A Study of Itacitinib for the Treatment of Chronic Graft Versus Host Disease (cGVHD)
NCT04200365 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2024-11-06
Summary
This study is being done in patients who have been receiving corticosteroids or other immunosuppressive therapies for the treatment of cGVHD for at least 6 months. The purpose of this study is to find out if itacitinib in combination with corticosteroids or other immunosuppressive therapies is safe and effective in people with cGVHD.
Conditions
- Chronic Graft-versus-host-disease
Interventions
- DRUG
-
Itacitinib
Itacitinib will be administered orally once daily for up to 24 months.
Sponsors & Collaborators
- collaborator INDUSTRY
-
SCRI Development Innovations, LLC
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-06-05
- Primary Completion
- 2023-09-07
- Completion
- 2023-09-07
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease
NCT03139604 ·Status: COMPLETED ·Phase: PHASE3
-
Itacitinib for Low Risk GVHD
NCT03846479 ·Status: COMPLETED ·Phase: PHASE2
-
Itacitinib and Tocilizumab for Steroid Refractory Acute Graft Versus Host Disease
NCT04070781 ·Status: TERMINATED ·Phase: PHASE1
-
A Study of IBI377 in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease
NCT04220632 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Safety of Itacitinib in Combination With Corticosteroids for Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese Subjects
NCT03497273 ·Status: COMPLETED ·Phase: PHASE1
-
A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib
NCT04640025 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors
NCT05660421 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Study of Rituximab Combined With Prednisone for the Initial Treatment of Chronic Graft Versus Host Disease (cGVHD)
NCT01066598 ·Status: TERMINATED ·Phase: PHASE2
-
Safety and Clinical Activity of Itolizumab in aGVHD
NCT05823675 ·Status: UNKNOWN ·Phase: PHASE1
-
A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy
NCT04071366 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
NCT06585774 ·Status: RECRUITING ·Phase: PHASE3
-
Ibrutinib and Rituxan for Chronic GVHD
NCT04235036 ·Status: TERMINATED ·Phase: PHASE2
-
Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)
NCT02959944 ·Status: COMPLETED ·Phase: PHASE3
-
Study of the Safety and Efficacy of Ruxolitinib Cream for Non-Sclerotic Chronic Cutaneous Graft-Versus-Host Disease
NCT03954236 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Chronic Graft Versus Host Disease
NCT02195869 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Treatment of Non Severe Hemophagocytosis Lymphohistiocytosis With ITACITINIB
NCT05063110 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease
NCT06388564 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Axatilimab for Sclerotic Chronic Graft-versus-Host Disease
NCT07011810 ·Status: RECRUITING ·Phase: PHASE2
-
Expanded Access of Ruxolitinib Cream to Treat a Single Patient With cGVHD
NCT05722912 ·Status: APPROVED_FOR_MARKETING
-
Topical Ruxolitinib for Cutaneous Chronic Graft Versus Host Disease (cGVHD)
NCT03395340 ·Status: TERMINATED ·Phase: PHASE2
-
Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo
NCT04530344 ·Status: COMPLETED ·Phase: PHASE3
-
Donor Regulatory T-cells for Steroid-Refractory Chronic Graft-versus-host-Disease
NCT03683498 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 2 Trial of Rituximab and Corticosteroid Therapy for Newly Diagnosed Chronic Graft Versus Host Disease
NCT00350545 ·Status: COMPLETED ·Phase: NA
-
Study of Efficacy and Safety of Ruxolitinib in Patients With Grade II to IV Steroid-refractory Acute Graft vs. Host Disease
NCT06462469 ·Status: RECRUITING ·Phase: PHASE4
-
Analysis of Patients Treated for Chronic Granulomatous Disease Since January 1, 1995
NCT02116764 ·Status: COMPLETED