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| Name | Class |
|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
| Zhejiang Provincial People's Hospital | OTHER |
| The First Affiliated Hospital of Zhejiang Chinese Medical University | OTHER |
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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.
The incidence of chronic graft versus host disease (cGVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT) was 30%-70%, Which extremely limited the quality of life and the survival of patients after allo-HSCT. Lung is one of the target organs in cGVHD after 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | Ruxolitinib twice daily treatment, combined with steroids 1mg/kg/day for two weeks, and tampering 0.25 mg/kg/day every week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib | Drug | Oral ruxolitinib twice daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| absolute FEV1 increase | 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) | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| treatment failure rate | The proportion of participants who do not experience a sustained, absolute decrease in FEV1 by ≥ 10% after 3 months of treatment with ruxolitinib (compared to baseline measure prior to study enrollment) | 3 Months |
| absolute FEV1 increase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Luo, M.D. | Contact | +86057187233801 | luoyijr@163.com | |
| Yibo Wu, M.D. | Contact | +8619858876273 | wuyibo7@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Luo, M.D. | First Affilaated Hospital of Medical School of Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first Affiliated Hospital of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38485149 | Derived | Bos 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. |
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| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
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| Sir Run Run Shaw Hospital | OTHER |
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
| Ningbo No. 1 Hospital | OTHER |
| The Affiliated People's Hospital of Ningbo University | OTHER_GOV |
| Jinhua Central Hospital | OTHER |
| Taizhou Hospital | OTHER |
| Union hospital of Fujian Medical University | OTHER |
| Xiangya Hospital of Central South University | OTHER |
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The proportion of participants with a sustained, absolute FEV1 increase by ≥ 10% after treatment with ruxolitinib (compared to baseline measure prior to study enrollment) |
| 6 Months, 9 Months, 12 Months and 24 Months |
| Improvements in chronic GVHD organ specific manifestations | mprovements in chronic GVHD organ specific manifestations will be categorized according to the NIH chronic GVHD consensus criteria. | 6 Months, 9 Months, 12 Months and 24 Months |
| Overall Survival | The proportion of patients survival at two years after enrollment of ruxolitinib treatment | 2 years |
| cGVHD progression-free survival | Participants alive without cGVHD progression are censored at the date of last disease evaluation | 2 years |
| The incidence and types of serious adverse events | Adverse events are graded according to Common Terminology Criteria for Adverse Events (CTCAE v4) | From the start of treatment until 30 days after the end of treatment, up to 2 years |
| The change of systemic corticosteroid dose over time | The change of systemic corticosteroid dose over time during the treatment of BOS | From the start of treatment until the end of treatment, up to 2 years |
| D001982 |
| Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |