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 (TERZO)

Conditions

relapsed/refractory nodal T cell lymphoma with T follicular helper (TFH) phenotype

Brief summary

Progression-free Survival (PFS) according to the Lugano 2014 criteria (Cheson 2014) as assessed by the Independent Review Committee (IRC) or death due to any cause - Up to 3 years

Detailed description

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, Incidence/frequency of Adverse Events (AEs) and abnormal laboratory values - 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

Kate Cwynarski, Eva Domingo‐Doménech, David Sidransky, Ohad S. Bentur, Pier Luigi Zinzani

Blood2024-11-05

10.1182/blood-2024-203290

Interventions

DRUGDUVELISIB

DRUGBENDAMUSTINE

DRUGCopiktra 15 mg hard capsules

DRUGCopiktra 25 mg hard capsules

DRUGGEMCITABINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free Survival (PFS) according to the Lugano 2014 criteria (Cheson 2014) as assessed by the Independent Review Committee (IRC) or death due to any cause - 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, Incidence/frequency of Adverse Events (AEs) and abnormal laboratory values - 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	—

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, Incidence/frequency of Adverse Events (AEs) and abnormal laboratory values - 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

—

Countries

Belgium, Czechia, Denmark, France, Germany, Italy, Netherlands, Poland, Spain

Outcome results

None listed