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NCT05413356
Ruxolitinib for Newly Diagnosed Bronchiolitis Obliterans Syndrome
Phase 2 trial testing Ruxolitinib in Bronchiolitis Obliterans Syndrome in 50 participants. Status unknown.
1 June 2024
Quick facts
| Lead sponsor | First Affiliated Hospital of Zhejiang University |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 1 June 2022 |
| Primary completion | 1 June 2024 |
| Estimated completion | 1 January 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Ruxolitinib (RUXOLITINIB) — full drug profile →
Conditions studied
- Bronchiolitis Obliterans Syndrome — all drugs for Bronchiolitis Obliterans Syndrome →
- Hematologic Malignancy — all drugs for Hematologic Malignancy →
Sponsor
First Affiliated Hospital of Zhejiang University
Who can join
Adults 18 to 65, any sex, with Bronchiolitis Obliterans Syndrome or Hematologic Malignancy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
JAK/STAT pathway: Extracellular signals, diseases, immunity, and therapeutic regimens.
Hu Q, Bian Q, Rong D, Wang L, et al · · 2023 · cited 190× · PMID 36911202 · DOI 10.3389/fbioe.2023.1110765 -
Chronic Graft-versus-host Disease, Part 2: Clinical Success and Roadmap to the Future.
El Jurdi N, Blazar BR, Pavletic SZ. · · 2025 · cited 2× · PMID 39915926 · DOI 10.1097/tp.0000000000005345
Verify or expand the search:
- PubMed search for NCT05413356
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ruxolitinib
Trials testing the same drug.
- NCT07498205 — Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Counts · Phase 4 · not yet recruiting
- NCT07249346 — Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease ( · Phase 2 · recruiting
- NCT07311746 — Phase Ib/II Trial of Cladribine/Ruxolitinib/Venetoclax in Patients With Relapsed/Refractory T-cell Prolymphocytic Leukem · Phase 1, PHASE2 · not yet recruiting
- NCT07340138 — Study of Pelabresib add-on to Ruxolitinib in Japanese Adult Patients With Myelofibrosis · Phase 1 · not yet recruiting
- NCT07424222 — Ruxolitinib for Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (RISE) · Phase 1 · not yet recruiting
Other recruiting trials for Bronchiolitis Obliterans Syndrome
Currently open trials in the same condition.
- NCT05922761 — BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP) · Phase 2 · recruiting
- NCT05250037 — The Longitudinal Impact of Respiratory Viruses on Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Cell · recruiting
- NCT04391335 — Novel Pulmonary Function Measures for Diagnosis of Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem-Cell T · recruiting
- NCT02669251 — Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hemato · Phase 1, PHASE2 · active not recruiting
Other First Affiliated Hospital of Zhejiang University trials
Trials by the same sponsor.
- NCT07537192 — Inulin-Spirulina Co-intervention for Insomnia Disorder · NA · not yet recruiting
- NCT07510867 — 18F-FAPI PET/CT and MRI in Gastric Cancer · not yet recruiting
- NCT07589647 — Research on the Efficacy and Safety of Targeted Suprachiasmatic Nucleus Electrical Stimulation for Improving Metabolic D · NA · recruiting
- NCT07525765 — AI-assisted Decision-making of Reoperation for Postoperative Bleeding of Gastric Cancer · recruiting
- NCT07468162 — Characteristic Electroencephalogram of General Anesthesia · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05413356 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by First Affiliated Hospital of Zhejiang University
- Last refreshed: 19 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05413356.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing