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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Mayo Clinic Hospital
Phoenix, Arizona, United States
Mayo Clinic
Rochester, Minnesota, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
FFS
Time frame: At 6 months
Patients achieving CR or PR based on objective measures, as recommended by the NIH Consensus Conference for chronic GVHD
Time frame: At 6 months
Patients achieving a CR or PR based on clinician judged response
Time frame: At 6 months
Relative change in daily prednisone dose
Prednisone is not a pre-specified intervention; however, some patients may take prednisone while on this study.
Time frame: Baseline to 6 months
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Medical College of Wisconsin
Milwaukee, Wisconsin, United States