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 (32) 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
Denmark
Odense Hospital
NOT_YET_RECRUITING
Odense
France
CHU Cote de Nacre
NOT_YET_RECRUITING
Caen
CHU Clermont-Ferrand
NOT_YET_RECRUITING
Clermont-ferrand
CHU Montpellier
RECRUITING
Montpellier
CHU Nantes
NOT_YET_RECRUITING
Nantes
Hopital Pitie Salpetriere
NOT_YET_RECRUITING
Paris
CHU Bordeaux
RECRUITING
Pessac
Centre Hospitalier Lyon Sud
NOT_YET_RECRUITING
Pierre-bénite
CHU PONTCHAILLOU-Haematology
NOT_YET_RECRUITING
Rennes
UNICANCER - Centre Henri-Becquerel
NOT_YET_RECRUITING
Rouen
Institut Curie Paris
NOT_YET_RECRUITING
Saint-cloud
Institut Gustave Roussy
NOT_YET_RECRUITING
Villejuif
Germany
Universitaetsmedizin Goettingen (UMG) - Klinik fuer Haematologie und Medizinische Onkologie
NOT_YET_RECRUITING
Goettigen
Universitaetsklinikum Leipzig- Klinik und Poliklinik fuer Haematologie und Zelltherapie
NOT_YET_RECRUITING
Leipzig
Italy
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo - Alessandria
RECRUITING
Alessandria
Asst Papa Giovanni Xxiii Uo Ematologia
NOT_YET_RECRUITING
Bergamo
Azienda Ospedaliero-Universitaria di Bologna
RECRUITING
Bologna
Ematologia Oncologia Instituto Pascale
NOT_YET_RECRUITING
Naples
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Rome
Netherlands
Amsterdam UMC location AMC
NOT_YET_RECRUITING
Amsterdam
Erasmus MC, Haematology Department
NOT_YET_RECRUITING
Rotterdam
Poland
Pratia Centrum Medyczne Krakow
RECRUITING
Krakow
Spain
ICO Hospitalet (Hospital Duran i Reynals)
RECRUITING
Barcelona
Hospital Clinico Universitario de Salamanca
NOT_YET_RECRUITING
Salamanca
Hospital Universitario Virgen del Rocio
NOT_YET_RECRUITING
Seville
United Kingdom
Beatson West of Scotland Cancer Centre
NOT_YET_RECRUITING
Glasgow
University Hospitals of Leicester NHS Trust
NOT_YET_RECRUITING
Leicester
UCLH NHS Foundation Trust
RECRUITING
London
The Christie NHS Foundation Trust
NOT_YET_RECRUITING
Manchester
Nottingham University Hospitals NHS Trust
RECRUITING
Nottingham
Oxford University Hospitals NHS Foundation Trust
RECRUITING
Oxford
The Royal Marsden NHS Foundation Trust
NOT_YET_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