[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"SecuraBio\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":78},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100647862","phase-1-a-study-of-topical-duvelisib-in-participants-with-early-stage-mycosis-fungoides-100647862",false,"NCT07714187","A Study of Topical Duvelisib in Participants With Early-stage Mycosis Fungoides","A Phase 1 Dose-escalation Study of Topical Duvelisib in Patients With Early-stage Mycosis Fungoides","Key Inclusion Criteria:\n\n* Have a clinical diagnosis of Stage IA, Stage IB, or Stage IIA mycosis fungoides (cutaneous T-cell lymphoma), without clinically significant lymphadenopathy (≥1.5 centimeters).\n* Have 3 to 5 active, treatment-accessible mycosis fungoides lesions; ulcerated lesions and lesions to the face, neck, inguinal folds and intergluteal cleft are not considered suitable for administration of study drug.\n* Have baseline organ function (without transfusion support within 30 days of Cycle 1 Day 1) as defined by the protocol.\n\nKey Exclusion Criteria:\n\n* Have Stage IIB to IVB mycosis fungoides or Sezary syndrome.\n* Have histopathologically confirmed lymph node involvement.\n* Received systemic treatment with a phosphoinositide 3-kinases inhibitor in the 60 days prior to starting study drug.\n* Received topical steroids or other topical treatment (for example, nitrogen mustard) on mycosis fungoides lesions in the 2 weeks prior to starting study drug. Participants who receive such agents may become eligible for the study after a 14-day washout period.\n* Received systemic steroids, immunosuppressants (for example, cyclosporine, prednisone), psoralen ultraviolet A radiation therapy, narrow-band ultraviolet B light therapy, carmustine or other systemic therapies for mycosis fungoides in the 3 weeks prior to starting study drug.\n* Received electron beam irradiation within the 3 months prior to starting study drug.\n\nNote: other protocol-defined criteria apply.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This study will evaluate the safety and preliminary efficacy of duvelisib topical gel in participants with early-stage mycosis fungoides.",[26,27],"Mycosis Fungoides","Cutaneous T-cell Lymphoma",[29,30,31],"Early-stage mycosis fungoides","Duvelisib","Topical","NOT_YET_RECRUITING","2026-07-15",{"date":35,"type":36},"2026-07-20","ACTUAL",{"date":38,"type":20},"2027-01",{"date":40,"type":20},"2029-01",{"name":42,"class":43},"SecuraBio","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100556256","phase-3-a-study-of-duvelisib-versus-gemcitabine-or-bendamustine-in-participants-with-relapsedrefractory-nodal-t-cell-lymphoma-with-t-follicular-helper-tfh-phenotype-100556256","NCT06522737","A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed\u002FRefractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype","A Multicentre, Open-label, Phase 3, Randomised Controlled Trial of Duvelisib Versus Investigator's Choice of Gemcitabine or Bendamustine in Patients With Relapsed\u002FRefractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype","TERZO","Key Inclusion Criteria:\n\n* Pathologically confirmed nodal T cell lymphoma with TFH phenotype according to the criteria of the World Health Organization classification (Swerdlow 2017, Alaggio 2022) including any one of Angioimmunoblastic T cell lymphoma (AITL), follicular T cell lymphoma, and other nodal peripheral T cell lymphoma (PTCL) with a TFH phenotype.\n* Relapsed or refractory to at least 1 prior systemic, cytotoxic therapy for T cell lymphoma.\n* Measurable disease as defined by Lugano 2014 criteria (Cheson 2014) for T cell lymphoma.\n\nKey Exclusion Criteria:\n\n* Cutaneous-only disease.\n* Received prior allogeneic transplant any time in the past or received autologous transplant within 60 days prior to the first dose of study drug.\n* Received prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor.\n* Prior exposure to planned study treatment investigator's choice therapy (gemcitabine or bendamustine) within 60 days prior to the first dose of study drug.\n\nOther protocol-defined criteria apply.",{"count":54,"type":20},124,[56],"PHASE3","The study will evaluate the progression-free survival benefit of duvelisib monotherapy as compared to investigator's choice of gemcitabine or bendamustine in participants with relapsed\u002Frefractory nodal T cell lymphoma with TFH phenotype.",[59],"Lymphoma",[61,62,63,30,64,65,51,66,67],"Nodal T Cell Lymphoma","T Follicular Helper","Relapsed\u002FRefractory","Peripheral T cell lymphoma","Angioimmunoblastic T cell lymphoma","145-304","TFH","RECRUITING","2026-04-03",{"date":71,"type":36},"2026-04-06",{"date":73,"type":36},"2025-05-19",{"date":75,"type":20},"2028-12",{"name":42,"class":43},44,""]