Chronic Graft Versus Host Disease Clinical Trial
Official title:
Ixazomib for Treatment of Chronic Graft vs. Host Disease
This phase II trial studies how well ixazomib citrate 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. Ixazomib citrate may be an effective treatment for chronic graft-versus-host disease.
PRIMARY OBJECTIVES:
I. Determine the proportion of subjects with treatment failure by 6 months of ixazomib
(ixazomib citrate) treatment 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-suppressive therapy 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)], Human Activity Profile
[HAP]) at study enrollment, 6 months, and 1 year.
V. Study biologic effects of proteasome inhibition.
OUTLINE:
Patients receive ixazomib citrate orally (PO) once weekly on days 1, 8, and 15. Treatment
repeats every 28 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity. Patients with complete response, partial response, or stable disease
may receive an additional 6 courses of ixazomib citrate.
After completion of study treatment, patients are followed up for 6 months.
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