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

Overview

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

• Drug Duvelisib
  oral capsules
• Drug Gemcitabine
  solution for intravenous infusion
• Drug Bendamustine
  solution for intravenous infusion

Primary outcome measures

• Progression-free Survival (PFS) as assessed by the Independent Review Committee (IRC) [Time frame: Up to 3 years]

Secondary outcome measures (12)

• Overall Survival (OS) [Time frame: Up to 3 years]
• PFS as assessed by the investigator [Time frame: Up to 3 years]
• Objective Response Rate (ORR) as assessed by the IRC [Time frame: Up to 3 years]
• Complete Response Rate (CRR) as assessed by the IRC [Time frame: Up to 3 years]
• Duration of Response (DOR) as assessed by the IRC [Time frame: Up to 3 years]
• Proportion of participants who proceed to Stem Cell Transplantation (SCT) [Time frame: Up to 3 years]
• Investigator-assessed PFS in participants who proceed to SCT [Time frame: Up to 3 years]
• Number of participants with Adverse Events (AEs) [Time frame: Up to 3 years]
• Quality of Life (QoL): European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Score [Time frame: Up to 3 years]
• QoL: EQ5D Score [Time frame: Up to 3 years]
• QoL: QLQ-NHL-HG29 Score [Time frame: Up to 3 years]
• Concentration of Duvelisib and its Metabolites in Blood [Time frame: Day 1 of Cycle 1 and Cycle 2 (predose and 60 minutes postdose)]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

France · 11 centers

• UNICANCER - Centre Henri-Becquerel — Rouen
• Institut Gustave Roussy — Villejuif
• CHU Cote de Nacre — Caen
• CHU Clermont-Ferrand — Clermont-Ferrand
• CHU Montpellier — Montpellier
• CHU Nantes — Nantes
• Hopital Pitie Salpetriere — Paris
• CHU Bordeaux — Pessac
• … and 3 more centers

United Kingdom · 7 centers

• The Royal Marsden NHS Foundation Trust — Sutton
• Beatson West of Scotland Cancer Centre — Glasgow
• University Hospitals of Leicester NHS Trust — Leicester
• UCLH NHS Foundation Trust — London
• The Christie NHS Foundation Trust — Manchester
• Nottingham University Hospitals NHS Trust — Nottingham
• Oxford University Hospitals NHS Foundation Trust — Oxford

Italy · 5 centers

• Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo - Alessandria — Alessandria
• Asst Papa Giovanni Xxiii Uo Ematologia — Bergamo
• Azienda Ospedaliero-Universitaria di Bologna — Bologna
• Ematologia Oncologia Instituto Pascale — Naples
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome

Germany · 4 centers

• Evangelisches Krankenhaus Essen-Werden — Essen
• Universitaetsmedizin Goettingen (UMG) - Klinik fuer Haematologie und Medizinische Onkologi — Goettigen
• Universitaetsklinikum Halle (Saale) — Halle
• Universitaetsklinikum Leipzig- Klinik und Poliklinik fuer Haematologie und Zelltherapie — Leipzig

Poland · 4 centers

• Uniwersyteckie Centrum Kliniczne Oddzial Hematologii i Transplantologii — Gdansk
• Pratia Centrum Medyczne Krakow — Krakow
• Instytut Hematologii i Transfuzjologii — Warsaw
• Narodowy Instytut Onkologii im. Marii Skłodowskiej - Curie — Warsaw

Spain · 4 centers

• ICO Hospitalet (Hospital Duran i Reynals) — Barcelona
• Hospital Universitario Fundacion Jimenez Diaz — Madrid
• Hospital Clinico Universitario de Salamanca — Salamanca
• Hospital Universitario Virgen del Rocio — Seville

Denmark · 3 centers

• Aarhus University Hospital — Aarhus
• Rigshospitalet Copenhagen — Copenhagen
• Odense Hospital — Odense

Netherlands · 3 centers

• Amsterdam UMC location AMC — Amsterdam
• Leiden University Medical Center (LUMC) — Leiden
• Erasmus University Medical Center — Rotterdam

Belgium · 2 centers

• Universitair Ziekenhuis Gent (UZ Gent) — Ghent
• UZ Leuven - Gasthuisberg Campus — Leuven

Czechia · 1 center

• Vseobecna fakultni nemocnice — Prague

Identifiers

NCT: NCT06522737 · SBI-0145-304 · 2024-516605-23-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