[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100127899":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":19,"locations":19,"responsibleParty":24,"collaborators":19,"id":26,"slug":27,"hasResults":28,"nctId":29,"briefTitle":30,"officialTitle":31,"acronym":19,"eligibilityCriteria":32,"healthyVolunteers":33,"sex":34,"minAge":35,"maxAge":19,"enrollmentInfo":36,"targetDuration":19,"studyType":39,"phases":40,"briefSummary":42,"conditions":43,"keywords":19,"overallStatus":45,"whyStopped":19,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":19},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Arm","EXPERIMENTAL","Patients will first receive an abbreviated course of three cycles of fludarabine (25 mg\u002Fm2 for 5 days every 5 weeks). Iodine I 131 tositumomab will be initiated 6 to 8 weeks after completion of fludarabine. Patients will undergo dosimetry studies to determine the appropriate patient-specific activity of iodine I 131 tositumomab required to deliver a fixed dose of 75 cGy. The dose will be attenuated to 65 cGy for patients with platelet counts between 100,000 and 150,000\u002Fmicoliter.",[13],"Biological: Tositumomab and Iodine I 131 Tositumomab",[15],{"type":16,"name":17,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","Tositumomab and Iodine I 131 Tositumomab",[9],null,[21],{"name":22,"affiliation":5,"role":23},"GSK Clinical Trials","STUDY_DIRECTOR",{"type":25,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100127899","phase-2-study-of-safety-and-efficacy-of-a-sequential-regimen-consisting-of-three-cycles-of-fludarabine-followed-by-tositumomab-and-iodine-i-131-tositumomab-100127899",true,"NCT00933335","Study of Safety and Efficacy of a Sequential Regimen Consisting of Three Cycles of Fludarabine Followed by Tositumomab and Iodine I 131 Tositumomab","Fludarabine Monophosphate Followed by Iodine I 131 Tositumomab for Untreated Low-grade and Follicular Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n* Patients must be age 18 years or older.\n* Patients must have a histologically-confirmed diagnosis of low-grade or follicular non-Hodgkin's B-cell lymphoma.\n* Patients must have Ann Arbor stage III or IV extent of disease after completing staging.\n* Patients must have bi-dimensionally measurable disease. At least one lesion must have both perpendicular diameters \\> 2 cm.\n* Patients must have evidence that their tumor expresses the CD20 antigen by immunohistochemistry or flow cytometry.\n* Patients must have no previous treatment for NHL.\n* Patients must have a Karnofsky performance status of at least 60% and an anticipated survival of at least 3 months.\n* Patients must have absolute granulocyte count greater than or equal to 1500 cells\u002Fmm3 and a platelet count \\> 100,000 cells\u002Fmm3 within 14 days of study entry and not require sustained support with hematopoietic cytokines or transfusion of blood products.\n* Patients must have adequate renal and hepatic function.\n* Patients must sign IRB approved informed consent form(s) prior to study entry.\n\nExclusion Criteria:\n\n* Patients who received systemic steroids within 1 week of study entry, except patients on maintenance steroid therapy for a non-cancerous disease.\n* Patients with evidence of active infection requiring intravenous antibiotics at the time of study entry.\n* Patients with New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation.\n* Patients with known HIV Infection.\n* Patients with known brain or leptomeningeal metastases.\n* Patients who are pregnant or nursing. Patients of childbearing potential must undergo a pregnancy test at screening and on the day fludarabine treatment is started. Treatment is not to be administered until a negative result is obtained. Males and females must agree to use effective contraception for 6 months following the iodine I 131 tositumomab therapy.\n* Patients with prior malignancy other than lymphoma, except for adequately-treated skin cancer in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years.\n* Patients with hypersensitivity to fludarabine.\n* Patients who are receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.\n* Patients who are HAMA positive.\n* Patients with previous allergic reaction to iodine. This does not include reacting to intravenous iodine containing contrast materials.\n\nInclusion Criteria for Iodine I 131 Tositumomab Therapy\n\n* Patients who completed 3 cycles of fludarabine.\n* Patients must have absolute granulocyte count ≥ to 1500\u002Fmm3, platelet count of ≥ 100,000\u002Fmm3 (≥ 150,000\u002Fmm3 if \\> 25% bone marrow involvement at restaging), and not require sustained support with hematopoietic cytokines or transfusions with blood products.\n* Patients must have adequate renal and hepatic function.\n\nExclusion criteria for Antibody Therapy\n\n* Patients with active obstructive hydronephrosis.\n* Patients with evidence of active infection requiring intravenous antibiotics.\n* Patients who are pregnant.",false,"ALL","18 Years",{"count":37,"type":38},38,"ACTUAL","INTERVENTIONAL",[41],"PHASE2","This is a single-arm, single institution, phase II study of fludarabine monophosphate followed by Iodine I 131 Tositumomab for patients with previously untreated, advanced-stage (stage III or IV) low-grade, transformed low-grade and follicular non-Hodgkin's lymphoma. The primary objective of the study will be to evaluate the safety of this treatment combination and the secondary endpoint will be to evaluate efficacy.",[44],"Lymphoma, Non-Hodgkin","COMPLETED","2016-11-30",{"date":48,"type":49},"2017-01-18","ESTIMATED",{"date":51,"type":19},"1998-08",{"date":53,"type":38},"2010-08",{"name":5,"class":6}]