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A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype
Sponsor: SecuraBio
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
124
Start Date
2025-05-19
Completion Date
2028-12
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
Duvelisib
oral capsules
Gemcitabine
solution for intravenous infusion
Bendamustine
solution for intravenous infusion
Locations (44)
Universitair Ziekenhuis Gent (UZ Gent)
Ghent, Belgium
UZ Leuven - Gasthuisberg Campus
Leuven, Belgium
Vseobecna fakultni nemocnice
Prague, Czechia
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet Copenhagen
Copenhagen, Denmark
Odense Hospital
Odense, Denmark
UNICANCER - Centre Henri-Becquerel
Rouen, Normandy, France
Institut Gustave Roussy
Villejuif, Vaillant, France
CHU Cote de Nacre
Caen, France
CHU Clermont-Ferrand
Clermont-Ferrand, France
CHU Montpellier
Montpellier, France
CHU Nantes
Nantes, France
Hopital Pitie Salpetriere
Paris, France
CHU Bordeaux
Pessac, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
CHU PONTCHAILLOU-Haematology
Rennes, France
Institut Curie Paris
Saint-Cloud, France
Evangelisches Krankenhaus Essen-Werden
Essen, Germany
Universitaetsmedizin Goettingen (UMG) - Klinik fuer Haematologie und Medizinische Onkologie
Goettigen, Germany
Universitaetsklinikum Halle (Saale)
Halle, Germany
Universitaetsklinikum Leipzig- Klinik und Poliklinik fuer Haematologie und Zelltherapie
Leipzig, Germany
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo - Alessandria
Alessandria, Italy
Asst Papa Giovanni Xxiii Uo Ematologia
Bergamo, Italy
Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy
Ematologia Oncologia Instituto Pascale
Naples, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
Amsterdam UMC location AMC
Amsterdam, Netherlands
Leiden University Medical Center (LUMC)
Leiden, Netherlands
Erasmus University Medical Center
Rotterdam, Netherlands
Uniwersyteckie Centrum Kliniczne Oddzial Hematologii i Transplantologii
Gdansk, Poland
Pratia Centrum Medyczne Krakow
Krakow, Poland
Instytut Hematologii i Transfuzjologii
Warsaw, Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej - Curie
Warsaw, Poland
ICO Hospitalet (Hospital Duran i Reynals)
Barcelona, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Hospital Clinico Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
UCLH NHS Foundation Trust
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom