Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-02-06 @ 4:13 AM
Study NCT ID:
NCT02287012
Status:
COMPLETED
Last Update Posted:
2016-10-07
First Post:
2014-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantification of the Time and Effort Required for Peripheral Blood Stem Cell Collection -The European Perspective
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 248}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-06', 'studyFirstSubmitDate': '2014-11-03', 'studyFirstSubmitQcDate': '2014-11-06', 'lastUpdatePostDateStruct': {'date': '2016-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Type, duration and length of administration of mobilizing agents', 'timeFrame': 'one week', 'description': 'Number of visits for administration of mobilizing agents Duration (days) of administration of mobilizing agents Type of agents used as mobilizing agents'}, {'measure': 'Number and length of apheresis sessions and number of collected stem cells', 'timeFrame': 'one week', 'description': 'Number of apheresis sessions Number of hours of apheresis sessions Attainment of CD34+ cells target (yes, no) Number of days until CD34+ target level is met'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': 'This study aims to observe the effects of the availability of plerixafor on the time and effort associated with autologous peripheral blood stem cell collection.', 'detailedDescription': 'This non interventional study will consist of two parts:\n\nI. Retrospective study:\n\nA medical record review will be conducted covering 200 patients file undergoing peripheral blood stem cell mobilization in some European centers.\n\nII. Prospective study :Time/Motion evaluation of actual apheresis - 20 events each center The actual apheresis events will be measured in consecutive patients scheduled to be candidates for peripheral blood stem mobilization in the apheresis area of the hospital. Each apheresis will be considered as one event . Should the patient receive more than 1 apheresis, each apheresis will be considered as one different event.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will consist of two parts:\n\nI. Retrospective study:\n\nA medical record review will be conducted covering 200 patients file undergoing peripheral blood stem cell mobilization in different European centers. Patients will be selected from each of centers, evenly divided between two eras: 1) prior to approval of plerixafor= Pre-P era (July 2009); and 2) after approval of plerixafor= P era .\n\nII. Prospective study :Time/Motion evaluation of actual apheresis - 20 events each center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients must satisfy the following for the part 1\n\n* Oncology patients diagnosed with Non-Hodgkin lymphoma who are candidates for autologous hematopoietic stem cell transplantation (HSCT)\n* A patient that fails to achieve a target CD34+\\>20 cells/µl, before or on the first day of apheresis\n* Age \\> 18 years\n\nExclusion Criteria for the part 1\n\nPatients with:\n\n* Age \\< 18 years;\n* Primary diagnosis other than Non-Hodgkin lymphoma\n* Undergone prior autologous hematopoietic stem cell transplantation (HSCT)'}, 'identificationModule': {'nctId': 'NCT02287012', 'briefTitle': 'Quantification of the Time and Effort Required for Peripheral Blood Stem Cell Collection -The European Perspective', 'organization': {'class': 'OTHER', 'fullName': 'Association for Training, Education, and Research in Hematology, Immunology, and Transplantation'}, 'officialTitle': 'Quantification of the Time and Effort Required for Peripheral Blood Stem Cell Collection - The European Perspective', 'orgStudyIdInfo': {'id': 'Mozo Time and Motion'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pre-Plerixafor era', 'description': 'The first era (Pre-Plerixafor era) will be defined as a two year period immediately preceding commercialization of plerixafor in Europe, (e.g., June 1, 2007 through June 1, 2009).'}, {'label': 'Plerixafor era', 'description': 'The second era (Plerixafor era) will be defined as July 1, 2010 through July 1, 2012).', 'interventionNames': ['Other: Time/Motion evaluation of actual apheresis']}], 'interventions': [{'name': 'Time/Motion evaluation of actual apheresis', 'type': 'OTHER', 'description': 'The actual apheresis events will be measured in consecutive patients scheduled to be candidates for peripheral blood stem mobilization in the apheresis area of the hospital. Each apheresis will be considered as one event . Should the patient receive more than 1 apheresis, each apheresis will be considered as one different event.', 'armGroupLabels': ['Plerixafor era']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mohamad Mohty, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Saint-Antoine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pr Mohamad MOHTY', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pr Mohamad MOHTY', 'investigatorAffiliation': 'Association for Training, Education, and Research in Hematology, Immunology, and Transplantation'}}}}