Clinical trial · Interventional
Ruxolitinib for Newly Diagnosed Bronchiolitis Obliterans Syndrome
Ruxolitinib for Newly Diagnosed Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Lung is one of the target organs in chronic graft versus host disease (cGVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Bronchiolitis obliterans syndrome (BOS) after allo-HSCT was a clinical syndrome characterized by persistent airflow restriction which is the result of lung cGVHD. BOS is one of the main causes of late mortality after allo-HSCT, severely restricting the daily activities and respiratory function of patients. It limits the quality of life and increased the non-relapse mortality (NRM) after allo-HSCT. Currently, the first-line treatment for BOS is FAM ( oral fluticasone, azithromycin and montelukast). However, more than 50% of patients develop as steroids resistant (SR)-BOS, and SR-BOS has a poor prognosis and irreversible impaired lung function. Ruxolitinib is an effective drug in the treatment of SR-cGVHD. This is a phase Ⅱ prospective clinical study to explore the efficacy and safety of ruxolitinib as a first-line treatment for newly diagnosed BOS after allo-HSCT.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bronchiolitis Obliterans Syndrome | — | UNRESOLVED | — |
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ruxolitinib | Drug | Ruxolitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment group
- description
- Ruxolitinib twice daily treatment, combined with steroids 1mg/kg/day for two weeks, and tampering 0.25 mg/kg/day every week
- interventionNames
- Drug: Ruxolitinib
Primary outcomes (1)
- measure
- absolute FEV1 increase
- timeFrame
- 3 Months
- description
- The proportion of participants with a sustained, absolute FEV1 increase by ≥ 10% after 3 months of treatment with ruxolitinib (compared to baseline measure prior to study enrollment)
Secondary outcomes (7)
- measure
- treatment failure rate
- timeFrame
- 3 Months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female; 18-65 years old 2. Diagnosis of BOS after allo-HCT defined as the 2014 NIH criteria 3. Life expectancy \> 6 months at the time of enrollment 4. At least 4 weeks since initiation of the most recent systemic therapy for cGVHD or BOS 5. The ability to understand and willingness to sign a written consent document Exclusion Criteria: 1. Recurrent malignancy or disease progression requiring anticancer therapy 2. Currently receiving or have previously received ruxolitinib for chronic GVHD therapy 3. Known history of allergy to ruxolitinib or its excipients 4. Hepatic dysfunction: transaminases (ALT, AST) \> 5X ULN and/or total bilirubin \> 3X ULN 5. Hematologic dysfunction: absolute neutrophil count \<1000/μL, platelet cout \<30\*10E9/L, and/or Hgb \< 8 g/dL 6. Renal dysfunction: calculated creatinine clearance \< 30 mL/min (Cockcroft-Gault formula) 7. previously received second-line treatment or any drugs in clinical trials for cGVHD
References
Publications (1)
- DERIVEDBos S, Murray J, Marchetti M, Cheng GS, Bergeron A, Wolff D, Sander C, Sharma A, Badawy SM, Peric Z, Piekarska A, Pidala J, Raj K, Penack O, Kulkarni S, Beestrum M, Linke A, Rutter M, Coleman C, Tonia T, Schoemans H, Stolz D, Vos R. ERS/EBMT clinical practice guidelines on treatment of pulmonary chronic graft-versus-host disease in adults. Eur Respir J. 2024 Mar 28;63(3):2301727. doi: 10.1183/13993003.01727-2023. Print 2024 Mar. PMID 38485149