Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-03 @ 8:38 PM
Study NCT ID:
NCT02273856
Status:
TERMINATED
Last Update Posted:
2016-06-21
First Post:
2014-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicentre Registry of Treatments and Outcomes in Patients With Chronic Lymphocytic Leukaemia (CLL) Or Indolent Non Hodgkin's Lymphoma (iNHL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The study was terminated due to insufficient subject enrollment and very slow enrollment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-17', 'studyFirstSubmitDate': '2014-09-02', 'studyFirstSubmitQcDate': '2014-10-22', 'lastUpdatePostDateStruct': {'date': '2016-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Proportion of patients on different types of pharmacological regimen for treatment of Chronic Lymphocytic Leukaemia (CLL) or Indolent Non Hodgkin's Lymphoma (iNHL)", 'timeFrame': 'Baseline, 1 year and 2 years after baseline (up to 30 months)', 'description': 'Types of combination treatment (including but not limited to R-CHOP \\[rituximab, cyclophosphamide, vincristine, doxorubicin, prednisone\\] , FCR \\[fludarabine, cyclophosphamide, rituximab\\], COP \\[cyclophosphamide, doxorubicin, prednisone\\], BR \\[bendamustine, rituximab\\], etc.) will be collected in treatment-naïve and relapsed patients. Data to be described as percentage of patients on each regimen.'}], 'secondaryOutcomes': [{'measure': 'Duration of response', 'timeFrame': 'up to 30 months'}, {'measure': 'Overall survival', 'timeFrame': 'up to 30 months'}, {'measure': 'Progression free survival', 'timeFrame': 'up to 30 months'}, {'measure': 'Number of subjects in complete remission', 'timeFrame': 'up to 30 months'}, {'measure': 'Number of subjects in partial remission', 'timeFrame': 'up to 30 months'}, {'measure': 'Disease type and staging', 'timeFrame': 'up to 30 months'}, {'measure': 'Clinical responses', 'timeFrame': 'up to 30 months', 'description': 'Relapses, response or non-response to treatment'}, {'measure': 'Safety as assessed by adverse events', 'timeFrame': 'up to 30 months'}, {'measure': 'CLL specific variable: Histology', 'timeFrame': 'up to 30 months', 'description': "Proportion of different subtypes in CLL: (1) histologically indolent CLL (HIC), defined as morphologically typical CLL with no histologic features of progression or transformation such as increased large cells, large confluent proliferation centers, or high proliferation rate; (2) CLL with histological features of intermediate aggressiveness histologically aggressive CLL \\[HAC\\]) (3) Richter's syndrome. Data to be described as percentage."}, {'measure': 'iNHL specific variables: Histology', 'timeFrame': 'up to 30 months', 'description': 'Proportion of different subtypes in iNHL will be presented. Data to be described as percentage.'}, {'measure': 'Health-related quality of life variables', 'timeFrame': 'up to 30 months', 'description': 'Using EQ-5D questionnaire, including a visual analog scale (dimensions): mobility, self-care, usual activities, pain/discomfort, anxiety/depression'}, {'measure': 'CLL specific variable: Rai/Binet staging systems', 'timeFrame': 'up to 30 months', 'description': 'Percentage of patients in the different stages.'}, {'measure': 'CLL specific variable: Clinically relevant biomarker status', 'timeFrame': 'up to 30 months', 'description': 'Includes immunoglobulin heavy chain variable (IgHV) status, ZAP-70 (70-kDa zeta-associated protein), receptor status (including CD20), cytogenetics (6q, 11q, 13q, and 17p deletion or monosomy, trisomy 12 ). Percentages will be presented for the clinically relevant biomarker status.'}, {'measure': 'iNHL specific variables: Ann Arbor staging classification', 'timeFrame': 'up to 30 months', 'description': 'Percentage of patients in the different stages.'