NCT02513498

Ixazomib Citrate in Treating Patients With Chronic Graft-versus-Host Disease

Ixazomib for Treatment of Chronic Graft vs. Host Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (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 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.

Detailed description

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.

Conditions

• Chronic Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	Ixazomib Citrate	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2015-12-08
• Primary completion: 2018-01-05
• Completion: 2018-06-27
• First posted: 2015-07-31
• Last updated: 2019-02-06
• Results posted: 2019-02-06

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study