A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype
NCT ID: NCT06522737
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
124 participants
INTERVENTIONAL
2025-05-19
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Duvelisib
Duvelisib will be administered orally twice daily (BID) in 28-day cycles.
Duvelisib
oral capsules
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.
Gemcitabine
solution for intravenous infusion
Bendamustine
solution for intravenous infusion
Interventions
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Duvelisib
oral capsules
Gemcitabine
solution for intravenous infusion
Bendamustine
solution for intravenous infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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SecuraBio
INDUSTRY
Responsible Party
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Locations
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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
Evangelische Kliniken Essen-Mitte
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
Erasmus MC, Haematology Department
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-516605-23-00
Identifier Type: CTIS
Identifier Source: secondary_id
SBI-0145-304
Identifier Type: -
Identifier Source: org_study_id
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