Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-02-25 @ 6:57 PM
Study NCT ID:
NCT01453504
Status:
COMPLETED
Last Update Posted:
2019-11-08
First Post:
2011-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Everolimus in Combination With DHAP in Patients With Relapsed or Refractory Hodgkin Lymphoma
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': 'D000068338', 'term': 'Everolimus'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-07', 'studyFirstSubmitDate': '2011-10-17', 'studyFirstSubmitQcDate': '2011-10-17', 'lastUpdatePostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Limiting Toxicity Rate (DLT)', 'timeFrame': '4 weeks', 'description': 'Phase I primary outcome measure'}, {'measure': 'Complete Remission Rate (CR)', 'timeFrame': '4 weeks', 'description': 'Phase II primary outcome measure'}], 'secondaryOutcomes': [{'measure': 'Adverse event rate', 'timeFrame': '4 weeks', 'description': 'Phase I secondary outcome measure'}, {'measure': 'Tumor status (assessed by CT) after chemotherapy', 'timeFrame': '4 weeks', 'description': 'Phase II secondary outcome measure'}, {'measure': 'Tumor status (assessed by PET) after chemotherapy', 'timeFrame': '4 weeks', 'description': 'Phase II secondary outcome measure'}]}, 'conditionsModule': {'conditions': ['Hodgkin Lymphoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ghsg.org', 'label': 'Homepage GHSG'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is\n\n1. to determine the recommended dose of everolimus for a subsequent Phase II trial\n2. to determine the efficacy of everolimus plus DHAP'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* relapsed or refractory Hodgkin Lymphoma\n* age 18-60\n* histology confirmed relapse\n\nExclusion Criteria:\n\n* previous therapy with mTOR inhibitor\n* current CNS involvement\n* other primary malignant disease within the last 3 years'}, 'identificationModule': {'nctId': 'NCT01453504', 'acronym': 'HD-R3i', 'briefTitle': 'Everolimus in Combination With DHAP in Patients With Relapsed or Refractory Hodgkin Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'A Prospective, Randomized, Placebo-controlled, Multicenter, International Phase I/II Trial of RAD001 (Everolimus) in Combination With DHAP as Induction Therapy in Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)', 'orgStudyIdInfo': {'id': 'HD-R3i'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ever-DHAP', 'description': 'Combination of Everolimus and DHAP', 'interventionNames': ['Drug: DHAP', 'Drug: Everolimus']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo-DHAP', 'interventionNames': ['Drug: DHAP']}], 'interventions': [{'name': 'DHAP', 'type': 'DRUG', 'description': 'Dexamethasone, Cytarabine, Cisplatin', 'armGroupLabels': ['Ever-DHAP', 'Placebo-DHAP']}, {'name': 'Everolimus', 'type': 'DRUG', 'armGroupLabels': ['Ever-DHAP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cologne', 'country': 'Germany', 'facility': '1st Dept. of Medicine, Cologne University Hospital', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'overallOfficials': [{'name': 'Peter Borchmann, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Cologne, German Hodgkin Study Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Prof. Dr. Peter Borchmann', 'investigatorAffiliation': 'University of Cologne'}}}}