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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT01804686 -
A Long-term Extension Study of PCI-32765 (Ibrutinib)
|
Phase 3 | |
| Terminated |
NCT02337517 -
Vismodegib in Treating Patients With Steroid-Refractory Chronic Graft-Versus-Host Disease
|
Phase 2 | |
| Terminated |
NCT02461134 -
Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of Ponesimod in Subjects With Symptomatic Chronic GVHD
|
Phase 2 | |
| Recruiting |
NCT03839069 -
Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis
|
N/A | |
| Active, not recruiting |
NCT00637689 -
Improving Outcomes Assessment in Chronic GVHD
|
||
| Not yet recruiting |
NCT06233110 -
Ruxolitinib Plus Fostamatinib for Steroid Refractory cGvHD
|
Phase 1 | |
| Active, not recruiting |
NCT01937468 -
Trial of Regulatory T-cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic Graft-versus-Host-Disease
|
Phase 1 | |
| Completed |
NCT01810718 -
Phase I/II for Safety and Efficacy of Nilotinib in a Population Steroid-refractory/or Steroid-dependent cGVHD
|
Phase 1 | |
| Completed |
NCT01380535 -
Extracorporeal Photopheresis (ECP) With Methoxsalen for Chronic Graft Versus Host Disease (cGVHD)
|
Early Phase 1 | |
| Terminated |
NCT01964625 -
Positron Emission Tomography - Computed Tomography (PET-CT) Scanning in Chronic Graft Versus Host Disease (cGvHD)
|
N/A | |
| Active, not recruiting |
NCT03790332 -
Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)
|
Phase 1/Phase 2 | |
| Completed |
NCT01680965 -
Ofatumumab as Primary Therapy of Chronic Graft Versus Host Disease
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06300320 -
A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease
|
Phase 2 | |
| Recruiting |
NCT05922761 -
BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)
|
Phase 2 | |
| Terminated |
NCT02701634 -
Efficacy and Tolerability of Entospletinib in Combination With Systemic Corticosteroids as First-Line Therapy in Adults With Chronic Graft Versus Host Disease (cGVHD)
|
Phase 2 | |
| Recruiting |
NCT06247150 -
Tissue Immune Landscape of Graft Versus Host Disease After Allogeneic Stem Cell Transplantation (TIL-GVHD)
|
N/A | |
| Active, not recruiting |
NCT04212416 -
Leflunomide in Treating Patients With Steroid Dependent Chronic Graft Versus Host Disease
|
Phase 1 | |
| Completed |
NCT02959944 -
Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)
|
Phase 3 | |
| Completed |
NCT01954979 -
Abatacept to Treat Steroid Refractory Chronic Graft Versus Host Disease (cGVHD)
|
Phase 1 | |
| Active, not recruiting |
NCT04640025 -
A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib
|
Phase 2 |