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1PB",{"type":49,"coordinates":649},[650,651],-1.15047,52.9536,{"lat":651,"lon":650},[654,656],{"name":26,"role":37,"phone":26,"phoneExt":26,"email":655},"christopher.fox@nhs.net",{"name":657,"role":59,"phone":26,"phoneExt":26,"email":26},"Christopher Fox",{"facility":659,"status":43,"city":660,"state":26,"zip":661,"country":575,"countryCode":576,"cosmosGeoPoint":662,"geoPoint":666,"contacts":667},"Oxford University Hospitals NHS Foundation Trust","Oxford","OX3 7LE",{"type":49,"coordinates":663},[664,665],-1.25596,51.75222,{"lat":665,"lon":664},[668,670],{"name":26,"role":37,"phone":26,"phoneExt":26,"email":669},"graham.collins@ouh.nhs.uk",{"name":671,"role":59,"phone":26,"phoneExt":26,"email":26},"Graham Collins",{"type":673,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","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",false,"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.","ALL","18 Years",{"count":685,"type":686},124,"ESTIMATED","INTERVENTIONAL",[689],"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.",[692],"Lymphoma",[694,695,696,9,697,698,680,699,700],"Nodal T Cell Lymphoma","T Follicular Helper","Relapsed\u002FRefractory","Peripheral T cell lymphoma","Angioimmunoblastic T cell lymphoma","145-304","TFH","2026-04-03",{"date":703,"type":704},"2026-04-06","ACTUAL",{"date":706,"type":704},"2025-05-19",{"date":708,"type":686},"2028-12",{"name":5,"class":6},44]