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Trial Title:
A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype
NCT ID:
NCT06522737
Condition:
Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Gemcitabine
Bendamustine Hydrochloride
Conditions: Keywords:
Nodal T Cell Lymphoma
T Follicular Helper
Relapsed/Refractory
Duvelisib
Peripheral T cell lymphoma
Angioimmunoblastic T cell lymphoma
TERZO
145-304
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Duvelisib
Description:
oral capsules
Arm group label:
Duvelisib
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
solution for intravenous infusion
Arm group label:
Gemcitabine or Bendamustine
Intervention type:
Drug
Intervention name:
Bendamustine
Description:
solution for intravenous infusion
Arm group label:
Gemcitabine or Bendamustine
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
December 2024
Completion date:
December 2028
Lead sponsor:
Agency:
SecuraBio
Agency class:
Industry
Source:
SecuraBio
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06522737
