[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100330869":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":35,"centralContacts":39,"locations":47,"responsibleParty":145,"collaborators":147,"id":151,"slug":152,"hasResults":153,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":28,"eligibilityCriteria":157,"healthyVolunteers":153,"sex":158,"minAge":159,"maxAge":28,"enrollmentInfo":160,"targetDuration":28,"studyType":163,"phases":164,"briefSummary":166,"conditions":167,"keywords":171,"overallStatus":50,"whyStopped":28,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":183},{"fullName":5,"class":6},"Memorial Sloan Kettering Cancer Center","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"not been previously treated with brentuximab vedotin.","EXPERIMENTAL","Patients with MF\u002FSS who have not been previously treated with brentuximab vedotin. For MF patients: Treatment delays lasting longer than 8 weeks for toxicity will result in removal from study. As of October 2020, the Simon two stage design for Cohort 1 has restarted at the 1.2 mg\u002Fkg dose.",[13],"Drug: brentuximab vedotin",{"label":15,"type":10,"description":16,"interventionNames":17},"treated with reduced dose brentuximab vedotin","Patients with MF\u002FSS who were previously treated with brentuximab vedotin. Up to 10 patients will be enrolled onto this cohort. Following identification of a promising dose after the completion of the full Cohort 1 Simon two stage design, enrollment will initiate onto cohort 2 at the dose found to be promising in cohort 1. For MF patients: Treatment delays lasting longer than 8 weeks for toxicity will result in removal from study. The 0.9mg\u002Fkg dose did not meet the primary endpoint for response, therefore 1.2 mg\u002Fkg has been chosen as the dose for Cohort 2. As of October 2020, enrollment on our exploratory Cohort 2 has opened at the 1.2 mg\u002Fkg dose.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Patients with LyP","Patients with LyP patients with lymphomatoid papulosis will receive brentuximab vedotin 0.9 mg\u002Fkg as an intravenous infusion over 30 minutes every three weeks. Cohort 3 will enroll patients concurrently with Cohort 1. Treatment may be held if felt to be in patient's best interest (for example: for toxicity or no active disease). Treatment can be reinitiated after discussion with MSK PI as long as the study is still open and patient has not received alternate systemic therapy.",[13],[23,29,32],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","brentuximab vedotin","MF\u002FSS Brentuximab vedotin 0.9 mg\u002Fkg 0R 1.2 mg\u002Fkg.",[9],null,{"type":24,"name":25,"description":30,"armGroupLabels":31,"otherNames":28},"LyP Brentuximab vedotin 0.9 mg\u002Fkg2",[19],{"type":24,"name":25,"description":33,"armGroupLabels":34,"otherNames":28},"MF\u002FSS prior brentuximab vedotin-Brentuximab vedotin dose to be determined from Cohort 1",[15],[36],{"name":37,"affiliation":5,"role":38},"Alison Moskowitz, MD","PRINCIPAL_INVESTIGATOR",[40,44],{"name":37,"role":41,"phone":42,"phoneExt":28,"email":43},"CONTACT","646-608-3726","moskowia@mskcc.org",{"name":45,"role":41,"phone":46,"phoneExt":28,"email":28},"Patricia Myskowski, MD","646-608-2351",[48,66,78,89,100,112,123,134],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Stanford University Medical Center","RECRUITING","Stanford","California","94305-5408","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-122.16608,37.42411,{"lat":60,"lon":59},[63],{"name":64,"role":41,"phone":65,"phoneExt":28,"email":28},"Youn Kim, MD","(650) 498-6000",{"facility":67,"status":50,"city":68,"state":69,"zip":70,"country":54,"countryCode":55,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Memorial Sloan Kettering Basking Ridge","Basking Ridge","New Jersey","07920",{"type":57,"coordinates":72},[73,74],-74.54932,40.70621,{"lat":74,"lon":73},[77],{"name":37,"role":41,"phone":42,"phoneExt":28,"email":28},{"facility":79,"status":50,"city":80,"state":69,"zip":81,"country":54,"countryCode":55,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Memorial Sloan Kettering Monmouth","Middletown","07748",{"type":57,"coordinates":83},[84,85],-74.11709,40.39428,{"lat":85,"lon":84},[88],{"name":37,"role":41,"phone":42,"phoneExt":28,"email":28},{"facility":90,"status":50,"city":91,"state":69,"zip":92,"country":54,"countryCode":55,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Memorial Sloan Kettering Bergen","Montvale","07645",{"type":57,"coordinates":94},[95,96],-74.02292,41.04676,{"lat":96,"lon":95},[99],{"name":37,"role":41,"phone":42,"phoneExt":28,"email":28},{"facility":101,"status":50,"city":102,"state":103,"zip":104,"country":54,"countryCode":55,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Memorial Sloan Kettering Commack","Commack","New York","11725",{"type":57,"coordinates":106},[107,108],-73.29289,40.84288,{"lat":108,"lon":107},[111],{"name":37,"role":41,"phone":42,"phoneExt":28,"email":28},{"facility":113,"status":50,"city":114,"state":103,"zip":115,"country":54,"countryCode":55,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Memorial Sloan Kettering Westchester","East White