Lymphoma
Conditions
Keywords
Nodal T Cell Lymphoma, T Follicular Helper, Relapsed/Refractory, Duvelisib, Peripheral T cell lymphoma, Angioimmunoblastic T cell lymphoma, TERZO, 145-304, TFH
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 nodal T cell lymphoma with TFH phenotype.
Interventions
DRUGDuvelisib
oral capsules
DRUGGemcitabine
solution for intravenous infusion
DRUGBendamustine
solution for intravenous infusion
Sponsors
SecuraBio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival (PFS) as assessed by the Independent Review Committee (IRC) | Up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | Up to 3 years |
| PFS as assessed by the investigator | Up to 3 years |
| Objective Response Rate (ORR) as assessed by the IRC | Up to 3 years |
| Complete Response Rate (CRR) as assessed by the IRC | Up to 3 years |
| Duration of Response (DOR) as assessed by the IRC | Up to 3 years |
| Proportion of participants who proceed to Stem Cell Transplantation (SCT) | Up to 3 years |
| Investigator-assessed PFS in participants who proceed to SCT | Up to 3 years |
| Number of participants with Adverse Events (AEs) | Up to 3 years |
| Quality of Life (QoL): European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Score | Up to 3 years |
| QoL: EQ5D Score | Up to 3 years |
| QoL: QLQ-NHL-HG29 Score | Up to 3 years |
| Concentration of Duvelisib and its Metabolites in Blood | Day 1 of Cycle 1 and Cycle 2 (predose and 60 minutes postdose) |
Countries
Belgium, Czechia, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom
Contacts
CONTACTOhad Bentur
Outcome results
None listed