Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2026-01-01 @ 2:10 AM
Study NCT ID:
NCT04025593
Status:
UNKNOWN
Last Update Posted:
2020-11-19
First Post:
2019-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarker Guided Treatment in DLBCL
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': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'C551803', 'term': 'ibrutinib'}, {'id': 'D000077269', 'term': 'Lenalidomide'}, {'id': 'C547816', 'term': 'N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide'}, {'id': 'D000077209', 'term': 'Decitabine'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-17', 'studyFirstSubmitDate': '2019-07-17', 'studyFirstSubmitQcDate': '2019-07-17', 'lastUpdatePostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete response rate', 'timeFrame': '21 days after 6 cycles of treatment (each cycle is 21 days)'}], 'secondaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': '2 year'}, {'measure': 'overall survival', 'timeFrame': '2 year'}, {'measure': 'overall response rate', 'timeFrame': '21 days after 6 cycles of treatment (each cycle is 21 days)'}, {'measure': 'Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0', 'timeFrame': 'Up to 30 days after completion of study treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diffuse Large B Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'This study is to investigate the strategy of biomarker guided treatment in diffuse large B cell lymphoma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed diffuse large B-cell lymphoma, CD20 positive\n* ECOG 0,1,2\n* Life expectancy\\>6 months\n* Informed consented\n* IPI\\>1\n\nExclusion Criteria:\n\n* Chemotherapy before\n* Stem cell transplantation before\n* History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix\n* Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease\n* Primary CNS lymphoma\n* LVEF≤50%\n* Lab at enrollment (Unless caused by lymphoma) Neutrophile\\<1.5\\*10\\^9/L Platelet\\<75\\*10\\^9/L ALT or AST \\>2\\*ULN,AKP or bilirubin \\>1.5\\*ULN Creatinine\\>1.5\\*ULN Other uncontrollable medical condition that may that may interfere the participation of the study Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation HIV infection If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.'}, 'identificationModule': {'nctId': 'NCT04025593', 'briefTitle': 'Biomarker Guided Treatment in DLBCL', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'A Randomized, Phase 2 Study of Biomarker Guided Treatment in DLBCL', 'orgStudyIdInfo': {'id': 'Guidance-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RCHOP', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Rituximab', 'Drug: Doxorubicin', 'Drug: Vincristine', 'Drug: Prednisone']}, {'type': 'EXPERIMENTAL', 'label': 'RCHOPX', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Rituximab', 'Drug: Doxorubicin', 'Drug: Vincristine', 'Drug: Prednisone', 'Drug: Ibrutinib', 'Drug: Lenalidomide', 'Drug: chidamide', 'Drug: decitabine']}], 'interventions': [{'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': '750mg/m2 day 1', 'armGroupLabels': ['RCHOP', 'RCHOPX']}, {'name': 'Rituximab', 'type': 'DRUG', 'description': '375mg/m2 day 0', 'armGroupLabels': ['RCHOP', 'RCHOPX']}, {'name': 'Doxorubicin', 'type': 'DRUG', 'description': '50mg/m2 day 1', 'armGroupLabels': ['RCHOP', 'RCHOPX']}, {'name': 'Vincristine', 'type': 'DRUG', 'description': '1.4mg/m2, max 2mg day 1', 'armGroupLabels': ['RCHOP', 'RCHOPX']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': '60mg/m2, max 100mg day 1-5', 'armGroupLabels': ['RCHOP', 'RCHOPX']}, {'name': 'Ibrutinib', 'type': 'DRUG', 'description': '420mg/day qd', 'armGroupLabels': ['RCHOPX']}, {'name': 'Lenalidomide', 'type': 'DRUG', 'description': '25mg day1-10', 'armGroupLabels': ['RCHOPX']}, {'name': 'chidamide', 'type': 'DRUG', 'description': '20mg day 1,4,8,11', 'armGroupLabels': ['RCHOPX']}, {'name': 'decitabine', 'type': 'DRUG', 'description': 'decitabine 10mg/m2 day-5 to day-1', 'armGroupLabels': ['RCHOPX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Pp X, MD, PhD', 'role': 'CONTACT', 'email': 'xpproc@msn.com', 'phone': '86-21-64370045', 'phoneExt': '610707'}, {'name': 'WL Z, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'PP X, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ruijin hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'WL Z, MD PhD', 'role': 'CONTACT', 'email': 'zhao.weili@yahoo.com', 'phone': '64370045', 'phoneExt': '610707'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy director of hematology department', 'investigatorFullName': 'Zhao Weili', 'investigatorAffiliation': 'Ruijin Hospital'}}}}