Plains","10604",{"type":57,"coordinates":117},[118,119],-73.74763,41.03899,{"lat":119,"lon":118},[122],{"name":37,"role":41,"phone":42,"phoneExt":28,"email":28},{"facility":5,"status":50,"city":103,"state":103,"zip":124,"country":54,"countryCode":55,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"10065",{"type":57,"coordinates":126},[127,128],-74.00597,40.71427,{"lat":128,"lon":127},[131,132,133],{"name":37,"role":41,"phone":42,"phoneExt":28,"email":28},{"name":45,"role":41,"phone":46,"phoneExt":28,"email":28},{"name":37,"role":38,"phone":28,"phoneExt":28,"email":28},{"facility":135,"status":50,"city":136,"state":103,"zip":137,"country":54,"countryCode":55,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Memorial Sloan Kettering Nassau","Uniondale","11553",{"type":57,"coordinates":139},[140,141],-73.59291,40.70038,{"lat":141,"lon":140},[144],{"name":37,"role":41,"phone":42,"phoneExt":28,"email":28},{"type":146,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[148],{"name":149,"class":150},"Seagen Inc.","INDUSTRY","100330869","phase-2-dosing-of-brentuximab-vedotin-for-mycosis-fungoides-sezary-syndrome-patients-100330869",false,"NCT03587844","Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients","Optimizing Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome, and Lymphomatoid Papulosis","Inclusion Criteria:\n\nMycosis fungoides (MF) and Sezary Syndrome (SS)\n\n1. Pathologically confirmed mycosis fungoides\u002Fsezary syndrome at the enrolling institution, disease stage IB (defined as patches, plaque, or papules that involve 10% of the skin surface viscera) or higher\n\n   ° CD30 negative mycosis fungoides patients are eligible.\n2. Age ≥ 18 years\n3. ECOG Performance Score ≤ 2\n4. For Cohort 1, patients who have not received brentuximab vedotin are eligible.\n5. For Cohort 2, patients who have previously had brentuximab vedotin for MF\u002FSS are eligible. Patients previously treated on Cohort 1 who were discontinued due to toxicity are not eligible for Cohort 2.\n6. Previous systemic anti-cancer therapy must have been discontinued at least 2 weeks prior to treatment.\n\n   ° See section 6.2 Subject Exclusion Criteria for guidelines regarding adjuvant and maintenance therapy for prior malignancy.\n7. Topical or systemic steroids (equivalent to ≤ 10 mg\u002Fday of prednisone) may be considered if dose has been constant and discontinuation may lead to rebound flare in disease, adrenal insufficiency, and\u002For unnecessary suffering, after discussion with PI.\n8. If HIV+, patient must be on stable anti-retroviral treatment for 12 weeks prior to C1D1, with CD4 count \\>200 within 7 days prior to C1D1.\n9. Females of childbearing potential must be on acceptable form of birth control per instutional standard.\n\nLymphomatoid papulosis (LyP)\n\n1. Pathologically confirmed lymphomatoid papulosis at the enrolling institution\n2. Requiring systemic treatment per investigator's discretion\n3. Age ≥ 18 years\n4. ECOG Performance Score ≤ 2\n5. Previous systemic anti-cancer therapy must have been discontinued at least 2 weeks prior to treatment.\n6. Topical or systemic steroids (equivalent to ≤ 10 mg\u002Fday of prednisone) may be considered if dose has been constant and discontinuation may lead to rebound flare in disease, adrenal insufficiency, and\u002For unnecessary suffering.\n7. If HIV+, patient must be on stable anti-retroviral treatment for 12 weeks prior to C1D1, with CD4 count \\>200 within 7 days prior to C1D1.\n8. Females of childbearing potential must be on acceptable form of birth control per institutional standard\n\nExclusion Criteria:\n\n1. Concurrent use of other systemic anti-cancer agents or treatments for mycosis fungoides\u002Fsezary syndrome, or lymphomatoid papulosis.\n2. Grade 2 or greater neuropathy\n3. Severe renal impairment (CrCL \\\u003C30 mL\u002Fmin)\n4. Moderate or severe hepatic impairment (Child-Pugh B or Child-Pugh C)\n\n   ° See Appendix E for Child Pugh Classification chart\n5. Women of reproductive potential† must have a negative Serum ß human chorionic gonadotropin (ß-HCG) pregnancy test within 1 week of C1D1. They should discuss contraception with treating provider.\n6. Previous use of brentuximab vedotin (for Cohort 1 ONLY)\n7. Receiving systemic therapy for another primary malignancy (other than T-cell lymphoma).\n\n   * Patients with more than one type of lymphoma may be enrolled after discussion with the MSK Principal Investigator.\n   * Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy (other than T-cell lymphoma) is permissible after discussion with the MSK Principal Investigator.\n8. For Cohort 2, patients who previously progressed on the standard 1.8mg\u002Fkg dose and schedule of brentuximab vedotin are ineligible.\n\n   * A female of reproductive potential is a sexually mature female who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had menses at any time in the preceding 24 consecutive months).","ALL","18 Years",{"count":161,"type":162},58,"ESTIMATED","INTERVENTIONAL",[165],"PHASE2","The purpose of this study is to test any good and bad effects of the study drug called brentuximab vedotin at a lower dose than is FDA-approved.",[168,169,170],"Mycosis Fungoides","Lymphomatoid Papulosis","Sezary Syndrome",[172,173],"Brentuximab Vedotin","18-147","2026-04-02",{"date":176,"type":177},"2026-04-03","ACTUAL",{"date":179,"type":177},"2018-07-03",{"date":181,"type":162},"2027-07",{"name":5,"class":6},8]