Tocilizumab for Chronic Graft-versus-Host Disease Treatment
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|ClinicalTrials.gov Identifier: NCT02174263|
Recruitment Status : Withdrawn (Study never opened due to lack of funds.)
First Posted : June 25, 2014
Last Update Posted : May 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Graft Versus Host Disease||Biological: tocilizumab Other: laboratory biomarker analysis Other: quality-of-life assessment||Phase 2|
I. Efficacy will be determined by the proportion of patients with failure free survival (FFS) at 6 months.
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).
I. Biologic studies will be done to determine possible mechanisms of response.
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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Tocilizumab in Chronic GVHD Refractory to at Least Two Prior Therapies|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||August 2019|
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).
Other: laboratory biomarker analysis
Other: quality-of-life assessment
Other Name: quality of life assessment
- 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 [ Time Frame: Baseline to 6 months ]Prednisone is not a pre-specified intervention; however, some patients may take prednisone while on this study.
- B cell subsets [ Time Frame: Up to week 21 ]
- Tumor necrosis factor (ligand) superfamily, member 13b (BAFF) levels [ Time Frame: Up to week 21 ]
- T cell subsets [ Time Frame: Up to week 21 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174263
|United States, Arizona|
|Mayo Clinic Hospital|
|Phoenix, Arizona, United States, 85054|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232|
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Stephanie Lee||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|