Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-03-03 @ 2:06 PM
Study NCT ID:
NCT03043105
Status:
UNKNOWN
Last Update Posted:
2020-04-16
First Post:
2017-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
TCP Regimen in Newly Diagnosed MCD:a Prospective, Single-center, Single-arm, Phase-II Pilot Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537372', 'term': "Multi-centric Castleman's Disease"}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013792', 'term': 'Thalidomide'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'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': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lijian@pumch.cn', 'phone': '86-010-69155027', 'title': 'Dr. Jian Li', 'organization': 'Peking Union Medical College Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Safety data were collected until 30 days after the last dose of study drugs, except for secondary primary malignancies (which were assessed throughout the duration of follow-up, up to 4 years). Secondary primary malignancies were assessed throughout the duration of follow-up, up to 3 years.', 'eventGroups': [{'id': 'EG000', 'title': 'TCP Treatment Group', 'description': 'The newly-diagnosed symptomatic MCD patients received thalidomide, cyclophosphamide and prednisone (TCP ) treatment. The accurate dose of TCP regimen is listed as follows.\n\n* Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year;\n* Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year;\n* Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 10, 'seriousNumAtRisk': 25, 'deathsNumAffected': 3, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pulmonary infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Durable Tumor and Symptomatic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TCP Treatment Group', 'description': 'The newly-diagnosed symptomatic MCD patients received thalidomide, cyclophosphamide and prednisone (TCP ) treatment. The accurate dose of TCP regimen is listed as follows.\n\n* Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year;\n* Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year;\n* Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to the time point when a patient achieves treatment response for 24 weeks.', 'description': "Durable tumor and symptomatic response is complete response (CR) + partial response (PR). CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to multicentric Castleman's disease, sustained for at least 18 weeks. PR: \\>=50 percent decrease in sum of the product of the diameters of indicator lesion(s), with at least stable disease in all other evaluable disease in the absence of treatment failure sustained for at least 6 months.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TCP Treatment Group', 'description': 'The newly-diagnosed symptomatic MCD patients received thalidomide, cyclophosphamide and prednisone (TCP ) treatment. The accurate dose of TCP regimen is listed as follows.\n\n* Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year;\n* Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year;\n* Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.32', 'groupId': 'OG000', 'lowerLimit': '17.22', 'upperLimit': '29.42'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months', 'description': 'Progression-free survival (PFS) is defined as the time to death or treatment failure. Treatment failure is defined as: sustained increase in grade ≥2 disease-related symptoms persisting ≥12 weeks; new disease-related grade ≥3 symptoms; sustained \\>1 point increase in ECOG-PS persisting for ≥12 weeks; radiological progression; or initiation of another treatment for MCD.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TCP Treatment Group', 'description': 'The newly-diagnosed symptomatic MCD patients received thalidomide, cyclophosphamide and prednisone (TCP ) treatment. The accurate dose of TCP regimen is listed as follows.\n\n* Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year;\n* Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year;\n* Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.16', 'groupId': 'OG000', 'lowerLimit': '28.08', 'upperLimit': '36.24'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From date of randomization until the date of death from any cause, assessed up to 36 months.', 'description': "Overall survival, defined as the time to patients' death, is measured.", 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in SF-36 Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TCP Treatment Group', 'description': 'The newly-diagnosed symptomatic MCD patients received thalidomide, cyclophosphamide and prednisone (TCP ) treatment. The accurate dose of TCP regimen is listed as follows.\n\n* Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year;\n* Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year;\n* Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year.'}], 'classes': [{'title': 'physical functioning', 'categories': [{'measurements': [{'value': '15.1', 'spread': '6.78', 'groupId': 'OG000'}]}]}, {'title': 'role physical', 'categories': [{'measurements': [{'value': '26.7', 'spread': '10.53', 'groupId': 'OG000'}]}]}, {'title': 'role emotional', 'categories': [{'measurements': [{'value': '19.6', 'spread': '10.18', 'groupId': 'OG000'}]}]}, {'title': 'vitality', 'categories': [{'measurements': [{'value': '11.1', 'spread': '5.75', 'groupId': 'OG000'}]}]}, {'title': 'mental health', 'categories': [{'measurements': [{'value': '8.5', 'spread': '5.50', 'groupId': 'OG000'}]}]}, {'title': 'social functioning', 'categories': [{'measurements': [{'value': '13.6', 'spread': '6.70', 'groupId': 'OG000'}]}]}, {'title': 'bodily pain', 'categories': [{'measurements': [{'value': '15.8', 'spread': '6.19', 'groupId': 'OG000'}]}]}, {'title': 'general health', 'categories': [{'measurements': [{'value': '9.1', 'spread': '4.78', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 24 weeks after treatment.', 'description': "SF-36 score is a self-administered scoring system which reflects a patient's general health status. SF-36 contains 8 dimensions, including physical functioning, role physical, role emotional, vitality, mental health, social functioning, bodily pain, and general health. Each dimension ranges from 0 to 100. Higher scores mean better outcome. SF-36 score at baseline was compared with SF-36 score at 24 weeks.