Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-20 @ 9:24 AM
Study NCT ID:
NCT01949818
Status:
UNKNOWN
Last Update Posted:
2015-12-30
First Post:
2013-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Diffuse Large B Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C036337', 'term': 'VAP-cyclo protocol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-28', 'studyFirstSubmitDate': '2013-09-20', 'studyFirstSubmitQcDate': '2013-09-24', 'lastUpdatePostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'up to end of follow-up-phase (approximately 24 months)'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': 'up to the date of death (approximately 5 years)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diffuse Large B Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of Yangzhengxiaoji Capsule Combination Chemotherapy for III/IV Diffuse Large B Cell Lymphoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time \\> 3 months Histological confirmed Diffuse large B cell lymphoma(III/IV) None of chemotherapy or radiotherapy has been previously used None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤ 1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L At least one measurable lesion None of other serious diseases, cardiopulmonary function is normal Pregnancy test of women at reproductive age must be negative Patients could be followed up None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments.\n\nExclusion Criteria:\n\n* Disagreement on blood sample collection Patients allergic of any of drug in this regimen or with metabolic disorder Pregnant or lactating women Serious medical illness likely to interfere with participation Serious infection Primitive or secondary tumors of central nervous system Chemotherapy or radiotherapy contraindication The evidence of CNS metastasis History of peripheral nervous disorder or dysphrenia patients participating in other clinical trials patients taking other antitumor drugs patients estimated to be unsuitable by investigation'}, 'identificationModule': {'nctId': 'NCT01949818', 'briefTitle': 'Treatment of Diffuse Large B Cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Zhengzhou University'}, 'officialTitle': 'A Randomized, Controlled Mutiple-center Clinical Research on the Treatment With Yangzhengxiaoji Capsule Combination Chemotherapy for III/IV Diffuse Large B Cell Lymphoma', 'orgStudyIdInfo': {'id': 'hnslblzlzx2011-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Yangzhengxiaoji Capsule combined with CHOP regimen', 'description': 'Yangzhengxiaoji Capsule combined with CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen', 'interventionNames': ['Drug: Yangzhengxiaoji capsule combined with CHOP regimen']}, {'type': 'EXPERIMENTAL', 'label': 'CHOP regimen', 'description': 'CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen', 'interventionNames': ['Drug: CHOP regimen']}], 'interventions': [{'name': 'Yangzhengxiaoji capsule combined with CHOP regimen', 'type': 'DRUG', 'description': 'Yangzhengxiaoji capsule combined with CHOP regimen(Yangzhengxiaoji capsule,Cyclophosphamide,Vincristine,Doxorubicin,Prednisone)Yangzhengxiaoji capsule ,1.56g,Tid,p.o,d7-21, Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5.', 'armGroupLabels': ['Yangzhengxiaoji Capsule combined with CHOP regimen']}, {'name': 'CHOP regimen', 'type': 'DRUG', 'description': 'CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5', 'armGroupLabels': ['CHOP regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450052', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mingzhi Zhanf, Dr', 'role': 'CONTACT', 'email': 'mingzhi_zhang@126.com', 'phone': '13838565629'}, {'name': 'Mingzhi Zhang, Dr', 'role': 'CONTACT', 'email': 'mingzhi_zhang@126.com', 'phone': '13838565629'}], 'facility': 'Oncology Department of The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Mingzhi Zhang, Dr', 'role': 'CONTACT', 'email': 'Mingzhi_zhang@126.com', 'phone': '13838565629'}], 'overallOfficials': [{'name': 'Mingzhi Zhang, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Zhengzhou University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mingzhi Zhang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'The director of oncology department of the first affiliated hospital', 'investigatorFullName': 'Mingzhi Zhang', 'investigatorAffiliation': 'Zhengzhou University'}}}}