Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2026-01-04 @ 2:38 PM
Study NCT ID:
NCT01652261
Status:
WITHDRAWN
Last Update Posted:
2021-02-15
First Post:
2012-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Very Early FDG-PET/CT-response Adapted Therapy for Advanced Hodgkin Lymphoma (H11)
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': 'C034632', 'term': 'ABVD protocol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study closed due to lack of recruitment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-11', 'studyFirstSubmitDate': '2012-07-18', 'studyFirstSubmitQcDate': '2012-07-27', 'lastUpdatePostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from treatment failure', 'timeFrame': '9 years after first patient in (FPI)'}], 'secondaryOutcomes': [{'measure': 'response at the end of therapy', 'timeFrame': '9 years after FPI'}, {'measure': 'Progression-free survival', 'timeFrame': '9 years after FPI'}, {'measure': 'Overall survival', 'timeFrame': '9 years after FPI'}, {'measure': 'Acute toxicity', 'timeFrame': '9 years after FPI', 'description': '* Hematological toxicity (blood cell count) can be significant especially for patients who will receive BEACOPPesc .\n* Bleomycine interstitial pneumonitis has been frequently reported and requires the immediate stop of further bleomycine administration.\n* Rarely, procarbazine allergy and intolerance has been reported.\n* Nausea \\& vomiting due to cyclophosphamide, doxorubicin, dacarbazine and procarbazine may be significant.\n* Total reversible alopecia occurs in most cases.\n* Escalated BEACOPP-related toxic deaths have been reported but do not exceed those observed with standard ABVD.'}, {'measure': 'Long-term toxicity in terms of second malignancies, cardiovascular and pulmonary events', 'timeFrame': '9 years after FPI'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['advanced stage'], 'conditions': ['Hodgkin Lymphoma']}, 'referencesModule': {'references': [{'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.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of the trial is to show that doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD)-based response-adapted therapy for advanced-stage Hodgkin lymphoma, with treatment intensification (bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPPesc) in case of a positive fluorodeoxyglucose (FDG) positron emission tomography (PET) computed tomography (CT) after one cycle of ABVD, has non-inferior efficacy compared with the intensive BEACOPPesc regimen. A second objective is to assess the prognostic value of FDG-PET/CT after one cycle of BEACOPPesc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Previously untreated, histologically proven classical Hodgkin lymphoma\n* Clinical stages III/IV (Ann Arbor)\n* Age 18-60\n* WHO performance 0-2\n* Adequate organ function\n* Patients of childbearing/reproductive potential should use adequate birth control measures during the whole duration of study treatment.\n* Written informed consent according to ICH/EU Good Clinical Practice, and national/local regulations\n\nExclusion criteria:\n\n* Pregnancy or lactation\n* Specific contraindications to BEACOPPesc therapy, including:\n* Poorly controlled diabetes mellitus\n* HIV infection,\n* Chronic active hepatitis B and/or hepatitis C\n* Concomitant or previous malignancies with the exception of basal cell skin tumors, adequately treated carcinoma in situ of the cervix and any cancer that has been in complete remission for \\>5 years\n* Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial'}, 'identificationModule': {'nctId': 'NCT01652261', 'acronym': 'H11', 'briefTitle': 'Very Early FDG-PET/CT-response Adapted Therapy for Advanced Hodgkin Lymphoma (H11)', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': 'Very Early FDG-PET/CT-response Adapted Therapy for Advanced Stage Hodgkin Lymphoma, a Randomized Phase III Non-inferiority Study of the EORTC Lymphoma Group', 'orgStudyIdInfo': {'id': 'EORTC-20101-23101'}, 'secondaryIdInfos': [{'id': '2011-005473-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental arm', 'description': 'An experimental arm (early FDG-PET/CT-response adapted), where all patients are initially treated with a single cycle of ABVD. Very early FDG-PET/CT-negative patients continue on ABVD therapy to a total of six cycles. Very early FDG-PET/CT-positive patients receive 3 cycles of BEACOPPesc followed by another 3 cycles of BEACOPPesc. Mid-treatment evaluation is performed after 4 cycles. In case of treatment failure (less than partial remission (PR)), the patient goes off protocol treatment.\n\nOnly patients with residual FDG-PET/CT-positive disease after chemotherapy will receive radiotherapy (36 Gy/18 fractions on the FDG-PET/CT-positive residual mass(es)).', 'interventionNames': ['Drug: ABVD + FDG-PET/CT Scan treatment adaptation', 'Drug: BEACOPPesc']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard arm', 'description': 'A standard arm, where patients are treated with four cycles of BEACOPPesc followed by 2 cycles of BEACOPPesc. FDG-PET/CT is performed after one cycle, but with no therapeutic consequences. Mid-treatment evaluation is performed after four cycles. In case of treatment failure (less than PR), the patient goes off protocol treatment.\n\nOnly patients with residual FDG-PET/CT-positive disease after chemotherapy will receive radiotherapy (36 Gy/18 fractions on the FDG-PET/CT-positive residual mass(es)).', 'interventionNames': ['Drug: BEACOPPesc']}], 'interventions': [{'name': 'ABVD + FDG-PET/CT Scan treatment adaptation', 'type': 'DRUG', 'armGroupLabels': ['experimental arm']}, {'name': 'BEACOPPesc', 'type': 'DRUG', 'armGroupLabels': ['experimental arm', 'standard arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Martin Hutchings', 'role': 'STUDY_CHAIR', 'affiliation': 'Rigshospitalet, Denmark'}, {'name': 'Berthe Aleman', 'role': 'STUDY_CHAIR', 'affiliation': 'The Netherlands Cancer Institute, Amsterdam, The Netherlands'}, {'name': 'Gustaaf van IMHOFF', 'role': 'STUDY_CHAIR', 'affiliation': 'University Medical Center Groningen'}, {'name': 'Wim Oyen', 'role': 'STUDY_CHAIR', 'affiliation': 'Radboud University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Polish Lymphoma Research Group', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}