Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2026-01-27 @ 3:37 PM
Study NCT ID:
NCT01088750
Status:
COMPLETED
Last Update Posted:
2023-12-13
First Post:
2010-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgery Alone or With CYC VBL and PRED or CVP Alone in Stage IA or IIA Nodular Lymphocyte-Predominant Hodgkin Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}], 'ancestors': [{'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': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'C036266', 'term': 'prednylidene'}, {'id': 'D014747', 'term': 'Vinblastine'}, {'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'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': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic 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': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 225}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-06', 'studyFirstSubmitDate': '2010-03-16', 'studyFirstSubmitQcDate': '2010-03-16', 'lastUpdatePostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-free survival', 'timeFrame': '5 years', 'description': 'Time from treatment start until relapse/progression, secondary malignancy or death'}], 'secondaryOutcomes': [{'measure': 'Significant upstaging at relapse defined as development of B-symptoms, extranodal disease, or relapse higher than stage II', 'timeFrame': '5 years', 'description': 'Stage greater than IIA at relapse diagnosis'}, {'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'Time from treatment start until death'}, {'measure': 'Common Toxicity criteria toxicity Levels of therapy elements', 'timeFrame': '5 years', 'description': 'Evaluation of AEs, SAEs atc. according to CTC'}, {'measure': 'Complications of surgery', 'timeFrame': '5 years', 'description': 'Listing of surgical complications'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['childhood nodular lymphocyte predominant Hodgkin lymphoma', 'stage I childhood Hodgkin lymphoma', 'stage II childhood Hodgkin lymphoma'], 'conditions': ['Lymphoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.cancer.gov/about-cancer/treatment/clinical-trials/search/v?a=8&id=NCI-2014-02026&loc=0&rl=2&st=C7258&t=C9357', 'label': "Clinical trial summary from the National Cancer Institute's PDQ® database"}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, vinblastine, and prednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Surgery to remove involved lymph nodes may be an effective treatment for young patients with nodular lymphocyte-predominant Hodgkin lymphoma.\n\nPURPOSE: This phase IV trial is continuing to study the side effects of giving surgery alone or giving surgery with cyclophosphamide, vinblastine, and prednisolone compared with giving cyclophosphamide, vinblastine, and prednisolone alone in treating young patients with stage IA or stage IIA nodular lymphocyte-predominant Hodgkin lymphoma.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the 5-year event-free survival of children or adolescents with stage IA or IIA nodular lymphocyte-predominant Hodgkin lymphoma treated with surgery alone or with cyclophosphamide, vinblastine, and prednisolone.\n\nSecondary\n\n* Determine if this regimen results in a decrease in overall survival rates, in significant upstaging at relapse, or increased rates of histological transformation in these patients.\n\nOUTLINE:\n\n* Group 1 (patients with stage IA disease only): Patients undergo surgical resection of the involved lymph nodes. Patients who achieve complete resection then enter follow-up (watch and wait); patients who do not achieve complete resection enters group 2 treatment.\n* Group 2 (patients with stage IIA disease or incompletely resected stage IA disease): Patients receive cyclophosphamide, vinblastine, and prednisolone for 3 courses. Patients with good response enter follow-up (watch and wait). Patients without a good response are taken off protocol.\n\nAfter completion of study treatment, patients are followed-up periodically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* nodular lymphocyte-predominant Hodgkin's lymphoma confirmed by reference pathology.\n* initial stage IA/IIA (according to local staging) or relapse stage IA or IIA and residual tumour after relapse biopsy and no additional surgery planned in nLP patients relapsing after surgery alone\n* patient aged under 18 years at time of diagnosis\n* written informed consent of the patient and/or the patient's parents or guardian according to national laws\n\nExclusion criteria\n\n* pre-treatment of Hodgkin's lymphoma differing from study protocol\n* Any extra-nodal involvement\n* Inability to fulfil protocol requirements for imaging (CT, MRI, FDG-PET) at staging and response assessment\n* known hypersensitivity or contraindication to study drugs\n* prior chemotherapy or radiotherapy\n* Current or recent therapy (within 30 days prior to the start of trial treatment) with steroids\n* Current or recent (within 30 days prior to the start of trial treatment) treatment with another investigational drug or participation in another investigational trial\n* other (simultaneous) malignancies\n* severe concomitant diseases (e.g. immune deficiency syndrome)\n* known HIV positivity\n* pregnancy and / or lactation\n* females who are sexually active refusing to use effective contraception (oral contraception, intrauterine devices, barrier method of contraception in conjunction with spermicidal jelly or surgical sterile) (except for surgery only)"}, 'identificationModule': {'nctId': 'NCT01088750', 'acronym': 'EuroNetLP1', 'briefTitle': 'Surgery Alone or With CYC VBL and PRED or CVP Alone in Stage IA or IIA Nodular Lymphocyte-Predominant Hodgkin Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Martin-Luther-Universität Halle-Wittenberg'}, 'officialTitle': "First International Inter-Group Study for Nodular Lymphocyte-Predominant Hodgkin's Lymphoma in Children and Adolescents", 'orgStudyIdInfo': {'id': 'CDR0000667369'}, 'secondaryIdInfos': [{'id': '2007-004092-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'surgery alone', 'description': 'watch and wait strategy after complete resection of localised (e.g. Stage IA) nodular lymphocyte-predominant HL', 'interventionNames': ['Other: watchful waiting', 'Procedure: therapeutic conventional surgery']}, {'type': 'EXPERIMENTAL', 'label': 'CVP Chemotherapy', 'description': '3 cycles of intensity-reduced, anthracycline-free chemotherapy (Cyclophosphamide, vinblastine and prednisone)', 'interventionNames': ['Drug: cyclophosphamide', 'Drug: prednisolone', 'Drug: vinblastine sulfate']}], 'interventions': [{'name': 'cyclophosphamide', 'type': 'DRUG', 'otherNames': ['CYC'], 'armGroupLabels': ['CVP Chemotherapy']}, {'name': 'prednisolone', 'type': 'DRUG', 'otherNames': ['PRED'], 'armGroupLabels': ['CVP Chemotherapy']}, {'name': 'vinblastine sulfate', 'type': 'DRUG', 'otherNames': ['VBL'], 'armGroupLabels': ['CVP Chemotherapy']}, {'name': 'watchful waiting', 'type': 'OTHER', 'armGroupLabels': ['surgery alone']}, {'name': 'therapeutic conventional surgery', 'type': 'PROCEDURE', 'armGroupLabels': ['surgery alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-35385', 'city': 'Giessen', 'country': 'Germany', 'facility': 'Universitaetsklinikum Giessen-Marburg', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}], 'overallOfficials': [{'name': 'Dieter Koerholz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaetsklinikum Giessen und Marburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christine Mauz-Körholz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Deutsche Krebshilfe e.V., Bonn (Germany)', 'class': 'OTHER'}, {'name': 'Euronet Worldwide', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Christine Mauz-Körholz', 'investigatorFullName': 'Christine Mauz-Körholz', 'investigatorAffiliation': 'Martin-Luther-Universität Halle-Wittenberg'}}}}