Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-02-03 @ 10:22 PM
Study NCT ID:
NCT00670592
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2008-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of HCD122 in Adults With Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'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': 'C578314', 'term': 'lucatumumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'dispFirstSubmitDate': '2020-08-20', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2008-04-30', 'dispFirstSubmitQcDate': '2020-08-20', 'studyFirstSubmitQcDate': '2008-05-01', 'dispFirstPostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary endpoints (phase I) - Incidence rate of DLT and AE', 'timeFrame': '2 years'}, {'measure': 'Primary endpoint (phase II) - Response rate', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Adverse events by frequency, severity, and duration; pharmacokinetics; immunogenicity; response duration; time to progression', 'timeFrame': '2 years'}]}, 'conditionsModule': {'keywords': ['HCD122', 'CD40', 'NHL', 'HL'], 'conditions': ["Non-Hodgkin's Lymphoma", "Hodgkin's Lymphoma"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=10903', 'label': 'Results for CHCD122A2103 from the Novartis Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': "This study is to evaluate the highest tolerated dose, safety and activity of HCD122 in adults with non-Hodgkin's or Hodgkin's lymphoma who have received at least two prior therapies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nPatients may be included in the study if they meet all of the following criteria:\n\n* Patients must have confirmed diagnosis of HL or NHL (follicular, marginal zone / MALT, diffuse large B-cell, or mantle cell) per REAL/WHO classification\n* Patients must have progressed after at least 2 prior therapies (autologous stem cell transplantation is considered as 1 therapy)\n* Patients must be ≥ 18 years\n* Patients must have life expectancy \\> 3 months\n* Patient must have adequate laboratory results\n* Patients must have WHO Performance Status grade 0, 1, or 2\n* Patients must have at least one site of measurable disease\n* Patients must have discontinued any previous monoclonal antibody or radioimmunotherapy, and must have recovered fully from the side effects of that treatment prior to beginning study treatment.\n* Patients must be willing and able to sign the informed consent form and comply with the study protocol\n\nExclusion criteria:\n\nPatients will be excluded from the study if they meet any of the following criteria:\n\n* Patients who have been treated with any anti-CD40 antibody\n* Patients who have received prior allogeneic stem cell transplant\n* Patients who have had a prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration\n* Patients who have history or clinical evidence of central nervous system, meningeal, or epidural disease including brain metastasis\n* Women of child-bearing potential (WCBP) who are pregnant or breast feeding.\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00670592', 'briefTitle': "Study of HCD122 in Adults With Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies", 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': "A Phase IA/II, Multi-center, Open-label Study of HCD122 Administered Intravenously Once Weekly for Four Weeks in Adult Patients With Advanced Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies (CHIR-12.12-LYM-01)", 'orgStudyIdInfo': {'id': 'CHCD122A2103'}, 'secondaryIdInfos': [{'id': '2007-004888-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'HCD122', 'interventionNames': ['Drug: HCD122']}], 'interventions': [{'name': 'HCD122', 'type': 'DRUG', 'armGroupLabels': ['HCD122']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46107', 'city': 'Beech Grove', 'state': 'Indiana', 'country': 'United States', 'facility': 'St. Francis Cancer Research Foundation Dept.ofSt.FrancisCancerRes.(2)', 'geoPoint': {'lat': 39.72199, 'lon': -86.08998}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer 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