Status:
RECRUITING
A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype
Lead Sponsor:
SecuraBio
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 noda...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
May 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT06522737
Start Date
May 19 2025
End Date
December 1 2028
Last Update
December 12 2025
Active Locations (43)
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1
Universitair Ziekenhuis Gent (UZ Gent)
Ghent, Belgium, 9000
2
UZ Leuven - Gasthuisberg Campus
Leuven, Belgium, 3000
3
Vseobecna fakultni nemocnice
Prague, Czechia, 128 08
4
Aarhus University Hospital
Aarhus, Denmark, DK-8200