Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-29 @ 11:04 AM
Study NCT ID:
NCT00364468
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2006-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Finding Study of KRN125 (Pegfilgrastim) for Treatment of Neutropenic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009503', 'term': 'Neutropenia'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C455861', 'term': 'pegfilgrastim'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-28', 'studyFirstSubmitDate': '2006-08-14', 'studyFirstSubmitQcDate': '2006-08-14', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the duration of severe neutropenia'}]}, 'conditionsModule': {'keywords': ['pegfilgrastim', 'neutropenia', 'cancer patients', 'lymphoma'], 'conditions': ['Neutropenia']}, 'descriptionModule': {'briefSummary': 'To assess the duration of severe neutropenia in cycle 1 of chemotherapy after treatment with a single injection of KRN125 or multiple daily injections of filgrastim.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients diagnosed as malignant lymphoma\n* patients who were refractory to anthracycline or anthraquinone containing chemotherapy\n* patients who are going to receive ESHAP or CHASE treatment regimen\n* ECOG performance status =\\< 2\n* patients who have appropriate bone marrow, hepatic and renal functions\n* written informed consent\n\nExclusion Criteria:\n\n* double cancer\n* history of bone marrow transplantation or PBSCT\n* more than 2 prior chemotherapy regimens\n* primary hematologic disease such as myelodysplastic syndrome\n* previous radiotherapy within 4 weeks of enrollment\n* woman of childbearing potential who were either pregnant, breast feeding\n* patients who participated in other clinical trials within the last 4 weeks of enrollment'}, 'identificationModule': {'nctId': 'NCT00364468', 'briefTitle': 'Dose Finding Study of KRN125 (Pegfilgrastim) for Treatment of Neutropenic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'A Randomized Dose Finding Study of KRN125 (Pegfilgrastim) for the Treatment of Chemotherapy - Induced Neutropenia in Malignant Lymphoma', 'orgStudyIdInfo': {'id': 'KRN125/05-A04'}}, 'armsInterventionsModule': {'interventions': [{'name': 'pegfilgrastim', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aichi', 'country': 'Japan', 'facility': 'Tokai region', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Fukuoka, Nagasaki', 'country': 'Japan', 'facility': 'Kyusyu region'}, {'city': 'Gunma, Saitama, Tokyo, Kanagawa', 'country': 'Japan', 'facility': 'Kanto region'}, {'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Hokkaido region'}, {'city': 'Kyoto, Mie, Shiga', 'country': 'Japan', 'facility': 'Kinki region'}, {'city': 'Miyagi', 'country': 'Japan', 'facility': 'Tohoku region', 'geoPoint': {'lat': 26.62566, 'lon': 128.18236}}], 'overallOfficials': [{'name': 'Tomomitsu Hotta, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Nagoya Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}