Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-01-20 @ 10:15 PM
Study NCT ID:
NCT01569204
Status:
COMPLETED
Last Update Posted:
2018-10-29
First Post:
2012-04-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeted BEACOPP Variants in Patients With Newly Diagnosed Advanced Classical Hodgkin Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006689', 'term': 'Hodgkin Disease'}], 'ancestors': [{'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': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D011344', 'term': 'Procarbazine'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D000079963', 'term': 'Brentuximab Vedotin'}], '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': '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': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'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': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-26', 'studyFirstSubmitDate': '2012-04-02', 'studyFirstSubmitQcDate': '2012-04-02', 'lastUpdatePostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate (RR) after six cycles of chemotherapy', 'timeFrame': '18 weeks'}, {'measure': 'Complete remission rate (CR/CRr) as final treatment outcome after completion of treatment', 'timeFrame': '18 weeks'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': '2 years'}, {'measure': 'Overall survival (OS)', 'timeFrame': '2 years'}, {'measure': 'Adverse event rate', 'timeFrame': '2 years'}, {'measure': 'Dose reduction rate', 'timeFrame': '18 weeks'}, {'measure': 'Relative dose intensity', 'timeFrame': '18 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hodgkin Lymphoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ghsg.org', 'label': 'Homepage GHSG'}]}, 'descriptionModule': {'briefSummary': 'The Purpose of this trial is:\n\n* to determine complete response rate (CRR) after six cycles of chemotherapy\n* to determine complete remission rate (CR/CRr) as final treatment outcome after completion of treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven classical Hodgkin lymphoma\n* First diagnosis, no previous treatment, age: 18-60 years\n* Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV disease\n\nExclusion Criteria:\n\n* Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)\n* Previous malignancy\n* Prior chemotherapy or radiation'}, 'identificationModule': {'nctId': 'NCT01569204', 'briefTitle': 'Targeted BEACOPP Variants in Patients With Newly Diagnosed Advanced Classical Hodgkin Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'orgStudyIdInfo': {'id': 'Targeted BEACOPP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BrECAPP', 'description': 'modified BEACOPP by omitting Bleomycin and adding Brentuximab Vedotin', 'interventionNames': ['Drug: Etoposide', 'Drug: Cyclophosphamide', 'Drug: Doxorubicin', 'Drug: Prednisone', 'Drug: Procarbazine', 'Drug: Brentuximab Vedotin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BrECADD', 'description': 'modified BEACOPP by omitting Bleomycin, Procarbazine and Prednisone and adding Brentuximab Vedotin, Dacarbazine and Dexamethasone', 'interventionNames': ['Drug: Etoposide', 'Drug: Cyclophosphamide', 'Drug: Doxorubicin', 'Drug: Dexamethasone', 'Drug: Dacarbazine', 'Drug: Brentuximab Vedotin']}], 'interventions': [{'name': 'Etoposide', 'type': 'DRUG', 'armGroupLabels': ['BrECADD', 'BrECAPP']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'armGroupLabels': ['BrECADD', 'BrECAPP']}, {'name': 'Doxorubicin', 'type': 'DRUG', 'armGroupLabels': ['BrECADD', 'BrECAPP']}, {'name': 'Prednisone', 'type': 'DRUG', 'armGroupLabels': ['BrECAPP']}, {'name': 'Procarbazine', 'type': 'DRUG', 'armGroupLabels': ['BrECAPP']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'armGroupLabels': ['BrECADD']}, {'name': 'Dacarbazine', 'type': 'DRUG', 'armGroupLabels': ['BrECADD']}, {'name': 'Brentuximab Vedotin', 'type': 'DRUG', 'armGroupLabels': ['BrECADD', 'BrECAPP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cologne', 'country': 'Germany', 'facility': '1st Dept. of Medicine, Cologne University Hospital', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'overallOfficials': [{'name': 'Peter Borchmann, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cologne, German Hodgkin Study Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Prof. Dr. Peter Borchmann', 'investigatorAffiliation': 'University of Cologne'}}}}