Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-28 @ 7:50 PM
Study NCT ID:
NCT00437450
Status:
UNKNOWN
Last Update Posted:
2009-11-18
First Post:
2007-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 99}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-02', 'completionDateStruct': {'date': '2005-09'}, 'lastUpdateSubmitDate': '2009-11-17', 'studyFirstSubmitDate': '2007-02-19', 'studyFirstSubmitQcDate': '2007-02-19', 'lastUpdatePostDateStruct': {'date': '2009-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the efficacy of association of Erythropoetin and ATRA in patients with low risk myelodysplastic syndromes'}], 'secondaryOutcomes': [{'measure': 'To evaluate the tolerance of this treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anemia', 'myelodysplastic syndromes', 'Low risk', 'Bone Marrow diseases'], 'conditions': ['Anemia in Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is\n\n* To evaluate the efficacy of association of Erythropoetin (Neorecormon) and ATRA in patients with low risk myelodysplastic syndromes\n* To evaluate the tolerance of this treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥18 years with RA, RARS, RAEB (blasts \\<10%)\n* Hb\\< 10g/dl \\> of 2 months or transfused since less 2 months\n* Hb\\<12g/dl \\> of 2 months and thrombocytopenia defined by platelets \\< 50 000/mm3, or neutropenia\\<10 000mm3\n* For women of child bearing age, necessity of contraception during all the duration of the study\n\nExclusion Criteria:\n\n* Patient with lung disease, cardiac, neurological, gastro-intestinal or genito - urinary disorders not connected to genito -urinary not connected to myelodysplasia\n* Patient having received intensive chemotherapy in the 3 months before inclusion in the protocol\n* RAEBt\n* RAEB \\>10% blasts\n* Treatment with rHu-Epo, darbepoetin ou rHu-GCSF , 2 months before inclusion\n* Patient presenting an iron , B12 vitamin or folic acid uncorrected deficit\n* CMML\n* Uncontrolled systemic hypertension\n* creatinine clearance \\< 300 µM/L\n* Pregnant patient or in period of lactation\n* Life expectancy \\< 6 months'}, 'identificationModule': {'nctId': 'NCT00437450', 'briefTitle': 'Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Francophone des Myelodysplasies'}, 'officialTitle': 'Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid', 'orgStudyIdInfo': {'id': '040759'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Epoetin/Atra', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '84054', 'city': 'Amiens', 'country': 'France', 'facility': "CHU d'Amiens", 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '43033', 'city': 'Angers', 'country': 'France', 'facility': "CHU d'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '84000', 'city': 'Avignon', 'country': 'France', 'facility': "CHU d'Avignon", 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '64100', 'city': 'Bayonne', 'country': 'France', 'facility': 'CH de la cote Basque', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '93009', 'city': 'Bobigny', 'country': 'France', 'facility': 'Hopital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'CHU de Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '92140', 'city': 'Clamart', 'country': 'France', 'facility': 'Hopital Percy', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'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': 'CHRU Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69437', 'city': 'Lyon', 'country': 'France', 'facility': 'CHU Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13009', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut 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': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Necker', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'HOPITAL Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75181', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Hotel Dieu', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '29107', 'city': 'Quimper', 'country': 'France', 'facility': 'CH de Cournouaille', 'geoPoint': {'lat': 47.99597, 'lon': -4.09795}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'CHU Robert Debre', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '76038', 'city': 'Rouen', 'country': 'France', 'facility': 'Hopital Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Hopital Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Chu Purpan', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'CHU Bretoneau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'CHU Brabois', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'Lionel ADES, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Groupe Francophone des Myelodysplasies'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Francophone des Myelodysplasies', 'class': 'OTHER'}}}}