Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-02 @ 5:50 PM
Study NCT ID:
NCT02858804
Status:
UNKNOWN
Last Update Posted:
2019-06-14
First Post:
2016-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EDOCH Alternating With DHAP for New Diagnosed Younger MCL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}], 'ancestors': [{'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': 'D005047', 'term': 'Etoposide'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D013792', 'term': 'Thalidomide'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'C036266', 'term': 'prednylidene'}], 'ancestors': [{'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'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': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum 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': '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': 'D054833', 'term': 'Isoindoles'}, {'id': 'D011244', 'term': 'Pregnadienediols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-13', 'studyFirstSubmitDate': '2016-07-17', 'studyFirstSubmitQcDate': '2016-08-03', 'lastUpdatePostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': 'up to 36 months', 'description': 'the time interval between diagnosis and disease progression or death or last follow-up'}], 'secondaryOutcomes': [{'measure': 'complete remission', 'timeFrame': 'up to 6 months', 'description': 'measure with normal serum immunofixation electrophoresis and normal bone marrow feature, and without symptoms and enlarged organs'}, {'measure': 'overall survival', 'timeFrame': 'up to 36 months', 'description': 'time interval between diagnosis and death or last follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mantle cell lymphoma', 'EDOCH', 'DHAP', 'maintenance therapy'], 'conditions': ['Mantle Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to:\n\n1. determine the efficiency of EDOCH (etoposide,dexamethasone,doxorubicin, cyclophosphamide and vincristine) alternating with DHAP (cisplatin, cytarabine and dexamethasone) regimen combined with rituximab or not in young mantle cell lymphoma patients (age≤65 years);\n2. determine the efficiency of rituximab and thalidomide plus prednisone as maintenance regimens.', 'detailedDescription': "Enrolled patients will receive EDOCH (etoposide,dexamethasone,doxorubicin, cyclophosphamide and vincristine) ±R /DHAP(cisplatin, cytarabine and dexamethasone) ±R alternating chemotherapy. If a partial remission or better response achieves, patients will be recommended to receive autologous stem cell transplantation as consideration therapy or another two cycles EDOCH ±R /DHAP±R chemotherapy (based on patient's choice). Patients with less than partial remission (PR) response will quit this study. After treatments finished, maintenance therapy with rituximab or thalidomide plus prednisone will be given less than two years. The determination of maintenance regimens is dependent on patients choices."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age≤65 years\n* diagnosis with mantle cell lymphoma\n* Ann Arbor stage II,III or IV\n* ECOG≤1 or if ECOG≥2 but recover after pretreatment.\n\nExclusion Criteria:\n\n* with centre neural system involvement\n* serious complications such as uncontrolled diabetes, gastric ulcer or other serious angiocardiopathy determined by the physician\n* HIV positive or active HBV infection or other uncontrolled systematic infection\n* clinical central nervous dysfunction\n* serious surgery within 30 days\n* pregnancy or baby nursing period or un-contracepted child bearing period woman.'