}, {'measure': 'iNHL specific variables: Clinically relevant biomarker status', 'timeFrame': 'up to 30 months', 'description': 'Includes receptor status (including CD20). Percentages will be presented for the clinically relevant biomarker status.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Lymphocytic Leukaemia (CLL)', "Indolent Non Hodgkin's Lymphoma (iNHL)"], 'conditions': ["Indolent Non Hodgkin's Lymphoma (iNHL)", 'Chronic Lymphocytic Leukaemia (CLL)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to document the pharmacological treatment strategies used in treatment naïve and previously treated relapsed/refractory iNHL/CLL patients in the Middle East and North African (MENA) region. This study will also record encountered tumor subtype and stage and the instituted pharmacological treatments, as well as assess the clinical outcomes of treatments.', 'detailedDescription': 'Patients will be followed up to 30 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients are from the MENA region, and will be selected from sites that are considered clinical centres of excellence in the region.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* CLL patients or\n* iNHL patients\n* Clinical decision made to initiate or adapt treatment of CLL/iNHL("Need to treat")\n\nExclusion Criteria:\n\n* Patient deemed unfit for enrollment by the documented opinion of the investigator\n* Watch and wait patients\n* Richter\'s transformation\n* Patients otherwise not eligible for (pharmacological) intervention\n* Moribund patients'}, 'identificationModule': {'nctId': 'NCT02273856', 'acronym': 'NADIR', 'briefTitle': "Multicentre Registry of Treatments and Outcomes in Patients With Chronic Lymphocytic Leukaemia (CLL) Or Indolent Non Hodgkin's Lymphoma (iNHL)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': "Prospective Multicentre Observational Registry Of Treatments And Outcomes In Patients With Chronic Lymphocytic Leukaemia Or Indolent Non Hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': 'ONC-MA-1002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment naïve patients with CLL'}, {'label': 'Treatment naïve patients with iNHL'}, {'label': 'Relapsed/refractory patients with CLL'}, {'label': 'Relapsed/refractory patients with iNHL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '22110', 'city': 'Irbid', 'state': 'Irbid Governorate', 'country': 'Jordan', 'facility': 'Site JO96201 King Abdullah University Hospital', 'geoPoint': {'lat': 32.55556, 'lon': 35.85}}, {'zip': '70653', 'city': 'Ash Shuwaykh', 'state': 'Shuwaikh', 'country': 'Kuwait', 'facility': 'Site KW96501 Kuwait Cancer Control Center', 'geoPoint': {'lat': 29.34361, 'lon': 47.94611}}, {'zip': '1600', 'city': 'Beirut', 'state': 'Beyrouth', 'country': 'Lebanon', 'facility': 'Site Hammoud Hospital University Medical Center', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'zip': '166830', 'city': 'Beirut', 'state': 'Beyrouth', 'country': 'Lebanon', 'facility': 'Site Hotel Dieu De France', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'zip': '123', 'city': 'Muscat', 'state': 'Muḩāfaz̧at Masqaţ', 'country': 'Oman', 'facility': 'Site OM96801 Sultan Qaboos University Hospital', 'geoPoint': {'lat': 23.58413, 'lon': 58.40778}}, {'zip': '3050', 'city': 'Doha', 'state': 'Baladīyat ad Dawḩah', 'country': 'Qatar', 'facility': 'Site Hamad Medical Coorporation, National Center for Cancer Care and Research, Al Amal Hospital', 'geoPoint': {'lat': 25.28545, 'lon': 51.53096}}, {'zip': '61421', 'city': 'Abhā', 'state': "'Asir Region", 'country': 'Saudi Arabia', 'facility': 'Site SA96601 Aseer Central Hospital', 'geoPoint': {'lat': 18.21639, 'lon': 42.50528}}, {'zip': '51900', 'city': 'Abu Dhabi', 'state': 'Abu Dhabi Emirate', 'country': 'United Arab Emirates', 'facility': 'Site AE97101 Sheikh Khalifa Medical City', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma International B.V.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma International B.V.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}