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 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2025-11-25
Summary
The purpose of this study is to assess the efficacy and safety of ruxolitinib therapy in Chinese adults and adolescents (≥ 12 years old) with Grade II-IV steroid-refractory acute graft versus host disease (SR-aGvHD).
Conditions
- Steroid-refractory Acute Graft Versus Host Disease
Interventions
- DRUG
-
Ruxolitinib is taken orally daily at 10 mg BID, given as two 5-mg tablets.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-04
- Primary Completion
- 2027-01-04
- Completion
- 2028-02-17
Countries
- China
Study Locations
More Related Trials
-
Ruxolitinib In GvHD
NCT02396628 ·Status: TERMINATED ·Phase: PHASE2
-
Itacitinib for Low Risk GVHD
NCT03846479 ·Status: COMPLETED ·Phase: PHASE2
-
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 Ruxolitinib in Sclerotic Chronic Graft-Versus-Host Disease After Failure of Systemic Glucocorticoids
NCT03616184 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms
NCT06034002 ·Status: RECRUITING ·Phase: PHASE1
-
Ruxolitinib as First Line Treatment in Primary Haemophagocytic Lymphohistiocytosis (R-HLH)
NCT05762640 ·Status: RECRUITING ·Phase: PHASE2
-
Topical Ruxolitinib for Cutaneous Chronic Graft Versus Host Disease (cGVHD)
NCT03395340 ·Status: TERMINATED ·Phase: PHASE2
-
A Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1)
NCT02953678 ·Status: COMPLETED ·Phase: PHASE2
-
Expanded Access of Ruxolitinib Cream to Treat a Single Patient With cGVHD
NCT05722912 ·Status: APPROVED_FOR_MARKETING
-
Donor Regulatory T-cells for cGVHD in Patients Who do Not Obtain Complete Remission With Ruxolitinib
NCT05095649 ·Status: RECRUITING ·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
-
Ruxolitinib Plus Fostamatinib for Steroid Refractory cGvHD
NCT06233110 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of Rituximab Combined With Prednisone for the Initial Treatment of Chronic Graft Versus Host Disease (cGVHD)
NCT01066598 ·Status: TERMINATED ·Phase: PHASE2
-
Ruxolitinib in Treating Patients With Hypereosinophilic Syndrome or Primary Eosinophilic Disorders
NCT03801434 ·Status: RECRUITING ·Phase: PHASE2
-
Donor Regulatory T-cells for Steroid-Refractory Chronic Graft-versus-host-Disease
NCT03683498 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
NCT05755438 ·Status: COMPLETED ·Phase: PHASE3
-
Topical Ruxolitinib Evaluation in Immune-related Lichenoid Skin-Toxicities
NCT06399029 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Efficacy and Safety of Ruxolitinib in the Treatment of Anemic Myelofibrosis Patients.
NCT02966353 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Participants With Steroid Dependent/Refractory Chronic Graft Versus Host Disease (cGVHD)
NCT03474679 ·Status: COMPLETED ·Phase: PHASE3
-
First-Line Jaktinib for Acute Graft-Versus-Host Disease (aGVHD)
NCT07285889 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Ruxolitinib Combined With Dexamethasone for HLH
NCT03795909 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Ruxolitinib Cream in Participants With Facial and/or Neck Atopic Dermatitis Involvement
NCT05127421 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute GVHD
NCT02614612 ·Status: COMPLETED ·Phase: PHASE1
-
Safety Study of Rituximab (Rituxan®) in Chronic Urticaria
NCT00216762 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
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