}, 'identificationModule': {'nctId': 'NCT02858804', 'acronym': 'BDH-MCL01', 'briefTitle': 'EDOCH Alternating With DHAP for New Diagnosed Younger MCL', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Hematology & Blood Diseases Hospital, China'}, 'officialTitle': 'EDOCH Alternating With DHAP Regimen Combined Rituximab or Not to Treat New Diagnosed Younger (Age≤65 Years) Mantle Cell Lymphoma in China: A Multicentre Phase III Trial', 'orgStudyIdInfo': {'id': 'IIT2015007-EC-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Etoposide', 'description': '50 mg/m2, IV, d1-4', 'interventionNames': ['Drug: Etoposide']}, {'type': 'EXPERIMENTAL', 'label': 'Doxorubicin', 'description': '10 mg/m2, IV, d1-4', 'interventionNames': ['Drug: Doxorubicin']}, {'type': 'EXPERIMENTAL', 'label': 'Dexamethasone', 'description': '30 mg/d, d1-5', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'Vincristine', 'description': '0.4 mg/m2, IV, d1-4', 'interventionNames': ['Drug: Vincristine']}, {'type': 'EXPERIMENTAL', 'label': 'Cyclophosphamide', 'description': '750 mg/m2 ,d5', 'interventionNames': ['Drug: Cyclophosphamide']}, {'type': 'EXPERIMENTAL', 'label': 'Cytarabine', 'description': '2g/m2, q12h, d1', 'interventionNames': ['Drug: Cytarabine']}, {'type': 'EXPERIMENTAL', 'label': 'Cisplatin', 'description': '100mg/ m2,IV, d1', 'interventionNames': ['Drug: Cisplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Rituximab', 'description': '375 mg/m2 IV, d1', 'interventionNames': ['Drug: Rituximab']}, {'type': 'EXPERIMENTAL', 'label': 'Thalidomide', 'description': '50-150mg/d, po, d1-28', 'interventionNames': ['Drug: Thalidomide']}, {'type': 'EXPERIMENTAL', 'label': 'Prednisone', 'description': '0.5mg/Kg, po, qod', 'interventionNames': ['Drug: Prednisone']}], 'interventions': [{'name': 'Etoposide', 'type': 'DRUG', 'otherNames': ['VP-16'], 'description': '50 mg/m2, IV d1-4', 'armGroupLabels': ['Etoposide']}, {'name': 'Doxorubicin', 'type': 'DRUG', 'otherNames': ['adriamycin'], 'description': '10 mg/m2, IV, d1-4', 'armGroupLabels': ['Doxorubicin']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Dex'], 'description': '30 mg/d, d1-5', 'armGroupLabels': ['Dexamethasone']}, {'name': 'Vincristine', 'type': 'DRUG', 'otherNames': ['VCR'], 'description': '0.4 mg/m2, IV, d1-4', 'armGroupLabels': ['Vincristine']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['CTX'], 'description': '750 mg/m2 ,d5', 'armGroupLabels': ['Cyclophosphamide']}, {'name': 'Cytarabine', 'type': 'DRUG', 'otherNames': ['Ara-c'], 'description': '2g/m2, q12h, d1', 'armGroupLabels': ['Cytarabine']}, {'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['DDP'], 'description': '100mg/ m2,IV, d1', 'armGroupLabels': ['Cisplatin']}, {'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['R'], 'description': '375 mg/m2 IV, d1', 'armGroupLabels': ['Rituximab']}, {'name': 'Thalidomide', 'type': 'DRUG', 'otherNames': ['Thal'], 'description': '50-150mg/d, po, d1-28', 'armGroupLabels': ['Thalidomide']}, {'name': 'Prednisone', 'type': 'DRUG', 'otherNames': ['Pred'], 'description': '0.5mg/Kg, po, qod', 'armGroupLabels': ['Prednisone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300020', 'city': 'Tianjin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuhua Yi, Doc', 'role': 'CONTACT', 'email': 'yishuhua@ihcams.ac.cn', 'phone': '86-22-23909106'}, {'name': 'Lugui Qiu, Doc', 'role': 'CONTACT', 'email': 'qiulg@ihcams.ac.cn', 'phone': '86-22-23909172'}], 'facility': 'Shuhua Yi', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Shuhua Yi, Doc', 'role': 'CONTACT', 'email': 'yishuhua@ihcams.ac.cn', 'phone': '86-22-23909106'}, {'name': 'Lugui Qiu, Doc', 'role': 'CONTACT', 'email': 'qiulg@ihcams.ac.cn', 'phone': '86-22-23909172'}], 'overallOfficials': [{'name': 'Shuhua Yi, Doc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Blood disease hospital, Chinese Academic Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Hematology & Blood Diseases Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yi Shuhua', 'investigatorAffiliation': 'Institute of Hematology & Blood Diseases Hospital, China'}}}}