Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-03-06 @ 6:06 PM
Study NCT ID:
NCT03014102
Status:
UNKNOWN
Last Update Posted:
2019-12-06
First Post:
2017-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recombinant Human Thrombopoietin for Mobilization of Peripheral Blood Progenitor Cells for Autologous Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013926', 'term': 'Thrombopoietin'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-05', 'studyFirstSubmitDate': '2017-01-05', 'studyFirstSubmitQcDate': '2017-01-06', 'lastUpdatePostDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the average number of cluster of differentiation 34 positive cells/kg', 'timeFrame': 'up to 24 months', 'description': 'To evaluate the effect of combining various treatment schedules of recombinant human thrombopoietin with granulocyte colony stimulating factor on the mobilization of peripheral blood progenitor cells.'}]}, 'conditionsModule': {'conditions': ['Thrombocytopoietin', 'Hematopoietic Stem Cell Mobilization', 'Hematopoietic Stem Cell Transplantation']}, 'referencesModule': {'references': [{'pmid': '34505019', 'type': 'DERIVED', 'citation': 'Mo H, Liu P, Qin Y, He X, Han X, Yao J, Su W, Zhang S, Tang L, Zhao F, Gui L, Yang S, Yang J, Zhou S, Zhang Z, Shi Y. Recombinant human thrombopoietin prior to mobilization chemotherapy facilitates platelet recovery in autologous transplantation in patients with lymphoma: Results of a prospective randomized study. Chronic Dis Transl Med. 2021 Jun 24;7(3):190-198. doi: 10.1016/j.cdtm.2021.05.003. eCollection 2021 Sep.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether recombinant human thrombopoietin are effective in peripheral blood progenitor cells mobilization for autologous transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* a histologically confirmed diagnosis of Hodgkin's disease, non-Hodgkin's lymphoma, or selected high-risk solid tumors that are planned to receive autologous peripheral blood progenitor cell transplantation\n* Eastern Cooperative Oncology Group performance status of 0 - 2.\n\nExclusion Criteria:\n\n* abnormal liver function (aminotransferase or bilirubin levels 2 times upper limit of normal), leukopenia (white blood cell count 3000/L), or a history of platelet or other disorders associated with a bleeding diathesis\n* a history of thromboembolic disease, coronary heart disease,stroke, arrhythmias, central nervous system metastases,or other organ system diseases or abnormalities that might predispose individuals to treatment-related complications"}, 'identificationModule': {'nctId': 'NCT03014102', 'briefTitle': 'Recombinant Human Thrombopoietin for Mobilization of Peripheral Blood Progenitor Cells for Autologous Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'orgStudyIdInfo': {'id': 'LC2016B03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TPOqd', 'description': 'Recombinant Human Thrombopoietin 300U/kg/d ih quaque die, day-3/-2/-1 before mobilization', 'interventionNames': ['Drug: Recombinant Human Thrombopoietin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TPOqod', 'description': 'Recombinant Human Thrombopoietin 300U/kg/d ih qua altera die, day-3/-1/+2 before mobilization', 'interventionNames': ['Drug: Recombinant Human Thrombopoietin']}], 'interventions': [{'name': 'Recombinant Human Thrombopoietin', 'type': 'DRUG', 'description': 'Recombinant human Thrombopoietin is a full length glycosylated molecule identical to endogenous Thrombopoietin.', 'armGroupLabels': ['TPOqd', 'TPOqod']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongnan Mo, MD', 'role': 'CONTACT', 'email': 'mhnzlyynk@outlook.com', 'phone': '8610-87788103'}], 'facility': 'Cancer Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Hongnan Mo, MD', 'role': 'CONTACT', 'email': 'mhnzlyynk@outlook.com', 'phone': '8610-87787451'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hongnan Mo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Attending Physician', 'investigatorFullName': 'Hongnan Mo', 'investigatorAffiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}}}}