
  • quality-of-life assessment — OTHER
    Ancillary studies

Study Details

This phase II trial studies how well tocilizumab works in treating chronic graft-versus-host disease (GVHD) in patients that have not responded to treatment after at least two prior therapies. Tocilizumab blocks a protein that stimulates the body's immune system. By blocking this protein, the investigators may reduce the symptoms of chronic GVHD.

Key Dates

Start date
Feb 29, 2016
Status verified
May 2016
Primary completion
Aug 31, 2019

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Supportive care (tocilizumab)
    Patients receive tocilizumab IV over 1 hour every 2 weeks for 12 weeks (weeks 1, 3, 5, 7, 9, and 11) and then every 4 weeks for 12 weeks (weeks 13, 17, and 21).

Primary Outcome Measure

FFS [ Time Frame: At 6 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
Mayo Clinic HospitalPhoenixArizona85054-
Mayo ClinicRochesterMinnesota55905-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattleWashington98109-
Medical College of WisconsinMilwaukeeWisconsin53226-

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