Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-01-09 @ 7:07 AM
Study NCT ID:
NCT03004833
Status:
COMPLETED
Last Update Posted:
2025-04-03
First Post:
2016-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D014747', 'term': 'Vinblastine'}, {'id': 'D003606', 'term': 'Dacarbazine'}], 'ancestors': [{'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': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'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': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'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': 'D014226', 'term': 'Triazenes'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2016-11-07', 'studyFirstSubmitQcDate': '2016-12-28', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Remission Rate', 'timeFrame': '4 to 6 weeks after end of treatment'}], 'secondaryOutcomes': [{'measure': 'Treatment related Morbidity', 'timeFrame': '1 year after end of treatment'}, {'measure': 'Progression Free Survival', 'timeFrame': '1 and 3 years after end of treatment'}, {'measure': 'Overall Survival', 'timeFrame': '1 and 3 years after end of treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Classical Hodgkin Lymphoma']}, 'referencesModule': {'references': [{'pmid': '36508302', 'type': 'DERIVED', 'citation': 'Brockelmann PJ, Buhnen I, Meissner J, Trautmann-Grill K, Herhaus P, Halbsguth TV, Schaub V, Kerkhoff A, Mathas S, Bormann M, Dickhut A, Kaul H, Fuchs M, Kobe C, Baues C, Borchmann P, Engert A, von Tresckow B. Nivolumab and Doxorubicin, Vinblastine, and Dacarbazine in Early-Stage Unfavorable Hodgkin Lymphoma: Final Analysis of the Randomized German Hodgkin Study Group Phase II NIVAHL Trial. J Clin Oncol. 2023 Feb 20;41(6):1193-1199. doi: 10.1200/JCO.22.02355. Epub 2022 Dec 12.'}, {'pmid': '34520052', 'type': 'DERIVED', 'citation': 'Gerhard-Hartmann E, Goergen H, Brockelmann PJ, Mottok A, Steinmuller T, Grund J, Zamo A, Ben-Neriah S, Sasse S, Borchmann S, Fuchs M, Borchmann P, Reinke S, Engert A, Veldman J, Diepstra A, Klapper W, Rosenwald A. 9p24.1 alterations and programmed cell death 1 ligand 1 expression in early stage unfavourable classical Hodgkin lymphoma: an analysis from the German Hodgkin Study Group NIVAHL trial. Br J Haematol. 2022 Jan;196(1):116-126. doi: 10.1111/bjh.17793. Epub 2021 Sep 14.'}, {'pmid': '32352505', 'type': 'DERIVED', 'citation': 'Brockelmann PJ, Goergen H, Keller U, Meissner J, Ordemann R, Halbsguth TV, Sasse S, Sokler M, Kerkhoff A, Mathas S, Huttmann A, Bormann M, Zimmermann A, Mettler J, Fuchs M, von Tresckow B, Baues C, Rosenwald A, Klapper W, Kobe C, Borchmann P, Engert A. Efficacy of Nivolumab and AVD in Early-Stage Unfavorable Classic Hodgkin Lymphoma: The Randomized Phase 2 German Hodgkin Study Group NIVAHL Trial. JAMA Oncol. 2020 Jun 1;6(6):872-880. doi: 10.1001/jamaoncol.2020.0750.'}], 'seeAlsoLinks': [{'url': 'http://www.ghsg.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The aim of the trial is to improve first-line treatment for early unfavorable cHL by introduction of the anti-PD-1 antibody Nivolumab with a truncated standard chemotherapy (AVD).\n\nThe primary objective is to show efficacy of the two experimental treatment strategies. Secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven classical HL\n* First diagnosis, no previous treatment\n* Age: 18-60 years\n* Stage I, IIA with risk factors a-d, IIB with RF c-d:\n\n 1. large mediastinal mass\n 2. extranodal lesions\n 3. elevated ESR\n 4. ≥ 3 nodal areas confirmed by central review.\n\nExclusion Criteria:\n\n* Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)\n* History of other malignancy ≤ 5 years\n* Prior chemotherapy or radiation therapy\n* Concurrent disease precluding protocol treatment\n* Pregnancy, lactation\n* Non-compliance'}, 'identificationModule': {'nctId': 'NCT03004833', 'acronym': 'NIVAHL', 'briefTitle': 'Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma', 'orgStudyIdInfo': {'id': 'Uni-Koeln-2854'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': '4 Cycles of Nivolumab plus AVD followed by IF-RT (30 Gy)', 'interventionNames': ['Drug: Nivolumab', 'Drug: Adriamycin', 'Drug: Vinblastine', 'Drug: Dacarbazine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': '4 Cycles of Nivolumab, followed by 2 cycles of Nivolumab plus AVD, followed by 2 Cycles of AVD followed by IF-RT (30 Gy)', 'interventionNames': ['Drug: Nivolumab', 'Drug: Adriamycin', 'Drug: Vinblastine', 'Drug: Dacarbazine']}], 'interventions': [{'name': 'Nivolumab', 'type': 'DRUG', 'description': 'Infusion of Nivolumab', 'armGroupLabels': ['Arm A', 'Arm B']}, {'name': 'Adriamycin', 'type': 'DRUG', 'description': 'Infusion of Adriamycin', 'armGroupLabels': ['Arm A', 'Arm B']}, {'name': 'Vinblastine', 'type': 'DRUG', 'description': 'Infusion of Vinblastine', 'armGroupLabels': ['Arm A', 'Arm B']}, {'name': 'Dacarbazine', 'type': 'DRUG', 'description': 'Infusion of Dacarbazine', 'armGroupLabels': ['Arm A', 'Arm B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cologne', 'country': 'Germany', 'facility': 'University Hospital of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'overallOfficials': [{'name': 'Andreas Engert, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cologne, I. Dept. of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Dr. Paul Broeckelmann', 'investigatorAffiliation': 'University of Cologne'}}}}