Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-01-22 @ 5:35 PM
Study NCT ID:
NCT02661503
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2016-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HD21 for Advanced Stages
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001761', 'term': 'Bleomycin'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D011344', 'term': 'Procarbazine'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D000079963', 'term': 'Brentuximab Vedotin'}, {'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'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': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'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': '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': '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': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'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'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1500}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-10', 'studyFirstSubmitDate': '2016-01-19', 'studyFirstSubmitQcDate': '2016-01-19', 'lastUpdatePostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': '5 years'}, {'measure': 'Treatment Related Morbidity', 'timeFrame': 'during 6 cycles of chemotherapy (21-day cycles)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Classical Hodgkin Lymphoma']}, 'referencesModule': {'references': [{'pmid': '40674676', 'type': 'DERIVED', 'citation': 'Ferdinandus J, Kaul H, Fossa A, Huttmann A, Keil F, Ko YD, Hitz F, Schwarz M, Trenker C, Kerkhoff A, Staib P, Wille K, Dresel I, Hahn D, Hertenstein B, Moosmann P, Mey U, Balabanov S, Armytage T, Roncolato F, Hellmuth JC, Hertzberg M, Kobe C, Klapper W, Baues C, Eich HT, Kreissl S, Fuchs M, Jablonski J, Schneider G, Tharmaseelan H, Eichenauer DA, von Tresckow B, Borchmann P, Brockelmann PJ. Positron Emission Tomography-Guided Brentuximab Vedotin, Etoposide, Cyclophosphamide, Doxorubicin, Dacarbazine, and Dexamethasone in Older Patients With Advanced-Stage Classic Hodgkin Lymphoma: A Prospective, Multicenter, Single-Arm, Phase II Cohort of the German Hodgkin Study Group HD21 Trial. J Clin Oncol. 2025 Sep 20;43(27):2974-2985. doi: 10.1200/JCO-25-00439. Epub 2025 Jul 17.'}, {'pmid': '40652943', 'type': 'DERIVED', 'citation': 'Ferdinandus J, Schneider G, Moccia A, Greil R, Hertzberg M, Schaub V, Huttmann A, Keil F, Dierlamm J, Hanel M, Novak U, Meissner J, Hellmuth JC, Mathas S, Zijlstra JM, Fossa A, Viardot A, Hertenstein B, Martin S, Giri P, Kamper P, Molin D, Jablonski J, Damaschin C, Robertz AS, Rosenbrock J, Fuchs M, Borchmann P, Behringer K. Fertility in patients with advanced-stage classic Hodgkin lymphoma treated with BrECADD versus eBEACOPP: a secondary analysis of the multicentre, randomised, parallel, open-label, phase 3 HD21 trial. Lancet Oncol. 2025 Aug;26(8):1081-1090. doi: 10.1016/S1470-2045(25)00262-1. Epub 2025 Jul 10.'}, {'pmid': '40135712', 'type': 'DERIVED', 'citation': 'Kreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3.'}, {'pmid': '38971175', 'type': 'DERIVED', 'citation': 'Borchmann P, Ferdinandus J, Schneider G, Moccia A, Greil R, Hertzberg M, Schaub V, Huttmann A, Keil F, Dierlamm J, Hanel M, Novak U, Meissner J, Zimmermann A, Mathas S, Zijlstra JM, Fossa A, Viardot A, Hertenstein B, Martin S, Giri P, Scholl S, Topp MS, Jung W, Vucinic V, Beck HJ, Kerkhoff A, Unger B, Rank A, Schroers R, Zum Buschenfelde CM, de Wit M, Trautmann-Grill K, Kamper P, Molin D, Kreissl S, Kaul H, von Tresckow B, Borchmann S, Behringer K, Fuchs M, Rosenwald A, Klapper W, Eich HT, Baues C, Zomas A, Hallek M, Dietlein M, Kobe C, Diehl V; German Hodgkin Study Group; Swiss Group for Clinical Cancer Research; Arbeitsgemeinschaft Medikamentose Tumortherapie; Nordic Lymphoma Group; Australasian Leukaemia and Lymphoma Group. Assessing the efficacy and tolerability of PET-guided BrECADD versus eBEACOPP in advanced-stage, classical Hodgkin lymphoma (HD21): a randomised, multicentre, parallel, open-label, phase 3 trial. Lancet. 