Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-02-25 @ 5:34 PM
Study NCT ID:
NCT02244658
Status:
UNKNOWN
Last Update Posted:
2016-04-20
First Post:
2014-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recombinant Human Thrombopoietin (rhTPO) in Management of Chemotherapy-induced Thrombocytopenia in Acute Myelocytic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-18', 'studyFirstSubmitDate': '2014-09-13', 'studyFirstSubmitQcDate': '2014-09-18', 'lastUpdatePostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of platelet response', 'timeFrame': '21 days since the first administration', 'description': 'days that PLT count rebound to 30×10\\^9/L, 50×10\\^9/L and 100×10\\^9/L, respectively, from the minimal level after the very cycle of chemotherapy.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chemotherapy-induced thrombocytopenia', 'recombinant human thrombopoietin', 'acute myelocytic leukemia'], 'conditions': ['Antineoplastic Adverse Reaction', 'Thrombocytopenia', 'Acute Myelocytic Leukemia']}, 'descriptionModule': {'briefSummary': 'Chemotherapy-related myelosuppression usually occurs in AML patients, which induces severe thrombocytopenia and haemorrhage, a leading cause of death. This clinical trial aims at evaluating efficacy and safety of rhTPO in management of chemotherapy-induced thrombocytopenia in acute myelocytic leukemia.', 'detailedDescription': 'The investigators are undertaking a parallel group, multicentre, randomized controlled trial of 80 adults with chemotherapy-induced thrombocytopenia from 8 medical centers in China. AML patients with PLT count \\<30×10\\^9/L during the previous cycle of chemotherapy are randomized into two groups that one receives rhTPO at 1.0μg/kg·d subcutaneously for 7\\~14 consecutive days and the other receives no rhTPO or other thrombopoietic factor. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AML patients with PLT count \\<30×10\\^9/L during the previous cycle of chemotherapy to minimize the risk of clinically significant bleeding.\n\nExclusion Criteria:\n\n* allergic history to biological agents; history of thrombotic or hemorrhagic diseases; M3 or M7 subtype; pregnancy; hypertension; cardiovascular disease; diabetes; liver and kidney function impairment;'}, 'identificationModule': {'nctId': 'NCT02244658', 'briefTitle': 'Recombinant Human Thrombopoietin (rhTPO) in Management of Chemotherapy-induced Thrombocytopenia in Acute Myelocytic Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'Recombinant Human Thrombopoietin (rhTPO) in Management of Chemotherapy-induced Thrombocytopenia in Acute Myelocytic Leukemia: a Multicenter Clinical Trial', 'orgStudyIdInfo': {'id': 'RhTPO-AML thrombocytopenia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rhTPO', 'description': 'rhTPO 1.0 μg/kg·d subcutaneously for 7\\~14 consecutive days', 'interventionNames': ['Drug: rhTPO']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'no thrombopoietic agents'}], 'interventions': [{'name': 'rhTPO', 'type': 'DRUG', 'otherNames': ['TPIAO', 'S20050048/49 (SFDA, China)'], 'description': 'rhTPO 1.0 μg/kg·d subcutaneously for 7\\~14 consecutive days', 'armGroupLabels': ['rhTPO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ming Hou', 'role': 'CONTACT', 'email': 'houming@medmail.com.cn'}, {'name': 'Ming Hou', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Qilu hospital, Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Ming Hou', 'role': 'CONTACT', 'email': 'houming@medmail.com.cn'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Director', 'investigatorFullName': 'Ming Hou', 'investigatorAffiliation': 'Shandong University'}}}}