Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT06976918
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-16
First Post:
2025-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Registry Platform Myelofibrosis and Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055728', 'term': 'Primary Myelofibrosis'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2031-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-09', 'studyFirstSubmitDate': '2025-04-29', 'studyFirstSubmitQcDate': '2025-05-09', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Documentation of systemic treatment for MF and therapy sequences', 'timeFrame': '3 years per patient', 'description': 'Types and frequencies of systemic treatment for MF during observation time.'}], 'secondaryOutcomes': [{'measure': 'Hematologic response', 'timeFrame': '3 years per patient', 'description': 'Frequencies of hematologic response (improved, stable, worsened) per line of treatment'}, {'measure': 'Splenic response', 'timeFrame': '3 years per patient', 'description': 'Frequencies of splenic response (improved, stable, worsened) per line of treatment'}, {'measure': 'Overall response rate (ORR)', 'timeFrame': '3 years per patient', 'description': 'Documentation of ORR per line of treatment'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': '3 years per patient', 'description': 'Documentation of PFS per line of treatment'}, {'measure': 'Overall survival', 'timeFrame': '3 years per patient', 'description': 'Documentation of OS per line of treatment'}, {'measure': 'Health-related quality of life (Patient-reported outcome, PRO)', 'timeFrame': '3 years per patient', 'description': 'European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (EORTC QLQ-C30, the lower the score the better the QoL)'}, {'measure': 'Assessment of Myelofibrosis-related symptoms', 'timeFrame': '3 years per patient', 'description': 'Myelofibrosis Symptom Assessment form (MFSAF) questionnaire 7-day Recall'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Myelofibrosis', 'Secondary Myelofibrosis', 'Post-polycythemia Vera Myelofibrosis', 'Post-essential Thrombocythemia Myelofibrosis', 'Anemia', 'Myelofibrosis; Anemia', 'Myelofibrosis']}, 'descriptionModule': {'briefSummary': 'The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease and to collect patient-reported outcomes for patients with primary and secondary myelofibrosis and anemia in Germany.', 'detailedDescription': 'RHODOLITE is a national, prospective, open-label, longitudinal, non-interventional multicenter cohort study (tumour registry platform) to describe treatment in routine clinical practice of myelofibrosis patients in routine care in Germany.\n\nThe registry will follow patients for up to three years with the aim to identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments and outcome are documented.\n\nHealth-related quality of life (HRQoL) will be evaluated for up to three years.\n\nThe RHODOLITE clinical registry is a joint project with the German Study Group for Myeloproliferative Neoplasms (GSG-MPN) and its GSG-MPN Bioregistry (NCT03125707). Details on treatment and outcome will be collected in RHODOLITE clinical registry for up to three years, while long-term follow-up for a minimum of additional five years will be performed in the GSG-MPN Bioregistry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with primary myelofibrosis or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (MF) with anemia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) (Note: diagnosis according to WHO-2017, ICC-2022 or WHO-2022 or IWG-MRT criteria, respectively).\n* Diagnosis of anemia at the time of enrollment as per individual, clinical assessment by the local physician.\n* Start of first or subsequent systemic treatment for MF.\n* Informed consent and registration for the GSG-MPN Bioregistry.\n* Willingness and capability to participate in PRO assessment.\n* Signed and dated informed consent form for RHODOLITE at the latest six weeks after start of the respective systemic MF treatment.\n\nExclusion Criteria:\n\n* No systemic therapy for diagnosed primary or secondary MF.\n* Planned allogenic stem cell transplantation (allo-SCT) or active participation in an interventional clinical trial.'}, 'identificationModule': {'nctId': 'NCT06976918', 'acronym': 'RHODOLITE', 'briefTitle': 'Registry Platform Myelofibrosis and Anemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'iOMEDICO AG'}, 'officialTitle': 'Clinical Research Platform on Treatment, Quality of Life and Outcome of Patients With Primary and Secondary Myelofibrosis and Anemia Who Are JAK Inhibitor Treatment-naïve or JAK Inhibitor Treatment-experienced (RHODOLITE)', 'orgStudyIdInfo': {'id': 'iOM-110507'}}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Germany', 'facility': 'Multiple sites all over Germany'}], 'centralContacts': [{'name': 'iOMEDICO AG', 'role': 'CONTACT', 'email': 'info@iomedico.com', 'phone': '+4976115242', 'phoneExt': '0'}], 'overallOfficials': [{'name': 'Konstanze Döhner, Prof. Dr. med.', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Ulm, Germany'}, {'name': 'Steffen Koschmieder, Prof. Dr. med.', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Aachen, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'iOMEDICO AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'German Study Group for Myeloproliferative Neoplasms (GSG-MPN)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}