Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2025-12-29 @ 1:06 PM
Study NCT ID:
NCT00575068
Status:
COMPLETED
Last Update Posted:
2012-06-08
First Post:
2007-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of IDEC-114 in the Treatment of Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], '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': 'C437823', 'term': 'galiximab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-07', 'studyFirstSubmitDate': '2007-12-13', 'studyFirstSubmitQcDate': '2007-12-13', 'lastUpdatePostDateStruct': {'date': '2012-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To characterize the safety profile of IDEC-114 and to define their duration and reversibility', 'timeFrame': 'March 2010'}], 'secondaryOutcomes': [{'measure': 'To evaluate PK', 'timeFrame': 'March 2010'}, {'measure': 'To monitor presence of human anti galiximab antibody', 'timeFrame': 'March 2010'}, {'measure': 'To evaluate efficacy', 'timeFrame': 'March 2010'}, {'measure': 'To identify Nk functional assays that may predict galiximab efficacy', 'timeFrame': 'March 2010'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Non-Hodgkin's Lymphoma"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether anti-CD80 monoclonal antibody (IDEC-114) is effective in the treatment of follicular B-cell non-Hodgkin's lymphoma. This drug has never been studied in patients with lymphoma, however, it has been studied in psoriasis patients at various dose levels and schedules."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed follicular lymphoma that has relapsed or has failed primary therapy\n* Progressive disease requiring further treatment\n* Bidimensionally measurable disease\n* Acceptable hematologic status\n* Prestudy WHO performance status of 0, 1, or 2\n* Expected survival of \\>/= 3 months\n* Patients with reproductive potential must follow accepted birth control methods during treatment and for 3 months after completion of treatment\n* Female patients must not be pregnant or lactating\n* Recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, ABMT, or investigational drugs\n\nExclusion Criteria:\n\n* Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks of first scheduled treatment (6 weeks if nitrosourea or mitomycin-C)\n* Prednisone or other immunosuppressive therapy within 3 weeks of first scheduled treatment\n* Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to first scheduled treatment\n* Previous exposure to IDEC-114 or any anti-CD80 antibody\n* ABMT within 6 months prior to first scheduled treatment\n* Abnormal liver function\n* Abnormal renal function\n* Presence of chronic lymphocytic leukemia (CLL)\n* Presence of CNS lymphoma\n* Presence of HIV infection or AIDS\n* Prior diagnosis of aggressive non-Hodgkin's lymphoma or mantle-cell lymphoma\n* Another primary malignancy (other than squamous cell and basal cell carcinoma of the skin, in situ carcinoma of the cervix, or treated prostate cancer with a stable PSA) for which the patient has not been disease-free for at least 3 years\n* Serious nonmalignant disease which would compromise protocol objectives in the opinion of the investigator and/or the sponsor\n* New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to first scheduled treatment\n* Major surgery, other than diagnostic surgery, within 4 weeks prior to first scheduled treatment\n* Pleural invasion and/or effusion with positive cytology for lymphoma\n* Peritoneal invasion and/or ascites with positive cytology for lymphoma"}, 'identificationModule': {'nctId': 'NCT00575068', 'briefTitle': "Safety and Efficacy of IDEC-114 in the Treatment of Non-Hodgkin's Lymphoma", 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Phase I/II Trial of Anti-CD80 Monoclonal Antibody (IDEC-114) Therapy for Patients With Relapsed or Refractory Follicular Lymphoma', 'orgStudyIdInfo': {'id': '114-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: IDEC-114']}], 'interventions': [{'name': 'IDEC-114', 'type': 'DRUG', 'description': 'Phase 1-A Group 1 - 125 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase 1-A Group 2 - 250 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase 1-A Group 3 - 375 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase 1-B Group 4 - 500 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase II-A \\& II-B - Dosage start at the MTD (up to 375 mg/m2)', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '55902', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Biogen Idec MD', 'oldOrganization': 'Biogen Idec'}}}}