Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
Study NCT ID:
NCT03545035
Status:
COMPLETED
Last Update Posted:
2022-05-12
First Post:
2018-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety in Patients With Chronic Lymphocytic Leukemia (CLL) Treated With Idelalisib and Rituximab in the Clinical Practice: a GIMEMA-ERIC Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'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'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552946', 'term': 'idelalisib'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-11', 'studyFirstSubmitDate': '2018-05-22', 'studyFirstSubmitQcDate': '2018-05-22', 'lastUpdatePostDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients responding to treatment', 'timeFrame': 'At 12 months from treatment start', 'description': 'Efficacy profile of idelalisib and rituximab'}, {'measure': 'Number of patients experiencing toxicities', 'timeFrame': 'At 12 months from treatment start', 'description': 'Safety profile of idelalisib and rituximab'}], 'secondaryOutcomes': [{'measure': 'Number of patients alive', 'timeFrame': 'At 12 months from treatment start', 'description': 'Overall survival'}, {'measure': 'Number of patients alive without progression of the disease', 'timeFrame': 'At 12 months from treatment start', 'description': 'Progression-free-survival'}, {'measure': 'Number of patients achieving response', 'timeFrame': 'At 12 months from treatment start', 'description': 'Overall response rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Lymphocytic Leukemia', 'Idelalisib', 'Rituximab'], 'conditions': ['Chronic Lymphocytic Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.gimema.it', 'label': 'GIMEMA Foundation website'}]}, 'descriptionModule': {'briefSummary': 'The present study aims at obtaining more in-depth information on how patients with chronic lymphocytic leukemia treated with idelalisib and rituximab react to treatment.', 'detailedDescription': 'This cohort study will recruit patients with treatment-naïve chronic lymphocytic leukemia (CLL) with TP53 disruption (i.e. 17p- or TP53 mutations) or relapsed/refractory CLL who were treated with idelalisib and rituximab between 01/07/2014 and 31/05/2017 at European centres adhering to the GIMEMA group and the ERIC group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This cohort study will recruit patients with treatment-naïve chronic lymphocytic leukemia (CLL) with TP53 disruption (i.e. 17p- or TP53 mutations) or relapsed/refractory CLL who were treated with idelalisib and rituximab between 01/07/2014 and 31/05/2017 at European centres adhering to the GIMEMA group and the ERIC group.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of CLL / Small Lymphocytic Lymphoma (CLL/SLL) according to the World Health Organisation (WHO) classification 2008.\n* Treatment with idelalisib and rituximab started between the date of Country marketing authorization approval of idelalisib (EMA approval 18/09/2014) and 31/05/2017 given at European centres adhering to the GIMEMA group and the ERIC group.\n* One of the two following conditions must be satisfied:\n\n * Previously untreated CLL requiring therapy according to the NCI criteria (Hallek M et al, Blood 2008)\\] with deletion 17p13 and/or TP53 mutation.\n * Relapsed refractory CLL., i.e. patients who received at least one previous line of treatment using alkylating agents and/or purine analogues with or without monoclonal antibodies, or high dose steroids requiring therapy according to the NCI criteria (Hallek M et al, Blood 2008)\n* Age ≥ 18 years.\n* Signed written informed consent, if applicable, according to ICH/EU/GCP and national local law.\n\nExclusion Criteria:\n\n* Patients with CLL treated with idelalisib within interventional clinical trials or outside the approved indication.\n* Patients with:\n\n * Transformation of CLL to aggressive lymphomas (Richter's Syndrome).\n * HIV infection.\n * Active and uncontrolled HCV and/or HBV infections or liver cirrhosis."}, 'identificationModule': {'nctId': 'NCT03545035', 'acronym': 'LLC178', 'briefTitle': 'Efficacy and Safety in Patients With Chronic Lymphocytic Leukemia (CLL) Treated With Idelalisib and Rituximab in the Clinical Practice: a GIMEMA-ERIC Study', 'organization': {'class': 'OTHER', 'fullName': "Gruppo Italiano Malattie EMatologiche dell'Adulto"}, 'officialTitle': 'Efficacy and Safety in Patients With Chronic Lymphocytic Leukemia (CLL) Treated With Idelalisib and Rituximab in the Clinical Practice: a GIMEMA-ERIC Study', 'orgStudyIdInfo': {'id': 'LLC1718'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'All patients being observed during the study duration.', 'interventionNames': ['Drug: idelalisib and rituximab']}], 'interventions': [{'name': 'idelalisib and rituximab', 'type': 'DRUG', 'description': 'patients with treatment-naïve chronic lymphocytic leukemia (CLL) with TP53 disruption (i.e. 17p- or TP53 mutations) or relapsed/refractory CLL who were treated with idelalisib and rituximab', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cona', 'state': 'Ferrara', 'country': 'Italy', 'facility': 'AOU Arcispedale S.Anna - UOC Ematologia e fisiopatologia della coagulazione', 'geoPoint': {'lat': 44.80583, 'lon': 11.7069}}, {'city': 'Alessandria', 'country': 'Italy', 'facility': 'Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}, {'city': 'Ancona', 'country': 'Italy', 'facility': 'Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona- Sod Clinica Ematologica', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'city': 'Ascoli Piceno', 'country': 'Italy', 'facility': 'Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia', 'geoPoint': {'lat': 42.85351, 'lon': 13.57395}}, {'city': 'Asti', 'country': 'Italy', 'facility': 'Asl Di Asti, Ospedali Riuniti - Presidio Ospedaliero Cardinal G. Massaia - Sc Oncologia', 'geoPoint': {'lat': 44.90162, 'lon': 8.20751}}, {'city': 'Brescia', 'country': 'Italy', 'facility': 'Asst Degli Spedali Civili Di Brescia - Uo Ematologia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Cagliari', 'country': 'Italy', 'facility': 'AO Brotzu, PO A.Businco - SC Ematologia e CTMO', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'city': 'Catania', 'country': 'Italy', 'facility': 'Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Catanzaro', 'country': 'Italy', 'facility': 'Ao Di Catanzaro "Pugliese-Ciaccio", Presidio Ospedaliero "Ciaccio - de Lellis" - Ematologia', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'city': 'Florence', 'country': 'Italy', 'facility': 'Aou Careggi - Firenze - Sod Ematologia', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Meldola', 'country': 'Italy', 'facility': 'I.R.S.T. Srl Irccs - Meldola - Sc Oncologia Medica', 'geoPoint': {'lat': 44.12775, 'lon': 12.0626}}, {'city': 'Messina', 'country': 'Italy', 'facility': 'Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'country': 'Italy', 'facility': "Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora", 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Irccs Ospedale S. 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