Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2026-03-06 @ 1:33 AM
Study NCT ID:
NCT00411905
Status:
COMPLETED
Last Update Posted:
2025-01-07
First Post:
2006-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bortezomib and Low Dose Cytarabine in the Treatment of High-risk Myelodysplastic Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069286', 'term': 'Bortezomib'}], 'ancestors': [{'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Essai ouvert multicentrique de phase I-II'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2011-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2006-12-14', 'studyFirstSubmitQcDate': '2006-12-14', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Response'}, {'measure': 'Partial Response'}, {'measure': 'Efficacy and safety evaluation', 'timeFrame': '18 mois', 'description': 'A total of 138 cycles were administered. The median number of cycles administered was 3·2 (range 0·5-8). Thirty-six patients (84%) received at least two cycles and 17 (40%) received the planned four cycles, six responding patients received 1-4 additional cycles. Treatment was dis- continued in the responding patients at progression to AML or for toxicity.\n\nThe most common treatment-related adverse events were related to myelosuppression . Neutropenia (Grade 4) and thrombocytopenia (Grade 4) were seen during treatment in 51% and 46% of the patients, respectively. Three of the patients with pre-treatment Grade 0-2 neutropenia and thrombocytopenia developed Grade 3-4 toxicity complicated by infection and bleeding. Grade 3-4 neutropenia was responsible for infection in six patients. Grade 3-4'}], 'secondaryOutcomes': [{'measure': 'Hematological Improvement'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myelodysplastic syndromes', 'IPSS Int-2 and High risk', 'Bortezomib', 'Low dose Cytarabine', 'Bone Marrow diseases'], 'conditions': ['Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': 'We are evaluating the efficacy of the association of Low dose Cytarabine in association with Bortezomib in the treatment of patients diagnosed with high risk Myelodysplastic syndromes. Our aim is to decrease transfusion requirements and if possible induce a complete or at least a partial remission.', 'detailedDescription': 'Four cycles of treatment are proposed at 28 day intervals in an ambulatory setting\n\nCycle 1 :\n\n* Cytarabine 10 mg /m2/day subcutaneous injection for 14 days\n* Bortézomib 1,5mg/m2 days 1,4,8,11\n\nCycles 2, 3, 4 :\n\n* Cytarabine 20 mg /m2/j subcutaneous injections for 14 days\n* Bortézomib 1,5mg/m2 days 1,4,8,11\n\nBone marrow aspirates are evaluated just before the first cycle, after the second and after the fourth cycles\n\nResponding patients may continue the treatment for 2 further cycles'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MDS with IPSS scores Int-2 or High\n* Life expectancy greater than 6 months\n* No other available treatment options\n\nExclusion Criteria:\n\n* MDS with IPSS scores Low or Int-1\n* \\> 30% bone marrow blasts\n* clinical neuropathy of greater than grade 2\n* ECOG Score 3 or 4\n* Creatinine clearance of \\< 30 ml/min\n* LMMC\n* Pregnant patients or lactating mothers\n* Patients having received intensive chemotherapy in the 3 months prior to inclusion\n* Patients with uncontrolled pulmonary, cardiac, neurological, gastro-intestinal or genito-urinary disorders'}, 'identificationModule': {'nctId': 'NCT00411905', 'briefTitle': 'Bortezomib and Low Dose Cytarabine in the Treatment of High-risk Myelodysplastic Syndromes', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Francophone des Myelodysplasies'}, 'officialTitle': 'Phase I/II Study of Bortezomib and Low Dose Cytarabine in the Treatment of High-risk Myelodysplastic Syndromes', 'orgStudyIdInfo': {'id': 'GFM BAR-C-2005'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Bortezomib', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '43033', 'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '93009', 'city': 'Bobigny', 'country': 'France', 'facility': 'Hopital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'CHU de Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU Albert Michallon', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '87046', 'city': 'Limoges', 'country': 'France', 'facility': 'CHU de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '13273', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital Paoli Calmette', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'facility': 'CHU Archet', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '66046', 'city': 'Perpignan', 'country': 'France', 'facility': 'Centre Hospitalier Joffre', 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}, {'zip': '76038', 'city': 'Rouen', 'country': 'France', 'facility': 'Centre Henry Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de STRASBOURG', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Purpan', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'CHU Brabois', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'Francois DREYFUS, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Groupe francaise des Myelodysplasies'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Francophone des Myelodysplasies', 'class': 'OTHER'}, 'collaborators': [{'name': 'Johnson & Johnson', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}