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each patient is assessed by SF-36 scoring system, which contains 8 dimensions, including physical functioning, role physical, role emotional, vitality, mental health, social functioning, bodily pain, and general health.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 ( ≥1 Grade)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TCP Treatment Group', 'description': 'The newly-diagnosed symptomatic MCD patients received thalidomide, cyclophosphamide and prednisone (TCP ) treatment. The accurate dose of TCP regimen is listed as follows.\n\n* Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year;\n* Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year;\n* Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From initiation of TCP regimen to 3 months after the end of treatment or to time point of the initiation of second line therapy.', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (patients with grades ≥1 would be included)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-related Serious Adverse Events as Assessed by CTCAE v4.0 ( ≥3 Grade)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TCP Treatment Group', 'description': 'The newly-diagnosed symptomatic MCD patients received thalidomide, cyclophosphamide and prednisone (TCP ) treatment. The accurate dose of TCP regimen is listed as follows.\n\n* Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year;\n* Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year;\n* Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From initiation of TCP regimen to 3 months after the end of treatment or to time point of the initiation of second line therapy.', 'description': 'Number of participants with treatment-related serious adverse events as assessed by CTCAE v4.0 (patients with grades ≥3 would be included)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TCP Treatment Group', 'description': 'The newly-diagnosed symptomatic MCD patients received thalidomide, cyclophosphamide and prednisone (TCP ) treatment. The accurate dose of TCP regimen is listed as follows.\n\n* Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year;\n* Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year;\n* Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'TCP Treatment Group', 'description': 'The newly-diagnosed symptomatic MCD patients received thalidomide, cyclophosphamide and prednisone (TCP ) treatment. The accurate dose of TCP regimen is listed as follows.\n\n* Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year;\n* Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year;\n* Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '63'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'East Asian', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-01', 'size': 242423, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-06T07:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'open-labeled'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This will be a single center, single arm, phase-II pilot study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-05', 'studyFirstSubmitDate': '2017-01-31', 'resultsFirstSubmitDate': '2020-02-09', 'studyFirstSubmitQcDate': '2017-02-01', 'lastUpdatePostDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-05', 'studyFirstPostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Durable Tumor and Symptomatic Response', 'timeFrame': 'From baseline to the time point when a patient achieves treatment response for 24 weeks.', 'description': "Durable tumor and symptomatic response is complete response (CR) + partial response (PR). CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to multicentric Castleman's disease, sustained for at least 18 weeks. PR: \\>=50 percent decrease in sum of the product of the diameters of indicator lesion(s), with at least stable disease in all other evaluable disease in the absence of treatment failure sustained for at least 6 months."}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months', 'description': 'Progression-free survival (PFS) is defined as the time to death or treatment failure. Treatment failure is defined as: sustained increase in grade ≥2 disease-related symptoms persisting ≥12 weeks; new disease-related grade ≥3 symptoms; sustained \\>1 point increase in ECOG-PS persisting for ≥12 weeks; radiological progression; or initiation of another treatment for MCD.'}, {'measure': 'Overall Survival', 'timeFrame': 'From date of randomization until the date of death from any cause, assessed up to 36 months.', 'description': "Overall survival, defined as the time to patients' death, is measured."}, {'measure': 'Change in SF-36 Score', 'timeFrame': 'From baseline to 24 weeks after treatment.', 'description': "SF-36 score is a self-administered scoring system which reflects a patient's general health status. SF-36 contains 8 dimensions, including physical functioning, role physical, role emotional, vitality, mental health, social functioning, bodily pain, and general health. Each dimension ranges from 0 to 100. Higher scores mean better outcome. SF-36 score at baseline was compared with SF-36 score at 24 weeks."