Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-01-09 @ 5:22 PM
Study NCT ID:
NCT00301795
Status:
TERMINATED
Last Update Posted:
2013-01-07
First Post:
2006-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rituximab and Oblimersen in Treating Patients With Stage II, Stage III, or Stage IV Follicular Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'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': 'C408162', 'term': 'oblimersen'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'lastUpdateSubmitDate': '2013-01-04', 'studyFirstSubmitDate': '2006-03-09', 'studyFirstSubmitQcDate': '2006-03-09', 'lastUpdatePostDateStruct': {'date': '2013-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response (OR) rate defined as achievement of a complete (CR) or partial response (PR) as the best observed response', 'timeFrame': '12 months', 'description': "The true OR rate will be estimated using the uniformly minimum unbiased estimator. Jennison and Turnbull's method will be used to obtain 95% exact confidence interval for the true OR rate of each arm reflecting the above two-stage design."}], 'secondaryOutcomes': [{'measure': 'Toxicities assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0', 'timeFrame': 'Up to 10 years', 'description': 'Will be summarized using frequency tables.'}, {'measure': 'Time-to-progression (TTP)', 'timeFrame': 'Up to 10 years', 'description': 'Kaplan-Meier method will be used.'}, {'measure': 'Time-to-best response', 'timeFrame': 'Up to 10 years', 'description': 'Kaplan-Meier method will be used.'}, {'measure': 'Overall survival', 'timeFrame': 'Up to 10 years', 'description': 'Kaplan-Meier method will be used.'}]}, 'conditionsModule': {'conditions': ['Stage III Grade 1 Follicular Lymphoma', 'Stage III Grade 2 Follicular Lymphoma', 'Stage III Grade 3 Follicular Lymphoma', 'Stage IV Grade 1 Follicular Lymphoma', 'Stage IV Grade 2 Follicular Lymphoma', 'Stage IV Grade 3 Follicular Lymphoma']}, 'descriptionModule': {'briefSummary': "Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Oblimersen may help rituximab work better by making cancer cells more sensitive to the drug. This phase II trial is studying how well giving rituximab together with oblimersen works in treating patients with stage II, stage III, or stage IV follicular non-Hodgkin's lymphoma", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the response rate (overall and complete response rate) after rituximab + oblimersen sodium extended induction therapy in previously untreated cluster of differentiation 20 positive (CD20+) follicular non-Hodgkin lymphoma (NHL) patients.\n\nII. To determine the time to progression after rituximab + oblimersen sodium extended induction therapy in previously untreated CD20+ follicular NHL patients.\n\nSECONDARY OBJECTIVES:\n\nI. To determine the toxicity profile of rituximab + oblimersen sodium therapy in previously untreated CD20+ follicular NHL patients.\n\nII. To establish whether the therapeutic effects of the rituximab + oblimersen sodium combination are sufficiently promising to warrant evaluation in a subsequent randomized trial (in comparison to rituximab alone).\n\nIII. To correlate Fc receptor profiling to response to rituximab + oblimersen sodium in previously untreated patients with follicular NHL.\n\nIV. To determine the relationship between change in fludeoxyglucose F 18 (FDG) uptake early after treatment with rituximab + oblimersen sodium to response rate and time to progression.\n\nOUTLINE: This is a multicenter study.\n\nInduction therapy (month 1): Patients receive oblimersen IV continuously on days 1-7 and 15-21 and rituximab IV on days 3, 10, 17, and 24 in month 1.\n\nExtended induction therapy (months 3, 5, 7, and 9): Patients receive oblimersen IV continuously on days 22-28 and rituximab IV on day 24 in months 3, 5, 7, and 9.\n\nTreatment continues for 9 months in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed periodically for up to 10 years.