RecruitingPhase 3NCT06522737
A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory 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/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype
Sponsor
SecuraBio
Enrollment
124 participants
Start Date
May 19, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- 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.
Exclusion Criteria5
- 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.
- Other protocol-defined criteria apply.
Interventions
DRUGDuvelisib
oral capsules
DRUGGemcitabine
solution for intravenous infusion
DRUGBendamustine
solution for intravenous infusion
Locations(43)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06522737
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