Chronic Graft Versus Host Disease Clinical Trial
Official title:
Carfilzomib for Treatment of Chronic Graft vs. Host Disease
This pilot phase II trial studies how well carfilzomib works in treating patients with chronic graft-versus-host disease. Chronic graft-versus-host disease is a complication of a donor bone marrow or blood cell transplant, usually occurring more than three months after transplant, in which donor cells damage the host tissue. Carfilzomib may be an effective treatment for chronic graft-versus-host disease.
PRIMARY OBJECTIVE:
I. Determine proportion of subjects with treatment failure by 6 months of carfilzomib therapy
for chronic graft-versus-host disease (GVHD).
SECONDARY OBJECTIVES:
I. Determine 3 month overall (complete + partial), and complete response rate.
II. Determine 6 month overall (complete + partial), and complete response rate.
III. Report overall survival, non-relapse mortality, primary malignancy relapse, failure-free
survival, treatment success, and discontinuation of immune suppression at 6 months and 1
year.
IV. Examine functional outcome (2-minute walk test) and patient-reported outcomes (Lee
Chronic GVHD Symptom Scale, quality of life [Short Form Health Survey (SF)-36, Functional
Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT) Questionnaire], Human Activity
Profile [HAP]) at study enrollment, 6 months, and 1 year.
V. Study biologic effects of proteasome inhibition.
OUTLINE:
Patients receive carfilzomib intravenously (IV) over approximately 30 minutes on days 1, 8,
and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3, 6, and 12 months.
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