Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 4:20 PM
Study NCT ID:
NCT05447260
Status:
UNKNOWN
Last Update Posted:
2022-07-07
First Post:
2022-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A New Prognostic Stratification-based Safety and Efficacy Study of Ruxolitinib in Myelofibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055728', 'term': 'Primary Myelofibrosis'}], 'ancestors': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C540383', 'term': 'ruxolitinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 87}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-03', 'studyFirstSubmitDate': '2022-07-03', 'studyFirstSubmitQcDate': '2022-07-03', 'lastUpdatePostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of patients with a ≥35% reduction in palpable spleen volume from baseline.', 'timeFrame': 'From Week 0 through Week 24', 'description': 'Reduction in spleen volume is measured by magnetic resonance imaging/computerized tomography (MRI/CT).'}], 'secondaryOutcomes': [{'measure': 'The proportion of patients with ≥50% reduction in Total Symptom Score (TSS) from baseline.', 'timeFrame': 'From Week 0 through Week 24', 'description': 'TSS is assessed by the MPN-10.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myelofibrosis']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, prospective, single-arm study to assess safety and efficacy of Ruxolitinib in myelofibrosis (MF) based on a new prognostic stratification.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female patients aged ≥18 years with a diagnosis of primary or secondary MF by World Health Organization and International Working Group for Myeloproliferative Neoplasms Research and Treat- ment (IWG-MRT) criteria;\n2. Received ruxolitinib treatment for ≥3 months.\n\nExclusion Criteria:\n\n1. Malignant tumors with other progression or myelofibrosis secondary to other diseases;\n2. Exclude myelofibrosis patients after splenectomy;\n3. Patients with poor compliance with case follow-up or lost to follow-up.'}, 'identificationModule': {'nctId': 'NCT05447260', 'briefTitle': 'A New Prognostic Stratification-based Safety and Efficacy Study of Ruxolitinib in Myelofibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'A New Prognostic Stratification-based Safety and Efficacy Study of Ruxolitinib in Myelofibrosis: a Multicenter, Prospective, Single-arm Clinical Study', 'orgStudyIdInfo': {'id': 'MIPSS70+2.0 MF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ruxolitinib', 'interventionNames': ['Drug: Ruxolitinib']}], 'interventions': [{'name': 'Ruxolitinib', 'type': 'DRUG', 'description': 'Dosage based on platelet count', 'armGroupLabels': ['Ruxolitinib']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chen', 'role': 'CONTACT', 'email': 'chency@sdu.edu.cn'}], 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Chen', 'role': 'CONTACT', 'email': 'chency@sdu.edu.cn', 'phone': '18560087023'}, {'name': 'Yu', 'role': 'CONTACT', 'email': 'yuyuandoctor@163.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}