Ignite Creation Date:
2025-12-24 @ 2:34 PM
Ignite Modification Date:
2026-01-14 @ 2:07 AM
Study NCT ID:
NCT02491359
Status:
COMPLETED
Last Update Posted:
2019-02-06
First Post:
2015-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Carfilzomib in Treating Patients With Chronic Graft-Versus-Host Disease
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Study Overview
Official Title:
Carfilzomib for Treatment of Chronic Graft vs. Host Disease
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2015-00809 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 9228.00 | None | None | View | |
| 9228 | OTHER | Fred Hutch/University of Washington Cancer Consortium | View | |
| P30CA015704 | NIH | None | https://reporter.nih.gov/quic… | View |