Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2026-02-28 @ 8:19 AM
Study NCT ID:
NCT01689350
Status:
COMPLETED
Last Update Posted:
2014-09-08
First Post:
2012-09-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Prospective Study of Cyclophosphamide in Systemic Lupus Erythematosus Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chlingy@mail2.sysu.edu.cn', 'phone': '+8615018706960', 'title': 'Lingyan CHEN, Master candidate', 'organization': 'School of Pharmaceutical Sciences, Sun Yat-sen University'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The sample size is too small to evaluate the significance of the cyclophosphamide (CPA) medication based on genotypes. We need to enroll more SLE patients in the following study.'}}, 'adverseEventsModule': {'timeFrame': 'One month for all the adverse events reporting.', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental Group', 'description': 'Cyclophosphamide (CPA) medication was according to the genotypes of SLE patients.', 'otherNumAtRisk': 47, 'otherNumAffected': 8, 'seriousNumAtRisk': 47, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Cyclophosphamide (CPA) medication was according to the traditional experiences.', 'otherNumAtRisk': 45, 'otherNumAffected': 16, 'seriousNumAtRisk': 45, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Leucopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adverse Reaction (Leucopenia)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': 'CPA medication was according to the genotypes of SLE patients.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'CPA medication was according to the traditional experiences.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '1.76', 'upperLimit': '14.14'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '1.76', 'upperLimit': '14.14'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.99', 'ciLowerLimit': '1.76', 'ciUpperLimit': '14.14', 'groupDescription': 'Null hypothesis: there is no difference between the control group and experimental group in terms of frequency of leucopenia.(α=0.05） Chi-square test was applied to test the difference. The Chi-square value was 10.08 and the P-value was 0.0015, which indicated that the null hypothesis could be rejected.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'one month', 'description': 'The count of white cells \\< 4.0 × 10ˆ9/L in SLE patient who received CPA medication was considered as CPA-induced leucopenia.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Reaction ( Infection )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': 'CPA medication was according to the genotypes of SLE patients.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'CPA medication was according to the traditional experiences.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.69', 'ciLowerLimit': '1.01', 'ciUpperLimit': '7.13', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'one month', 'description': 'Flu-like symptoms, Upper respiratory tract infection，and the etc.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental Group', 'description': 'Cyclophosphamide (CPA) medication was according to the genotypes of SLE patients.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Cyclophosphamide (CPA) medication was according to the traditional experiences.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group', 'description': '45 cases in control group received traditional therapy that the initial dose of cyclophosphamide (CPA) was 0.2-0.6g/week injection according to clinical experience.'}, {'id': 'BG001', 'title': 'Experimental Group', 'description': '47 cases in experimental group were genotyped as extensive metaboliser (EM), intermediate metaboliser (IM) and poor metaboliser (PM）with initial dose of CPA as 0.2g, 0.4g and 0.6g per week by injection, respectively.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.40', 'spread': '13.28', 'groupId': 'BG000'}, {'value': '31.15', 'spread': '13.21', 'groupId': 'BG001'}, {'value': '30.78', 'spread': '13.17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Chinese Han', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'SLE patients', 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'SLE patients who met the ACR criteria and applied CPA medication were included.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-27', 'studyFirstSubmitDate': '2012-09-17', 'resultsFirstSubmitDate': '2014-06-10', 'studyFirstSubmitQcDate': '2012-09-20', 'lastUpdatePostDateStruct': {'date': '2014-09-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-08-27', 'studyFirstPostDateStruct': {'date': '2012-09-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Reaction (Leucopenia)', 'timeFrame': 'one month', 'description': 'The count of white cells \\< 4.0 × 10ˆ9/L in SLE patient who received CPA medication was considered as CPA-induced leucopenia.'}], 'secondaryOutcomes': [{'measure': 'Adverse Reaction ( Infection )', 'timeFrame': 'one month', 'description': 'Flu-like symptoms, Upper respiratory tract infection，and the etc.