NCT06522737RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- First submitted
- 22 Jul 2024
- Start date
- 19 May 2025
- Primary completion date
- Feb 2028
- Lead sponsor
- SecuraBio
- NCT number
- NCT06522737
- EU CT number
- 2024-516605-23-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 124
- From 19 May 2025 to the primary completion date, Feb 2028
- 47 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Cutaneous-only disease.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (47)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| KLINIKEN ESSEN SUED Evangelisches Krankenhaus Essen-Werden gGmbH Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Universitaetsmedizin Goettingen Coordinator of this site? Confirm its status | Goettingen | Germany | Recruiting |
| Martin-Luther-Universitaet Halle-Wittenberg Coordinator of this site? Confirm its status | Halle (Saale) | Germany | Recruiting |
| Universitaet Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Rotkreuzklinikum Muenchen gGmbH Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Region Midtjylland Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Centre Hospitalier Universitaire De Caen Normandie Coordinator of this site? Confirm its status | Caen Cedex 9 | France | Recruiting |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| Centre Hospitalier Universitaire De Rennes Coordinator of this site? Confirm its status | Rennes Cedex 9 | France | Recruiting |
| Centre Henri Becquerel Coordinator of this site? Confirm its status | Rouen Cedex | France | Recruiting |
| Institut Curie Coordinator of this site? Confirm its status | Saint-Cloud | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| Beatson West of Scotland Cancer Centre Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Recruiting |
| University Hospitals of Leicester NHS Trust Coordinator of this site? Confirm its status | Leicester | United Kingdom | Recruiting |
| UCLH NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| The Christie NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| Nottingham University Hospitals NHS Trust Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Recruiting |
| Oxford University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Oxford | United Kingdom | Recruiting |
| The Royal Marsden NHS Foundation Trust Coordinator of this site? Confirm its status | Sutton | United Kingdom | Recruiting |
| Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria Coordinator of this site? Confirm its status | Alexandria | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Leids Universitair Medisch Centrum (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Recruiting |
| Academisch Ziekenhuis Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Pratia S.A. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Instytut Hematologii I Transfuzjologii Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.