Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06522737

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

Led by SecuraBio · Updated on 2026-04-06

124

Participants Needed

44

Research Sites

184 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologically confirmed nodal T cell lymphoma with TFH phenotype according to WHO classification criteria including Angioimmunoblastic T cell lymphoma (AITL), follicular T cell lymphoma, and other nodal peripheral T cell lymphoma with 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 for T cell lymphoma
Not Eligible

You will not qualify if you...

  • Cutaneous-only disease
  • Received prior allogeneic transplant any time in the past or autologous transplant within 60 days prior to first dose of study drug
  • Received prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor
  • Prior exposure to planned study treatment (gemcitabine or bendamustine) within 60 days prior to first dose of study drug

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 44 locations

1

Universitair Ziekenhuis Gent (UZ Gent)

Ghent, Belgium, 9000

Actively Recruiting

2

UZ Leuven - Gasthuisberg Campus

Leuven, Belgium, 3000

Actively Recruiting

3

Vseobecna fakultni nemocnice

Prague, Czechia, 128 08

Actively Recruiting

4

Aarhus University Hospital

Aarhus, Denmark, DK-8200

Actively Recruiting

5

Rigshospitalet Copenhagen

Copenhagen, Denmark, DK-2100

Actively Recruiting

6

Odense Hospital

Odense, Denmark, DK-5000

Actively Recruiting

7

UNICANCER - Centre Henri-Becquerel

Rouen, Normandy, France, 76038 Cedex 1

Actively Recruiting

8

Institut Gustave Roussy

Villejuif, Vaillant, France, 94805

Actively Recruiting

9

CHU Cote de Nacre

Caen, France, 14033

Actively Recruiting

10

CHU Clermont-Ferrand

Clermont-Ferrand, France, 63000

Actively Recruiting

11

CHU Montpellier

Montpellier, France, 34295

Actively Recruiting

12

CHU Nantes

Nantes, France, 44093

Actively Recruiting

13

Hopital Pitie Salpetriere

Paris, France, 75019

Actively Recruiting

14

CHU Bordeaux

Pessac, France, 33604

Actively Recruiting

15

Centre Hospitalier Lyon Sud

Pierre-Bénite, France, 69310

Actively Recruiting

16

CHU PONTCHAILLOU-Haematology

Rennes, France

Actively Recruiting

17

Institut Curie Paris

Saint-Cloud, France, 92210

Actively Recruiting

18

Evangelisches Krankenhaus Essen-Werden

Essen, Germany, 45239

Actively Recruiting

19

Universitaetsmedizin Goettingen (UMG) - Klinik fuer Haematologie und Medizinische Onkologie

Goettigen, Germany, 37075

Actively Recruiting

20

Universitaetsklinikum Halle (Saale)

Halle, Germany, 06120

Actively Recruiting

21

Universitaetsklinikum Leipzig- Klinik und Poliklinik fuer Haematologie und Zelltherapie

Leipzig, Germany, 04103

Actively Recruiting

22

Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo - Alessandria

Alessandria, Italy, 15121

Actively Recruiting

23

Asst Papa Giovanni Xxiii Uo Ematologia

Bergamo, Italy, 24127

Actively Recruiting

24

Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy, 40138

Actively Recruiting

25

Ematologia Oncologia Instituto Pascale

Naples, Italy

Actively Recruiting

26

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy, 00168

Actively Recruiting

27

Amsterdam UMC location AMC

Amsterdam, Netherlands, 1105 AZ

Actively Recruiting

28

Leiden University Medical Center (LUMC)

Leiden, Netherlands, 2333 ZA

Actively Recruiting

29

Erasmus University Medical Center

Rotterdam, Netherlands, 3015GD

Actively Recruiting

30

Uniwersyteckie Centrum Kliniczne Oddzial Hematologii i Transplantologii

Gdansk, Poland, 80-214

Actively Recruiting

31

Pratia Centrum Medyczne Krakow

Krakow, Poland, 30-727

Actively Recruiting

32

Instytut Hematologii i Transfuzjologii

Warsaw, Poland, 02-776

Actively Recruiting

33

Narodowy Instytut Onkologii im. Marii Skłodowskiej - Curie

Warsaw, Poland, 02-781

Actively Recruiting

34

ICO Hospitalet (Hospital Duran i Reynals)

Barcelona, Spain, 08908

Actively Recruiting

35

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain, 37007

Actively Recruiting

36

Hospital Clinico Universitario de Salamanca

Salamanca, Spain, 58182

Actively Recruiting

37

Hospital Universitario Virgen del Rocio

Seville, Spain

Actively Recruiting

38

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom, SM2 5PT

Actively Recruiting

39

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom, G12 0YN

Actively Recruiting

40

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom, LE1 5WW

Actively Recruiting

41

UCLH NHS Foundation Trust

London, United Kingdom, NW1 2PG

Actively Recruiting

42

The Christie NHS Foundation Trust

Manchester, United Kingdom, M20 4BX

Actively Recruiting

43

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom, NG5 1PB

Actively Recruiting

44

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom, OX3 7LE

Actively Recruiting

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Research Team

O

Ohad Bentur

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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