A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype (TERZO)
Status and phase
Enrolling
Phase 3
Conditions
Lymphoma
Treatments
Drug: Duvelisib
Drug: Bendamustine
Drug: Gemcitabine
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
124 estimated patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion criteria
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-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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
124 participants in 2 patient groups
Duvelisib
Experimental group
Description:
Duvelisib will be administered orally twice daily (BID) in 28-day cycles.
Treatment:
Drug: Duvelisib
Gemcitabine or Bendamustine
Active Comparator group
Description:
Participants will receive the investigator's choice of gemcitabine or bendamustine. The regimen to be used after randomization must be selected by the investigator prior to randomization. Gemcitabine will be administered intravenously (IV) on days 1, 8, and 15 of each 28-day cycle for up to 6 cycles. Bendamustine will be administered IV on days 1 and 2 of each 21-day cycle for up to 6 cycles.
Treatment:
Drug: Gemcitabine
Drug: Bendamustine
Trial contacts and locations
15
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Central trial contact
Ohad Bentur
Data sourced from clinicaltrials.gov
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