A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refr
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.
| Condition(s) | Lymphoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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-kina |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | SecuraBio |
| Locations | Ghent, Belgium; Leuven, Belgium; Prague, Czechia; Aarhus, Denmark; Copenhagen, Denmark; Odense, Denmark (+38 more sites) |
| Start date | 2025-05-19 |
| NCT ID | NCT06522737 |
| Official listing | https://clinicaltrials.gov/study/NCT06522737 |