Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-28 @ 3:58 PM
Study NCT ID:
NCT01195766
Status:
COMPLETED
Last Update Posted:
2016-02-24
First Post:
2010-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Ofatumumab and ESHAP for the Treatment of Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D008223', 'term': 'Lymphoma'}], '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': 'C527517', 'term': 'ofatumumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-23', 'studyFirstSubmitDate': '2010-09-03', 'studyFirstSubmitQcDate': '2010-09-03', 'lastUpdatePostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of the global response rate (complete responses + partial responses) after O-ESHAP treatment', 'timeFrame': '4 years follow-up'}], 'secondaryOutcomes': [{'measure': 'To analyze the complete response rate after O-ESHAP treatment. Further secondary outcomes as described in study summary', 'timeFrame': '4 years follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hodgkin', 'Ofatumumab', 'Lymphoma'], 'conditions': ['Hodgkin Disease']}, 'descriptionModule': {'briefSummary': "The aim of this study is to analyze the efficacy of O-ESHAP treatment for Hodgkin's lymphome patients that have a first line chemotherapy treatment failure due to refractoriness, partial response or relapsed.\n\nIn the same way, mortality, global survival and free-progression survival after O-ESHAP treatment and TAPH will also analyzed.", 'detailedDescription': 'In addition to the above:\n\n* To asses the complete response rate after O-ESHAP.\n* To asses the toxicity of O-ESHAP regimen\n* To asses the stem cells mobilization capacity of O-ESHAP regimen\n* To evaluate the final results of the whole procedure (O-ESHAP followed by high-dose chemotherapy and ASCT): transplant-related mortality (TRM), overall survival (OS), and progression free survival (PFS)\n* To investigate the correlation between the overall response and CD20 expression by tumoral cells.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histologically confirmed relapsed, partial response or refractory classical HL after first line chemotherapy. They will be included irrespective of CD20 expression on HRS cells. CD20 expression will be analyzed on all available biopsies and this data will be recorded for further evaluation.\n* Age 18 to 65 years. Patient \\>65 and \\<70 years old with ECOG \\< 2 and absence of comorbidities will be included in the study if considered adequate by the investigator.\n* Leucocytes \\> 3,0 x 109/L and platelets \\> 100 x 109/L.\n* ECOG \\< 2.\n* No major organ dysfunction.\n* Written informed consent.\n* HIV negative.\n* No active hepatitis B or C infection.\n* Availability of histological report of biopsy at diagnosis or at relapse and availability of biopsy to be revised by reference pathologists.\n* Absence of other neoplasia, except basocellular tumor or carcinoma of the uterine cervix in situ.\n* Contraception measures in fertile females.\n\nExclusion Criteria:\n\n* Subjects who have current active hepatic or biliary disease\n* presence of pathology that would contraindicate the administration of chemotherapy\n* HIV positive\n* Hepatitis B or C infection\n* history of other malignancies in addition to those specified in the inclusion criteria\n* informed consent not signed\n* Pregnant and / or breast-feeding or reproductive capacity adults who do not use an effective method of birth control during study treatment and at least six months later. An effective method is that used at least one barrier mechanism.'}, 'identificationModule': {'nctId': 'NCT01195766', 'briefTitle': "Study of Ofatumumab and ESHAP for the Treatment of Hodgkin's Lymphoma", 'organization': {'class': 'OTHER', 'fullName': 'Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea'}, 'officialTitle': "Phase II-study Using Ofatumumab and ESHAP Followed by Autologous Trasplant of Hemopoietic Precursors for the Treatment of Classic Hodgkin's Lymphoma on Relapse, Partial Response or Refractory to First Line Treatment", 'orgStudyIdInfo': {'id': 'O-ESHAP-LH-2009'}, 'secondaryIdInfos': [{'id': '2009-016026-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ofatumumab', 'description': 'Ofatumumab in addition to ESHAP therapy', 'interventionNames': ['Drug: Ofatumumab']}], 'interventions': [{'name': 'Ofatumumab', 'type': 'DRUG', 'otherNames': ['ARZERRA'], 'description': 'Ofatumumab in addition with ESHAP therapy', 'armGroupLabels': ['Ofatumumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08025', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Instituto Catalan de Oncologia', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '28040', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clinico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Ramon y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'state': 'Malaga', 'country': 'Spain', 'facility': 'Hospital Carlos Haya', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '07010', 'city': 'Palma de Mallorca', 'state': 'Mallorca', 'country': 'Spain', 'facility': 'Hospital Son Espases', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '30008', 'city': 'Murcia', 'state': 'Murcia', 'country': 'Spain', 'facility': 'Hospital Morales Messeguer', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Hospital de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '37007', 'city': 'Salamanca', 'state': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Clinico de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '38320', 'city': 'Santa Cruz de Tenerife', 'state': 'Tenerife', 'country': 'Spain', 'facility': 'Hospital Universitario de Canarias', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'zip': '46010', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clinico de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '47012', 'city': 'Valladolid', 'state': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Rio Hortega', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}], 'overallOfficials': [{'name': 'Carmen Martínez, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Clinic i provincial de Barcelona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}