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/refractory nodal T cell lymphoma with TFH phenotype.
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.
Relapsed or refractory to at least 1 prior systemic, cytotoxic therapy for T cell lymphoma.
Measurable disease as defined by Lugano 2014 criteria (Cheson 2014) for T cell lymphoma.
Cutaneous-only disease.
Received prior allogeneic transplant any time in the past or received autologous transplant within 60 days prior to the first dose of study drug.
Received prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor.
Prior exposure to planned study treatment investigator's choice therapy (gemcitabine or bendamustine) within 60 days prior to the first dose of study drug.
Parallel
Duvelisib
Drugoral capsules
Gemcitabine
Drugsolution for intravenous infusion
Bendamustine
Drugsolution for intravenous infusion
Progression-free Survival (PFS) as assessed by the Independent Review Committee (IRC)
Overall Survival (OS)
PFS as assessed by the investigator
Objective Response Rate (ORR) as assessed by the IRC
Complete Response Rate (CRR) as assessed by the IRC
