Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 12:28 AM
Study NCT ID:
NCT00235560
Status:
COMPLETED
Last Update Posted:
2024-02-29
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rapamycin in Combination With Low-dose Aracytin in Elderly Acute Myeloid Leukemia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020123', 'term': 'Sirolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-27', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-10-06', 'lastUpdatePostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'response rate'}], 'secondaryOutcomes': [{'measure': 'tolerability'}, {'measure': 'bioclinical markers of response'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AML', 'Rapamycin', 'Elderly', 'Elderly patients not eligible for intensive chemotherapy'], 'conditions': ['Acute Myeloid Leukemia']}, 'referencesModule': {'references': [{'pmid': '15550488', 'type': 'BACKGROUND', 'citation': 'Recher C, Beyne-Rauzy O, Demur C, Chicanne G, Dos Santos C, Mas VM, Benzaquen D, Laurent G, Huguet F, Payrastre B. Antileukemic activity of rapamycin in acute myeloid leukemia. Blood. 2005 Mar 15;105(6):2527-34. doi: 10.1182/blood-2004-06-2494. Epub 2004 Nov 18.'}]}, 'descriptionModule': {'briefSummary': 'These study is designed to evaluate the tolerability and efficacy of sirolimus (rapamycin) in combination with low-dose aracytin in elderly AML.', 'detailedDescription': 'Evaluate the tolerability and efficacy of sirolimus (rapamycin) in combination with low-dose aracytin'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* de novo or secondary LAM (CML excluded) not elligible for intensive chemotherapy.\n* Previously untreated\n\nExclusion Criteria:\n\n* Renal impairment (serum creatinin \\>2N)\n* Hepatic impairment (TGO ou TGP \\> 5N), une cholestase (Phosphatases Alcalines or gamma-GT \\> 5N),bilirubin \\> 3N\n\n * Blast crisis CML\n * Acute Promyelocytic Leukemia.'}, 'identificationModule': {'nctId': 'NCT00235560', 'acronym': 'LAM-RAPA', 'briefTitle': 'Rapamycin in Combination With Low-dose Aracytin in Elderly Acute Myeloid Leukemia Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': "Rapamycin in Combination With Low-dose Aracytin in Elderly Acute Myeloid Leukemia Patients. A Study From the Groupe Ouest Est d'étude Des Leucémies Aiguës Myéloïdes (GOELAMS)", 'orgStudyIdInfo': {'id': '0402008'}, 'secondaryIdInfos': [{'id': 'GOELAMS'}, {'id': 'PHRC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rapamycine', 'interventionNames': ['Drug: rapamycin']}], 'interventions': [{'name': 'rapamycin', 'type': 'DRUG', 'otherNames': ['RAPAMUNE'], 'description': 'sirolimus', 'armGroupLabels': ['Rapamycine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49100', 'city': 'Angers', 'country': 'France', 'facility': "Service d'Hématologie, CHU", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': "Service d'Hématologie, Hôpital Jean Minjoz", 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': "Service d'Hématologie CHU Purpan", 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'RECHER Christian', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'collaborators': [{'name': 'French Innovative Leukemia Organisation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}