Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT01901458
Status:
COMPLETED
Last Update Posted:
2015-03-19
First Post:
2013-07-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Two Different Collection Sets for Peripheral Blood Progenitor Cell Apheresis With Spectra Optia®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-18', 'studyFirstSubmitDate': '2013-07-10', 'studyFirstSubmitQcDate': '2013-07-15', 'lastUpdatePostDateStruct': {'date': '2015-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'levels of electrolytes before and after apheresis', 'timeFrame': 'day 1, day 30', 'description': 'sodium, potassium and calcium are measured before and after apherese and 30 days after collection'}, {'measure': 'kinetics of peripheral blood cell count', 'timeFrame': 'day 1, day30', 'description': 'measurement of the peripheral blood cell count before and after apheresis and 30 days after collection'}, {'measure': 'Peripheral blood CD62P before and after apheresis', 'timeFrame': 'day 1', 'description': 'Percentage of CD62P positive platelets as a measure of platelet activation during apheresis'}], 'primaryOutcomes': [{'measure': 'Throughput (TP)', 'timeFrame': 'Day 1', 'description': 'Efficiency of peripheral blood progenitor cell collection measured as throughput (collection rate (CR) per minute)'}], 'secondaryOutcomes': [{'measure': 'CR per total blood volume (TBV)', 'timeFrame': 'Day 1', 'description': 'Efficiency of peripheral blood progenitor cell collection measured as CR per TBV'}, {'measure': 'Collection efficiency (CE) 1', 'timeFrame': 'Day 1', 'description': 'Percentage of harvested cells per processed cells (calculated by use of the peripheral blood progenitor cell counts pre and post apheresis)'}, {'measure': 'CE2', 'timeFrame': 'Day 1', 'description': 'Percentage of harvested cells per processed cells (calculated by use of the peripheral blood progenitor cell count pre apheresis)'}, {'measure': 'Product T cells', 'timeFrame': 'Day 1', 'description': '% T cells as a definition of the cellular composition of the product'}, {'measure': 'Product NK cells', 'timeFrame': 'Day 1', 'description': '% NK cells as a definition of the cellular composition of the product'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['apheresis', 'peripheral blood progenitor cells', 'peripheral blood stem cells'], 'conditions': ['Healthy Allogeneic Donors', 'Granulocyte Colony-stimulating Factor (G-CSF) Mobilized']}, 'descriptionModule': {'briefSummary': 'The study will determine the advantage of the Spectra Optia® IDL set compared to the standard collection set for collection of peripheral blood progenitor cells using the Spectra Optia® apheresis system. The study will assess the reduction of apheresis time to obtain the required amount of hematopoietic progenitor cells.', 'detailedDescription': 'Peripheral blood progenitor cells (PBPC) collected by apheresis are the most common stem cell source for allogeneic hematopoietic stem cell transplantation.\n\nRecently, Terumo BCT introduced a novel automated apheresis system for PBPC collection. The Spectra Optia® apheresis system uses the Spectra Optia® Collection set and the MNC software for PBPC collection. This system combines continuous centrifugation (high g) and subsequent cellular collection into an elutriation chamber, where the platelets are elutriated from mononuclear cells. An optical sensor detects when red blood cells begin to be elutriated and subsequently triggers the collection of the buffy coat into the product bag by flushing the chamber with donor plasma. Thus PBPCs are harvested intermittently. In contrast, the same apheresis systems in combination with the Spectra Optia® IDL set and the WBC-D software, which has been designed to perform leukodepletion procedures, permits continuous PBPC centrifugation (low g) and harvesting.\n\nThe investigators hypothesis is that the use of the IDL set with manual adaption of the WBC-D-software allows a more efficient PBPC collection compared to the collection set which is recommended for PBPC collection. The apheresis time to collect the same amount of target cells dependent on the donors peripheral blood count will be shortened. In addition, the investigators want to compare both systems with respect to the cellular composition of the apheresis product and the donors platelet loss and coagulation parameters during apheresis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ability to give informed consent to participate in the study\n* meets german eligibility criteria (ZKRD-Standards, hemotherapy guidelines) for peripheral blood stem cell donation\n* has been treated with G-CSF 10 µg per kg per day for 5 days\n\nExclusion Criteria:\n\n* demand of concurrent plasma'}, 'identificationModule': {'nctId': 'NCT01901458', 'acronym': 'optiMaL', 'briefTitle': 'Two Different Collection Sets for Peripheral Blood Progenitor Cell Apheresis With Spectra Optia®', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'Prospective Randomized Trial Comparing Efficiency of Peripheral Blood Progenitor Cell Collection in Allogeneic Donors Using the Spectra Optia® IDL Set in Comparison With the Spectra Optia® MNC Collection Set', 'orgStudyIdInfo': {'id': 'ITZ-003'}, 'secondaryIdInfos': [{'id': 'CIV-13-10-011663', 'type': 'OTHER', 'domain': 'EUDAMED'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IDL-Set', 'description': 'Peripheral blood progenitor cell apheresis in G-CSF mobilized allogeneic donors using the Spectra Optia® IDL-Set in combination with the Spectra Optia® cell separator and the WBC-D program', 'interventionNames': ['Device: Spectra Optia® IDL-Set']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MNC-Set', 'description': 'Peripheral blood progenitor cell apheresis in G-CSF mobilized allogeneic donors using the Spectra Optia® Collection Set in combination with the Spectra Optia® cell separator and the MNC program', 'interventionNames': ['Device: Spectra Optia® Collection Set']}], 'interventions': [{'name': 'Spectra Optia® IDL-Set', 'type': 'DEVICE', 'description': 'Peripheral blood progenitor cell apheresis in G-CSF mobilized allogeneic donors using the Spectra Optia® cell separator', 'armGroupLabels': ['IDL-Set']}, {'name': 'Spectra Optia® Collection Set', 'type': 'DEVICE', 'description': 'Peripheral blood progenitor cell apheresis in G-CSF mobilized allogeneic donors using the Spectra Optia® cell separator', 'armGroupLabels': ['MNC-Set']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50670', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Cellex GmbH / Zentrum für Zellgewinnung (Standort Köln)', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Institut für Transplantantionsdiagnostik und Zelltherapeutika', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Johannes C Fischer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heinrich Heine University Hospital Duesseldorf'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, 'collaborators': [{'name': 'Terumo BCT', 'class': 'INDUSTRY'}, {'name': 'Chugai Pharma USA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}