NCT02174263

Tocilizumab for Chronic Graft-versus-Host Disease Treatment

Tocilizumab in Chronic GVHD Refractory to at Least Two Prior Therapies

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. Efficacy will be determined by the proportion of patients with failure free survival (FFS) at 6 months. SECONDARY OBJECTIVES: I. Patients achieving a complete response (CR) or partial response (PR) at 6 months based on clinician judged response. II. Patients achieving a CR or PR by objective response measures at 6 months. III. Failure-free survival (FFS) at 1 year. IV. Change in steroid dose from enrollment to 6 months (mo). TERTIARY OBJECTIVES: I. Biologic studies will be done to determine possible mechanisms of response. OUTLINE: Patients receive tocilizumab intravenously (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). After completion of study treatment, patients are followed up at 3 and 6 months.

Conditions

• Graft Versus Host Disease

Interventions

Type	Name	Description
BIOLOGICAL	tocilizumab	Given IV
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	quality-of-life assessment	Ancillary studies

Timeline

• Start date: 2016-02-01
• Primary completion: 2019-08-01
• First posted: 2014-06-25
• Last updated: 2016-05-06

Locations

5 sites across 1 country: United States