Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-01 @ 8:22 AM
Study NCT ID:
NCT05413356
Status:
UNKNOWN
Last Update Posted:
2022-10-19
First Post:
2022-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ruxolitinib for Newly Diagnosed Bronchiolitis Obliterans Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C540383', 'term': 'ruxolitinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-18', 'studyFirstSubmitDate': '2022-06-07', 'studyFirstSubmitQcDate': '2022-06-07', 'lastUpdatePostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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)'}], 'secondaryOutcomes': [{'measure': 'treatment failure rate', 'timeFrame': '3 Months', 'description': '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)'}, {'measure': 'absolute FEV1 increase', 'timeFrame': '6 Months, 9 Months, 12 Months and 24 Months', 'description': 'The proportion of participants with a sustained, absolute FEV1 increase by ≥ 10% after treatment with ruxolitinib (compared to baseline measure prior to study enrollment)'}, {'measure': 'Improvements in chronic GVHD organ specific manifestations', 'timeFrame': '6 Months, 9 Months, 12 Months and 24 Months', 'description': 'mprovements in chronic GVHD organ specific manifestations will be categorized according to the NIH chronic GVHD consensus criteria.'}, {'measure': 'Overall Survival', 'timeFrame': '2 years', 'description': 'The proportion of patients survival at two years after enrollment of ruxolitinib treatment'}, {'measure': 'cGVHD progression-free survival', 'timeFrame': '2 years', 'description': 'Participants alive without cGVHD progression are censored at the date of last disease evaluation'}, {'measure': 'The incidence and types of serious adverse events', 'timeFrame': 'From the start of treatment until 30 days after the end of treatment, up to 2 years', 'description': 'Adverse events are graded according to Common Terminology Criteria for Adverse Events (CTCAE v4)'}, {'measure': 'The change of systemic corticosteroid dose over time', 'timeFrame': 'From the start of treatment until the end of treatment, up to 2 years', 'description': 'The change of systemic corticosteroid dose over time during the treatment of BOS'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Allogeneic Hematopoietic stem cell transplantation', 'chronic graft versus host disease', 'bronchiolitis obliterans syndrome'], 'conditions': ['Bronchiolitis Obliterans Syndrome', 'Hematologic Malignancy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female; 18-65 years old\n2. Diagnosis of BOS after allo-HCT defined as the 2014 NIH criteria\n3. Life expectancy \\> 6 months at the time of enrollment\n4. At least 4 weeks since initiation of the most recent systemic therapy for cGVHD or BOS\n5. The ability to understand and willingness to sign a written consent document\n\nExclusion Criteria:\n\n1. Recurrent malignancy or disease progression requiring anticancer therapy\n2. Currently receiving or have previously received ruxolitinib for chronic GVHD therapy\n3. Known history of allergy to ruxolitinib or its excipients\n4. Hepatic dysfunction: transaminases (ALT, AST) \\> 5X ULN and/or total bilirubin \\> 3X ULN\n5. Hematologic dysfunction: absolute neutrophil count \\<1000/μL, platelet cout \\<30\\*10E9/L, and/or Hgb \\< 8 g/dL\n6. Renal dysfunction: calculated creatinine clearance \\< 30 mL/min (Cockcroft-Gault formula)\n7. previously received second-line treatment or any drugs in clinical trials for cGVHD'}, 'identificationModule': {'nctId': 'NCT05413356', 'briefTitle': 'Ruxolitinib for Newly Diagnosed Bronchiolitis Obliterans Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Zhejiang University'}, 'officialTitle': 'Ruxolitinib for Newly Diagnosed Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': 'ZJU-HSCT-BOS'}}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'Ruxolitinib', 'type': 'DRUG', 'otherNames': ['Ruxolitinib twice daily'], 'description': 'Oral ruxolitinib twice daily', 'armGroupLabels': ['treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi Luo, M.D.', 'role': 'CONTACT', 'email': 'luoyijr@163.com', 'phone': '+86057187233801'}], 'facility': 'The first Affiliated Hospital of Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Yi Luo, M.D.', 'role': 'CONTACT', 'email': 'luoyijr@163.com', 'phone': '+86057187233801'}, {'name': 'Yibo Wu, M.D.', 'role': 'CONTACT', 'email': 'wuyibo7@126.com', 'phone': '+8619858876273'}], 'overallOfficials': [{'name': 'Yi Luo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affilaated Hospital of Medical School of Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, {'name': "Zhejiang Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Zhejiang Chinese Medical University', 'class': 'OTHER'}, {'name': 'Sir Run Run Shaw Hospital', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, {'name': 'Ningbo No. 1 Hospital', 'class': 'OTHER'}, {'name': "The Affiliated People's Hospital of Ningbo University", 'class': 'OTHER_GOV'}, {'name': 'Jinhua Central Hospital', 'class': 'OTHER'}, {'name': 'Taizhou Hospital', 'class': 'OTHER'}, {'name': 'Union hospital of Fujian Medical University', 'class': 'OTHER'}, {'name': 'Xiangya Hospital of Central South University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}