2024 Jul 27;404(10450):341-352. doi: 10.1016/S0140-6736(24)01315-1. Epub 2024 Jul 3.'}]}, 'descriptionModule': {'briefSummary': 'Primary objective of the trial is to demonstrate non-inferior efficacy of six cycles of BrECADD compared to six cycles of escalated BEACOPP, each followed by radiotherapy to PET-positive residual lesions ≥2.5 cm, in terms of progression free survival (efficacy objective).\n\nIf non-inferior efficacy can be shown, the co-primary objective is to further demonstrate reduced toxicity of the BrECADD treatment compared to the escalated BEACOPP treatment measured by treatment related morbidity (TRMorbidity objective).'}, '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, 18 to 60 years of age\n* Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV\n\nExclusion Criteria:\n\n* Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma\n* Previous malignancy (exceptions: basalioma, carcinoma in situ of the cervix uteri, completely resected melanoma TNMpT1)\n* Prior chemotherapy or radiotherapy'}, 'identificationModule': {'nctId': 'NCT02661503', 'briefTitle': 'HD21 for Advanced Stages', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'HD21 for Advanced Stages Treatment Optimization Trial in the First-line Treatment of Advanced Stage Hodgkin Lymphoma; Comparison of 6 Cycles of Escalated BEACOPP With 6 Cycles of BrECADD', 'orgStudyIdInfo': {'id': 'Uni-Koeln-1762'}, 'secondaryIdInfos': [{'id': '2014-005130-55', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BEACOPP', 'description': '4 or 6 cycles of BEACOPP (21-day cycles) Bleomycin (B) Etoposide (E) Doxorubicin (A) Cyclophosphamide (C) Vincristine (O) Procarbazin (P) Prednisone (P). If FDG-PET is negative after two cycles patients will be given a total of four cycles. If FDG-PET is positive after two cycles patients will bev given a total of six cycles.', 'interventionNames': ['Drug: Bleomycin', 'Drug: Etoposide', 'Drug: Doxorubicin', 'Drug: Cyclophosphamide', 'Drug: Vincristine', 'Drug: Procarbazine', 'Drug: Prednisone']}, {'type': 'EXPERIMENTAL', 'label': 'BRECADD', 'description': '4 or 6 cycles of BRECADD (21.day cycles) Brentuximab Vedotin (BR) Etoposide (E) Cyclophosphamide (C) Doxorubicin (A) Dacarbazine (D) Dexamethasone (D). If FDG-PET is negative after two cycles patients will be given a total of four cycles. If FDG-PET is positive after two cycles patients will be given a total of six cycles.', 'interventionNames': ['Drug: Etoposide', 'Drug: Doxorubicin', 'Drug: Cyclophosphamide', 'Drug: Brentuximab Vedotin', 'Drug: Dacarbazine', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'Bleomycin', 'type': 'DRUG', 'armGroupLabels': ['BEACOPP']}, {'name': 'Etoposide', 'type': 'DRUG', 'armGroupLabels': ['BEACOPP', 'BRECADD']}, {'name': 'Doxorubicin', 'type': 'DRUG', 'armGroupLabels': ['BEACOPP', 'BRECADD']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'armGroupLabels': ['BEACOPP', 'BRECADD']}, {'name': 'Vincristine', 'type': 'DRUG', 'armGroupLabels': ['BEACOPP']}, {'name': 'Procarbazine', 'type': 'DRUG', 'armGroupLabels': ['BEACOPP']}, {'name': 'Prednisone', 'type': 'DRUG', 'armGroupLabels': ['BEACOPP']}, {'name': 'Brentuximab Vedotin', 'type': 'DRUG', 'armGroupLabels': ['BRECADD']}, {'name': 'Dacarbazine', 'type': 'DRUG', 'armGroupLabels': ['BRECADD']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'armGroupLabels': ['BRECADD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cologne', 'country': 'Germany', 'facility': 'University Hospital of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'overallOfficials': [{'name': 'Peter Borchmann, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cologne, I. Dept. of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Prof. Dr. Peter Borchmann', 'investigatorAffiliation': 'University of Cologne'}}}}