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cyclophosphamide', 'genotype-based therapy', 'prospective study'], 'conditions': ['Systemic Lupus Erythematosus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the genotype-based personal prescription of cyclophosphamide with the traditional prescription.', 'detailedDescription': 'Cyclophosphamide (CPA) has been one of the most successful therapies for severe Systemic lupus erythematosus (SLE). However, cyclophosphamide can cause severe side effects, including bone marrow suppression, infection, gastrointestinal reaction, hemorrhagic cystitis, and the etc. Significant variation in efficacy and toxicity of CPA has been observed. Since the development of applicable therapeutic drug monitoring (TDM) of cyclophosphamide has been reported, it will help to improve the efficacy and reduce toxicities in SLE treatment. However, the TDM is a passive strategy which usually lags behind the appearance of toxicities. Therefore，it is especially crucial to give individuals genotype-based personal prescription of cyclophosphamide in order to gain the most effective therapies. Thus, the purpose of this study is to compare the genotype-based personal prescription of cyclophosphamide with the traditional prescription, in order to verify the efficacy of the genotype-based personal prescription.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The American College of Rheumatology established eleven criteria in 1982,which were revised in 1997 as a classificatory instrument to operationalise the definition of SLE in clinical trials.\n\n 1. Malar rash (rash on cheeks).\n 2. Discoid rash (red, scaly patches on skin that cause scarring).\n 3. Serositis: Pleurisy (inflammation of the membrane around the lungs) or pericarditis (inflammation of the membrane around the heart).\n 4. Oral ulcers (includes oral or nasopharyngeal ulcers).\n 5. Arthritis: nonerosive arthritis of two or more peripheral joints, with tenderness, swelling, or effusion.\n 6. Photosensitivity (exposure to ultraviolet light causes rash, or other symptoms of SLE flareups).\n 7. Blood-hematologic disorder-hemolytic anemia (low red blood cell count) or leukopenia (white blood cell count\\<4000/µl), lymphopenia (\\<1500/µl) or thrombocytopenia (\\<100000/µl) in the absence of offending drug. Hypocomplementemia is also seen, due to either consumption of C3 and C4 by immune complex-induced inflammation or to congenitally complement deficiency, which may predispose to SLE.\n 8. Renal disorder: More than 0.5 g per day protein in urine or cellular casts seen in urine under a microscope.\n 9. Antinuclear antibody test positive.\n 10. Immunologic disorder: Positive anti-Smith, anti-ds DNA, antiphospholipid antibody, and/or false positive serological test for syphilis. Presence of anti-ss DNA in 70% of cases (though also positive with rheumatic disease and healthy persons).\n 11. Neurologic disorder: Seizures or psychosis. For the purpose of identifying patients for clinical studies, a person has SLE if any 4 out of 11 symptoms are present simultaneously or serially on two separate occasions. In the meantime, the case has one of the following conditions or more;\n\n <!-- -->\n\n 1. HIV (-);\n 2. Signed the informed consent;\n 3. Taking contraceptive measures during treatment period.\n\nExclusion Criteria:\n\n* Poor compliance;\n* With lupus mental damage complication, occurrence of epilepsy or unable to express subjective symptoms during the observation period.\n* Taking drugs that affect cytochrome P450 2B6, cytochrome P450 3A4 and cytochrome P450 2C19, except corticosteroids.\n* Abnormal liver function.'}, 'identificationModule': {'nctId': 'NCT01689350', 'acronym': 'SLE', 'briefTitle': 'A Prospective Study of Cyclophosphamide in Systemic Lupus Erythematosus Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Prospective Study Based on Genetic Polymorphisms Related to Individual Variations of Side Effects of Cyclophosphamide in Systemic Lupus Erythematosus Treatment', 'orgStudyIdInfo': {'id': '2012ZX09506001-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'The cases in control group received traditional therapy that the initial dose of cyclophosphamide (CPA) was 0.2-0.6g/week injection according to clinical experience.'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Genetic: Genotype Detection To Genotype cases in the experimental group and divide them into three groups, including extensive metaboliser (EM), intermediate metaboliser (IM) and poor metaboliser (PM),with initial dose of CPA as 0.2g, 0.4g and 0.6g per week by injection, respectively.', 'interventionNames': ['Genetic: Genotype Detection']}], 'interventions': [{'name': 'Genotype Detection', 'type': 'GENETIC', 'description': 'To Genotype cases in the experimental group and divide them into three groups, including extensive metaboliser (EM), intermediate metaboliser (IM) and poor metaboliser (PM).', 'armGroupLabels': ['Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510006', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'School of Pharmaceutical Sciences Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Huang Min, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master Graduate Student', 'investigatorFullName': 'Lingyan Chen', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}