Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-29 @ 12:25 PM
Study NCT ID:
NCT00384150
Status:
TERMINATED
Last Update Posted:
2015-11-26
First Post:
2006-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retreatment Study of Galiximab + Rituximab in Follicular Non-Hodgkin's Lymphoma (NHL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Austria', 'Belarus', 'Canada', 'Croatia', 'Czechia', 'France', 'Germany', 'Israel', 'Italy', 'Latvia', 'Lithuania', 'Moldova', 'New Zealand', 'Norway', 'Poland', 'Puerto Rico', 'Romania', 'Russia', 'Slovakia', 'Spain', 'Sweden', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D012008', 'term': 'Recurrence'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C437823', 'term': 'galiximab'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'Enrollment challenges due to changes in standards of care resulted in premature termination. No safety or efficacy events factored into this action.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'dispFirstSubmitDate': '2015-10-30', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-30', 'studyFirstSubmitDate': '2006-10-04', 'dispFirstSubmitQcDate': '2015-10-30', 'studyFirstSubmitQcDate': '2006-10-04', 'dispFirstPostDateStruct': {'date': '2015-11-26', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety measures include: adverse event rates, clinical laboratory results, development of anti-galiximab and human anti-chimeric antibodies', 'timeFrame': 'Study period is approx. 2 years'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics', 'timeFrame': 'Study period is approx. 2 years'}, {'measure': 'To further characterize the efficacy profile of galiximab in combination with rituximab', 'timeFrame': 'Study period is approx. 2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['galiximab', 'antibody', 'refractory', 'follicular', 'relapsed', 'NHL', 'rituximab', 'retreatment'], 'conditions': ["Lymphoma, Non-Hodgkin's"]}, 'descriptionModule': {'briefSummary': 'This is a Phase III, multicenter, global, open-label, single-arm, retreatment study of an investigational drug called galiximab in combination with an approved drug called rituximab in subjects with relapsed or refractory, follicular NHL who demonstrated a response on Study 114-NH-301 with a time-to-progression \\>=6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Demonstrated a response (CR, CRu, or PR) on Study 114-NH-301 (Galiximab in combination with Rituximab compared with Rituximab in combination with Placebo) and then relapsed or progressed with a TTP \\>=6 months. Relapsed disease is defined as documented disease progression using the International Workshop Response Criteria (IWRC).\n* Bidimensionally measurable disease with at least 1 lesion \\>=2.0 cm in a single dimension.\n* Acceptable hematologic, hepatic, and renal function.\n\nKey Exclusion Criteria:\n\n* Any lymphoma therapy between Final Visit on Study 114-NH-301 and Study Day 1 of this retreatment study.\n* Chronic or intermittent corticosteroids for inflammatory or autoimmune disorders within 3 weeks prior to Study Day 1.\n* Transfusion-dependent subjects.\n* Presence of central nervous system (CNS) lymphoma.\n* Histologic transformation.\n* Presence of pleural or peritoneal effusion with positive cytology for lymphoma.\n* Another primary malignancy requiring active treatment.\n* Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions that 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 Study Day 1.'}, 'identificationModule': {'nctId': 'NCT00384150', 'briefTitle': "Retreatment Study of Galiximab + Rituximab in Follicular Non-Hodgkin's Lymphoma (NHL)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': "A Phase III, Open-Label, Multicenter, Single-Arm, Retreatment Study of Galiximab in Combination With Rituximab for Subjects With Relapsed, Follicular Non-Hodgkin's Lymphoma Who Previously Responded on Study 114-NH-301", 'orgStudyIdInfo': {'id': '114-NH-302'}}, 'armsInterventionsModule': {'interventions': [{'name': 'galiximab in combination with rituximab', 'type': 'DRUG', 'description': 'galiximab (500 mg/m2 IV) in combination with rituximab (375 mg/m2 IV)once weekly for 4 weeks.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biogen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}