Clinical trial NCT06522737: A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Lymphoma
Keywords: Nodal T Cell Lymphoma
T Follicular Helper
Relapsed/Refractory
Duvelisib
Peripheral T cell lymphoma
Angioimmunoblastic T cell lymphoma
TERZO
145-304
Lead sponsor: SecuraBio
Sponsor class: INDUSTRY
First posted: 2024-07-26
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Progression-free Survival (PFS) as assessed by the Independent Review Committee (IRC)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 3 years
measure: PFS as assessed by the investigator
timeFrame: Up to 3 years
measure: Objective Response Rate (ORR) as assessed by the IRC
timeFrame: Up to 3 years
measure: Complete Response Rate (CRR) as assessed by the IRC
timeFrame: Up to 3 years
measure: Duration of Response (DOR) as assessed by the IRC
timeFrame: Up to 3 years
measure: Proportion of participants who proceed to Stem Cell Transplantation (SCT)
timeFrame: Up to 3 years
measure: Investigator-assessed PFS in participants who proceed to SCT
timeFrame: Up to 3 years
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to 3 years
measure: Quality of Life (QoL): European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Score
timeFrame: Up to 3 years
measure: QoL: EQ5D Score
timeFrame: Up to 3 years
measure: QoL: QLQ-NHL-HG29 Score
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
References: