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
Status: Recruiting
Location: See all (43) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Belgium
Universitair Ziekenhuis Gent (UZ Gent)
RECRUITING
Ghent
UZ Leuven - Gasthuisberg Campus
RECRUITING
Leuven
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Rigshospitalet Copenhagen
RECRUITING
Copenhagen
Odense Hospital
RECRUITING
Odense
France
CHU Cote de Nacre
RECRUITING
Caen
CHU Clermont-Ferrand
RECRUITING
Clermont-ferrand
CHU Montpellier
RECRUITING
Montpellier
CHU Nantes
RECRUITING
Nantes
Hopital Pitie Salpetriere
RECRUITING
Paris
CHU Bordeaux
RECRUITING
Pessac
Centre Hospitalier Lyon Sud
RECRUITING
Pierre-bénite
CHU PONTCHAILLOU-Haematology
RECRUITING
Rennes
UNICANCER - Centre Henri-Becquerel
RECRUITING
Rouen
Institut Curie Paris
RECRUITING
Saint-cloud
Institut Gustave Roussy
RECRUITING
Villejuif
Germany
Evangelisches Krankenhaus Essen-Werden
RECRUITING
Essen
Universitaetsmedizin Goettingen (UMG) - Klinik fuer Haematologie und Medizinische Onkologie
RECRUITING
Goettigen
Universitaetsklinikum Halle (Saale)
RECRUITING
Halle
Universitaetsklinikum Leipzig- Klinik und Poliklinik fuer Haematologie und Zelltherapie
RECRUITING
Leipzig
Italy
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo - Alessandria
RECRUITING
Alessandria
Asst Papa Giovanni Xxiii Uo Ematologia
RECRUITING
Bergamo
Azienda Ospedaliero-Universitaria di Bologna
RECRUITING
Bologna
Ematologia Oncologia Instituto Pascale
RECRUITING
Naples
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Rome
Netherlands
Amsterdam UMC location AMC
RECRUITING
Amsterdam
Leiden University Medical Center (LUMC)
RECRUITING
Leiden
Erasmus University Medical Center
RECRUITING
Rotterdam
Poland
Uniwersyteckie Centrum Kliniczne Oddzial Hematologii i Transplantologii
RECRUITING
Gdansk
Pratia Centrum Medyczne Krakow
RECRUITING
Krakow
Instytut Hematologii i Transfuzjologii
RECRUITING
Warsaw
Narodowy Instytut Onkologii im. Marii Skłodowskiej - Curie
RECRUITING
Warsaw
Spain
ICO Hospitalet (Hospital Duran i Reynals)
RECRUITING
Barcelona
Hospital Universitario Fundacion Jimenez Diaz
RECRUITING
Madrid
Hospital Clinico Universitario de Salamanca
RECRUITING
Salamanca
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
United Kingdom
Beatson West of Scotland Cancer Centre
RECRUITING
Glasgow
University Hospitals of Leicester NHS Trust
RECRUITING
Leicester
UCLH NHS Foundation Trust
RECRUITING
London
The Christie NHS Foundation Trust
RECRUITING
Manchester
Nottingham University Hospitals NHS Trust
RECRUITING
Nottingham
Oxford University Hospitals NHS Foundation Trust
RECRUITING
Oxford
The Royal Marsden NHS Foundation Trust
RECRUITING
Sutton
Contact Information
Primary
Ohad Bentur
TerzoMM@securabio.com
(702) 254-0011
Time Frame
Start Date: 2025-05-19
Estimated Completion Date: 2028-12
Participants
Target number of participants: 124
Treatments
Experimental: Duvelisib
Duvelisib will be administered orally twice daily (BID) in 28-day cycles.
Active_comparator: Gemcitabine or Bendamustine
Participants will receive the investigator's choice of gemcitabine or bendamustine. The regimen to be used after randomization must be selected by the investigator prior to randomization. Gemcitabine will be administered intravenously (IV) on days 1, 8, and 15 of each 28-day cycle for up to 6 cycles. Bendamustine will be administered IV on days 1 and 2 of each 21-day cycle for up to 6 cycles.
Related Therapeutic Areas
Sponsors
Leads: SecuraBio