Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-02-25 @ 6:55 PM
Study NCT ID:
NCT01794169
Status:
TERMINATED
Last Update Posted:
2015-09-22
First Post:
2013-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Azacitidine Compared to Conventional Chemotherapy as Consolidation of Elderly Patients With AML
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': 'D001374', 'term': 'Azacitidine'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D003561', 'term': 'Cytarabine'}], 'ancestors': [{'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'whyStopped': 'Poor recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-19', 'studyFirstSubmitDate': '2013-02-13', 'studyFirstSubmitQcDate': '2013-02-14', 'lastUpdatePostDateStruct': {'date': '2015-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Molecular analyses', 'timeFrame': 'Two years', 'description': 'Analysis of a broad spectrum of molecular and cellular events relating to the epigenetic status of the malignant cells. These events will be used to identify biomarkers for successful consolidation and to address whether AML cases that relapse while on the study are molecularly and epigenetically different between those given azacitidine or DA consolidation'}, {'measure': 'Leukemia free survival (LFS)', 'timeFrame': 'One year', 'description': 'Analysis whether cytogenetic and molecular aberrations at diagnosis will predict for better LFS with either Azacitidine or standard DA consolidation.'}], 'primaryOutcomes': [{'measure': 'Leukemia free survival', 'timeFrame': 'One year'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Two years'}, {'measure': 'Treatment related morbidity and mortality', 'timeFrame': 'Two years'}, {'measure': 'Severe Adverse Events (SAE)', 'timeFrame': 'Two months after the last course of consolidation', 'description': 'SAE as defined by CTCAE'}, {'measure': 'Number of days admitted in hospital', 'timeFrame': '12 months from start of consolidation treatment'}, {'measure': 'Quality of life', 'timeFrame': 'Until 24 months from start of consolidation treatment', 'description': 'EORTC QLQ C30'}, {'measure': 'Number of participants with AE grade 3 or more', 'timeFrame': 'Until two months after the last course of consolidation', 'description': 'AE:s graded according to CTCAE'}, {'measure': 'Number of consolidation courses actually given within the study', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Azacitidine consolidation is superior to standard DA consolidation treatment of acute myeloid leukemia in first complete remission in elderly patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects \\>65 years of age at the time of signing the informed consent form\n2. A confirmed diagnosis of AML according to the 2008 WHO classification\n\n * This includes: Bone marrow aspirate with a good clot or biopsy for morphology, flow cytometry, cytogenetic analysis, and in case of normal cytogenetics, molecular genetic analyses including FLT3-ITD, NPM-1 and CEBP A\n * Bio-banking of leukemic cells at diagnosis performed (according to guidelines of the Swedish National AML biobank).\n3. A documented CR or CRp achieved after one or two induction courses.\n\nExclusion Criteria:\n\n1. Subjects who are not considered to be candidates to complete the consolidation therapy due to medical or psychological reasons.\n2. Subjects who have taken any investigational drugs or participated in an interventional clinical trial within 30 days prior to screening.\n3. Patients with acute promyelocytic leukemia\n4. Patients with t(8;21) or inv(16)\n5. CNS leukemia\n6. Patients with a previous diagnosis of MDS, i.e. AML preceded by a diagnosed MDS\n7. Subjects who are candidates for allogeneic stem cell transplantation (SCT)\n8. Another cancer diagnosis with a life expectancy of less than two years'}, 'identificationModule': {'nctId': 'NCT01794169', 'briefTitle': 'Azacitidine Compared to Conventional Chemotherapy as Consolidation of Elderly Patients With AML', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Azacitidine Compared to Conventional Chemotherapy in Consolidation of Elderly Patients (65 Years or Older) With AML in First Complete Remission', 'orgStudyIdInfo': {'id': 'SWEAML12-a'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Azacitidine', 'description': 'Azacitidine 75mg/m2/d subcutaneously once daily for 5 days given every 5:th week for 8 cycles.', 'interventionNames': ['Drug: Azacitidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DA', 'description': 'Two courses of DA in accordance with the Swedish National treatment program (reduced doses):\n\nIn case one induction course was given:\n\nFirst consolidation course: daunorubicin 45 mg/m2 x 1 (iv infusion) day 1-3 and cytarabine 1000 mg/m2 x 2 (iv infusion) day 1-4.\n\nSecond consolidation course: daunorubicin 45 mg/m2 x 1( iv infusion) day 1-2 and cytarabine 200 mg x 2 (fixed dose sc injection) day 1- 5.\n\nIn case two induction courses were given:\n\nFirst consolidation course: daunorubicin 45 mg/m2 x 1( iv infusion) day 1-2 and cytarabine 200 mg x 2 (fixed dose sc injection) day 1- 5.\n\nSecond consolidation course: cytarabine 200mg x 2 (fixed dose sc injection) day 1-5.', 'interventionNames': ['Drug: DA']}], 'interventions': [{'name': 'Azacitidine', 'type': 'DRUG', 'otherNames': ['Vidaza'], 'armGroupLabels': ['Azacitidine']}, {'name': 'DA', 'type': 'DRUG', 'otherNames': ['Daunorubicin', 'Cytarabine', 'Ara-C'], 'armGroupLabels': ['DA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17176', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital, Solna', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Per Bernell, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska University Hospital'}, {'name': 'Stefan Deneberg, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Celgene Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D, Ph.D.', 'investigatorFullName': 'Stefan Deneberg', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}