Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-02-25 @ 4:59 PM
Study NCT ID:
NCT02910258
Status:
COMPLETED
Last Update Posted:
2018-09-21
First Post:
2016-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interferon-pegyle α2a Efficiency and Tolerance 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-20', 'studyFirstSubmitDate': '2016-08-26', 'studyFirstSubmitQcDate': '2016-09-19', 'lastUpdatePostDateStruct': {'date': '2018-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficiency of the interferon in Myelofibrosis', 'timeFrame': 'Evaluation at 1 year', 'description': 'Evaluation on the presence or not of splenomegaly and physical signs or the normalization of blood counts.'}], 'secondaryOutcomes': [{'measure': 'Rate of survival of patients with Myelofibrosis under interferon', 'timeFrame': 'Evaluation at 5 years', 'description': 'Patients dead or alive at this time'}, {'measure': 'Tolerance of Interferon', 'timeFrame': 'Evaluation at 1 year', 'description': 'Presence or not of psychiatric symptoms, cramps, hepatitic abnormalities'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['myelofibrosis', 'pegylated interferon'], 'conditions': ['Myelofibrosis']}, 'referencesModule': {'references': [{'pmid': '29217781', 'type': 'RESULT', 'citation': 'Ianotto JC, Chauveau A, Boyer-Perrard F, Gyan E, Laribi K, Cony-Makhoul P, Demory JL, de Renzis B, Dosquet C, Rey J, Roy L, Dupriez B, Knoops L, Legros L, Malou M, Hutin P, Ranta D, Benbrahim O, Ugo V, Lippert E, Kiladjian JJ. Benefits and pitfalls of pegylated interferon-alpha2a therapy in patients with myeloproliferative neoplasm-associated myelofibrosis: a French Intergroup of Myeloproliferative neoplasms (FIM) study. Haematologica. 2018 Mar;103(3):438-446. doi: 10.3324/haematol.2017.181297. Epub 2017 Dec 7.'}]}, 'descriptionModule': {'briefSummary': 'Patients who carried primary or secondary myelofibrosis from Philadelphia negative MPNs (PMF/SMF) and who are treated or are about to be treated with pegylated-interferon (mostly α2a) are eligible to this prospective study. Biological and clinical parameters will be collected from the beginning of the drug use until last news.\n\nA non-opposition consent form need to be signed before entering this study.', 'detailedDescription': 'In all centres interested, patients who were diagnosed for PMF/SMF can be treated with oral or sub-cutaneous drugs in order to reduce clinical symptoms and biological abnormalities belonging to these diseases.\n\nPegylated-interferon is one of the better weapons that can be used in these cases. These treatments are well known and used from many years in french hematological centres.\n\nThe investigators to collect clinical and biological data from patients treated with pegylated-interferon α2a (the most use) in case of PMF/SMF in order to assess efficacity and tolerance to this drug. The prescription of the product and the dose are under the responsibility of each practician.\n\nClinical data collected: disease and patients characteristics at the time of diagnosis and at the beginning of the drug use, spleen and liver size, presence of constitutive symptoms, transfusion needs.\n\nBiological data collected: complete hemogram, CD34+ cells count, allele burden of JAK2V617F and calreticulin clones if DNA samples are collected.\n\nThese data will be collected avery 3 months during the two first years and every 6 months after.\n\nThe investigators also recorded adverse side effects if significative, the concomitant use of hematological drugs (cytoreductive treatments, ASE...), modalities of prescription of the drugs and the reason for stopping the drug and etiology of death if happened.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed for PMF or SMF and treated with pegykated interferon α2a', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary or secondary Myelofibrosis\n* Prescription of pegylated interferon α2a\n* Age \\> 18 years-old\n\nExclusion Criteria:\n\n* Other MPNs treated with pegylated interferon α2a\n* Patients treated for PMF or SMF but without pegylated interferon'}, 'identificationModule': {'nctId': 'NCT02910258', 'acronym': 'PEG-MF', 'briefTitle': 'Interferon-pegyle α2a Efficiency and Tolerance in Myelofibrosis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': "Etude de l'efficacité et de la tolérance de l'interféron-pégylé Dans Les myélofibroses", 'orgStudyIdInfo': {'id': 'PEG-MF'}}, 'contactsLocationsModule': {'locations': [{'zip': '49000', 'city': 'Angers', 'country': 'France', 'facility': "CHU d'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Annecy', 'country': 'France', 'facility': 'Hopital du genevois', 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Le Mans', 'country': 'France', 'facility': 'Centre Hospitalier du Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'city': 'Lens', 'country': 'France', 'facility': 'Centre Hospitalier de Lens', 'geoPoint': {'lat': 50.43302, 'lon': 2.82791}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli Calmette', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '29672', 'city': 'Morlaix', 'country': 'France', 'facility': 'CH des pays de Morlaix', 'geoPoint': {'lat': 48.57784, 'lon': -3.82792}}, {'city': 'Nice', 'country': 'France', 'facility': 'Centre Hospitalier de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'AP-HP Hôpital Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '29000', 'city': 'Quimper', 'country': 'France', 'facility': 'CHIC de Cornouaille', 'geoPoint': {'lat': 47.99597, 'lon': -4.09795}}, {'city': 'Tours', 'country': 'France', 'facility': 'Centre Hospitalier de Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'CHU de Nancy', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'Jean-Christophe Ianotto, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHRU de Brest'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}