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Clinical Trials in Denmark / NCT06522737
Recruiting Phase 3

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

NCT06522737 · tracked via the Priya Life Science Denmark tracker
Sponsor
SecuraBio
Phase
Phase 3
Started
2025-05-19
Last updated
2026-04-06

Condition(s) studied

Lymphoma

Investigational drug(s) / intervention(s)

Duvelisib →Gemcitabine →Bendamustine →

Duvelisib: oral capsules

Gemcitabine: solution for intravenous infusion

Bendamustine: solution for intravenous infusion

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: * 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. Key Exclusion Criteria: * Cutaneous-only disease. * 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.

Primary outcome measure(s)

Trial sites (44)

FacilityCityRegionStatus
Universitair Ziekenhuis Gent (UZ Gent) Ghent Belgium Recruiting
UZ Leuven - Gasthuisberg Campus Leuven Belgium Recruiting
Vseobecna fakultni nemocnice Prague Czechia Recruiting
Aarhus University Hospital Aarhus Denmark Recruiting
Rigshospitalet Copenhagen Copenhagen Denmark Recruiting
Odense Hospital Odense Denmark Recruiting
UNICANCER - Centre Henri-Becquerel Rouen Normandy Recruiting
Institut Gustave Roussy Villejuif Vaillant Recruiting
CHU Cote de Nacre Caen France Recruiting
CHU Clermont-Ferrand Clermont-Ferrand France Recruiting
CHU Montpellier Montpellier France Recruiting
CHU Nantes Nantes France Recruiting
Hopital Pitie Salpetriere Paris France Recruiting
CHU Bordeaux Pessac France Recruiting
Centre Hospitalier Lyon Sud Pierre-Bénite France Recruiting
CHU PONTCHAILLOU-Haematology Rennes France Recruiting
Institut Curie Paris Saint-Cloud France Recruiting
Evangelisches Krankenhaus Essen-Werden Essen Germany Recruiting
Universitaetsmedizin Goettingen (UMG) - Klinik fuer Haematologie und Medizinische Onkologie Goettigen Germany Recruiting
Universitaetsklinikum Halle (Saale) Halle Germany Recruiting
Universitaetsklinikum Leipzig- Klinik und Poliklinik fuer Haematologie und Zelltherapie Leipzig Germany Recruiting
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo - Alessandria Alessandria Italy Recruiting
Asst Papa Giovanni Xxiii Uo Ematologia Bergamo Italy Recruiting
Azienda Ospedaliero-Universitaria di Bologna Bologna Italy Recruiting
Ematologia Oncologia Instituto Pascale Naples Italy Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy Recruiting
Amsterdam UMC location AMC Amsterdam Netherlands Recruiting
Leiden University Medical Center (LUMC) Leiden Netherlands Recruiting
Erasmus University Medical Center Rotterdam Netherlands Recruiting
Uniwersyteckie Centrum Kliniczne Oddzial Hematologii i Transplantologii Gdansk Poland Recruiting
Pratia Centrum Medyczne Krakow Krakow Poland Recruiting
Instytut Hematologii i Transfuzjologii Warsaw Poland Recruiting
Narodowy Instytut Onkologii im. Marii Skłodowskiej - Curie Warsaw Poland Recruiting
ICO Hospitalet (Hospital Duran i Reynals) Barcelona Spain Recruiting
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain Recruiting
Hospital Clinico Universitario de Salamanca Salamanca Spain Recruiting
Hospital Universitario Virgen del Rocio Seville Spain Recruiting
The Royal Marsden NHS Foundation Trust Sutton Surrey Recruiting
Beatson West of Scotland Cancer Centre Glasgow United Kingdom Recruiting
University Hospitals of Leicester NHS Trust Leicester United Kingdom Recruiting

+ 4 more sites — see the full list on the official registry below.

Other trials for the same condition

REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs Recruiting
A Study to Evaluate the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma Active, not recruiting
Danish Elder Lymphoma Patient Hematopoietic Investigation Recruiting
Improving Genomic Profiling and Reducing Time to Cancer Treatment Via Targeted Use of Endoscopic Ultrasound Enrolling by invitation
Integrative Neuromuscular Training in Adolescents and Children Treated for Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06522737 on ClinicalTrials.gov ↗ ← All trials in Denmark