RecruitingPhase 3NCT06522737

A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype

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

Sponsor

SecuraBio

Enrollment

124 participants

Start Date

May 19, 2025

Study Type

INTERVENTIONAL

Conditions

Lymphoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing a targeted drug called duvelisib (a PI3K inhibitor) against standard chemotherapy (gemcitabine or bendamustine) in people with a type of T-cell lymphoma that has come back or stopped responding to prior treatment. **You may be eligible if...** - You have been diagnosed with a nodal T-cell lymphoma with TFH (T follicular helper) features, such as angioimmunoblastic T-cell lymphoma (AITL) or related types - Your lymphoma has relapsed or did not respond to at least one prior systemic chemotherapy regimen - You have measurable disease on imaging **You may NOT be eligible if...** - Your lymphoma only affects the skin - You previously had an allogeneic (donor) stem cell transplant, or an autologous transplant within the past 60 days - You have previously been treated with a PI3K inhibitor - You received gemcitabine or bendamustine within the past 60 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDuvelisib

oral capsules

DRUGGemcitabine

solution for intravenous infusion

DRUGBendamustine

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06522737

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