\n\nPROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previously untreated, histologically confirmed follicular lymphoma, WHO classification, grade 1, 2, or 3a (\\> 15 centroblasts per high power field with centrocytes present) which is stage III, IV, or bulky (i.e., single mass \\>= 7 cm in any unidimensional measurement) stage II\n* Institutional flow cytometry or immunohistochemistry must confirm CD20 antigen expression\n* Patients classified as high risk according to the Follicular Lymphoma International Prognostic Index (FLIPI) should be considered for CALGB 50102/SWOG S0016\n* No prior therapy for non-Hodgkin lymphoma including chemotherapy, radiation or immunotherapy (e.g., monoclonal antibody-based therapy)\n* No corticosteroids within two weeks prior to study, except for maintenance therapy for a non-malignant disease\n* ECOG performance status 0-2\n* Measurable disease must be present either on physical examination or imaging studies; non-measurable disease alone is not acceptable; any tumor mass \\> 1 cm is acceptable; lesions that are considered non-measurable include the following:\n\n * Bone lesions (lesions if present should be noted)\n * Ascites\n * Pleural/pericardial effusion\n * Lymphangitis cutis/pulmonis\n * Bone marrow (involvement by non-Hodgkin lymphoma should be noted)\n* No known CNS involvement by lymphoma\n* No known HIV infection\n* Non-pregnant and non-nursing; women and men of reproductive potential should agree to use an effective means of birth control throughout their participation in this study; appropriate methods of birth control include oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom)\n* Patients with a "currently active" second malignancy, other than nonmelanoma skin cancers are not eligible; (this includes Waldenstrom\'s Macroglobulinemia, since such patents have experienced transient increases in IgM following initiation of rituximab, with the potential for hyperviscosity syndrome requiring plasmapheresis); patients are not considered to have a "currently active" malignancy if they have completed anti-cancer therapy, and are considered by their physician to be at less than 30% risk of relapse\n* ANC \\>= 1000/uL\n* Platelet count \\>= 50,000/uL\n* Creatinine =\\< 2 x ULN\n* Total bilirubin =\\< 2 x ULN; unless attributable to Gilbert\'s disease'}, 'identificationModule': {'nctId': 'NCT00301795', 'briefTitle': "Rituximab and Oblimersen in Treating Patients With Stage II, Stage III, or Stage IV Follicular Non-Hodgkin's Lymphoma", 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase II Trial of Rituximab + Oblimersen Sodium (GenasenseTM, G3139, NSC #683428, IND #58842) in Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma (NHL)', 'orgStudyIdInfo': {'id': 'NCI-2012-03080'}, 'secondaryIdInfos': [{'id': 'CALGB 50404'}, {'id': 'U10CA031946', 'link': 'https://reporter.nih.gov/quickSearch/U10CA031946', 'type': 'NIH'}, {'id': 'CDR0000462385', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (oblimersen sodium and rituximab)', 'description': 'Induction therapy (month 1): Patients receive oblimersen IV continuously on days 1-7 and 15-21 and rituximab IV on days 3, 10, 17, and 24 in month 1.\n\nExtended induction therapy (months 3, 5, 7, and 9): Patients receive oblimersen IV continuously on days 22-28 and rituximab IV on day 24 in months 3, 5, 7, and 9.\n\nTreatment continues for 9 months in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Biological: oblimersen sodium', 'Biological: rituximab', 'Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'oblimersen sodium', 'type': 'BIOLOGICAL', 'otherNames': ['augmerosen', 'G3139', 'G3139 bcl-2 antisense oligodeoxynucleotide', 'Genasense'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (oblimersen sodium and rituximab)']}, {'name': 'rituximab', 'type': 'BIOLOGICAL', 'otherNames': ['IDEC-C2B8', 'IDEC-C2B8 monoclonal antibody', 'Mabthera', 'MOAB IDEC-C2B8', 'Rituxan'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (oblimersen sodium and rituximab)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (oblimersen sodium and rituximab)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60606', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cancer and Leukemia Group B', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Barbara Grant', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer and Leukemia Group B'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}