}, {'measure': 'Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 ( ≥1 Grade)', 'timeFrame': 'From initiation of TCP regimen to 3 months after the end of treatment or to time point of the initiation of second line therapy.', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (patients with grades ≥1 would be included)'}, {'measure': 'Number of Participants With Treatment-related Serious Adverse Events as Assessed by CTCAE v4.0 ( ≥3 Grade)', 'timeFrame': 'From initiation of TCP regimen to 3 months after the end of treatment or to time point of the initiation of second line therapy.', 'description': 'Number of participants with treatment-related serious adverse events as assessed by CTCAE v4.0 (patients with grades ≥3 would be included)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Multicentric Castleman's Disease", 'Thalidomide, cyclophosphamide and prednisone (TCP regimen)', 'Efficacy', 'Safety'], 'conditions': ['Multicentric Castleman Disease']}, 'referencesModule': {'references': [{'pmid': '30760451', 'type': 'DERIVED', 'citation': 'Zhang L, Zhao AL, Duan MH, Li ZY, Cao XX, Feng J, Zhou DB, Zhong DR, Fajgenbaum DC, Li J. Phase 2 study using oral thalidomide-cyclophosphamide-prednisone for idiopathic multicentric Castleman disease. Blood. 2019 Apr 18;133(16):1720-1728. doi: 10.1182/blood-2018-11-884577. Epub 2019 Feb 13.'}]}, 'descriptionModule': {'briefSummary': "To explore the effectiveness and safety of thalidomide, cyclophosphamide and prednisone (TCP regimen) in newly diagnosed Multicentric Castleman's disease (MCD) patients.", 'detailedDescription': "This is a single center, open-labeled , single arm, phase-II pilot study which aims to evaluate the efficacy and safety of thalidomide, cyclophosphamide and prednisone (TCP regimen) in newly diagnosed Multicentric Castleman's disease (MCD) patients.There would be two phases of the study. The treatment and the response evaluation phase will last from the time of enrollment up to 24 months (evaluation will be carried out every 3 months). The follow-up phase to assess for progression of disease will last from 24 months (2 years) to 4 years after enrollment (evaluation will be carried out every 12 months).The total study duration will be 4 years after the last patient starts study medication."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Inclusion Criteria:\n\n * ≥18 years, all race/ethnic groups in China；\n * Newly diagnosed and previously untreated (patients are allowed to have received oral prednisone for up to 1 week before enrollment) symptomatic MCD patients (symptomatic disease is defined by the presence of clinical symptoms with the NCI-CTCAE grading ≥1 that are attributable to the disease, and for which treatment is indicated);\n * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2;\n * Clinical laboratory values meeting these criteria at screening: absolute neutrophil count ≥ 1•0 x 109/L, Platelets ≥ 50 x 109/L, Alanine aminotransferase (ALT) within 2•5 x upper limit of normal (ULN); total bilirubin within 2•5 x ULN; estimated glomerular filtration rate (according to MDRD formula) \\<15ml/min;\n * Women of childbearing potential must agree to use birth control measures during the study and for at least 3 months after receiving the last dose of study agent, and must have a negative pregnancy test at screening period. Men must agree to use birth control measures during the study and for at least 3 months after receiving the last dose of study agent;\n * Informed consent must be signed.\n* Exclusion Criteria:\n\n * age under 18 years;\n * ECOG (eastern cooperative oncology group) status above 2;\n * Immunosuppressive or anti-neoplastic drugs within the last 3 months;\n * serious diseases including malignancy;\n * Plan to have babies within 1 year after enrollment (for women and men), or pregnancy / breast-feeding (for women);\n * Known hypersensitivity to study agents;\n * Active infection requiring systemic treatment;\n * Other severe concurrent disease (eg. uncontrolled diabetes, symptomatic coronary heart disease) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study;\n * Unwilling or unable to provide informed consent;\n * Unwilling to return for follow-up at PUMCH.'}, 'identificationModule': {'nctId': 'NCT03043105', 'briefTitle': 'TCP Regimen in Newly Diagnosed MCD:a Prospective, Single-center, Single-arm, Phase-II Pilot Trial', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': "Thalidomide, Cyclophosphamide and Prednisone in Newly Diagnosed Multicentric Castleman's Disease: a Prospective, Single-center, Single-arm, Phase-II Pilot Trial", 'orgStudyIdInfo': {'id': 'ZS-1159'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TCP regimen', 'description': 'Thalidomide, cyclophosphamide and prednisone （TCP regimen）would be used for newly-diagnosed symptomatic MCD patients', 'interventionNames': ['Drug: Thalidomide, cyclophosphamide and prednisone']}], 'interventions': [{'name': 'Thalidomide, cyclophosphamide and prednisone', 'type': 'DRUG', 'otherNames': ['TCP regimen'], 'description': '* Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year;\n* Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year;\n* Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year.', 'armGroupLabels': ['TCP regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100005', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated professor in hematology', 'investigatorFullName': 'Jian Li', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}