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

April 3, 2026 updated by: SecuraBio

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

124

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Recruiting
        • Universitair Ziekenhuis Gent (Uz Gent)
        • Contact:
        • Principal Investigator:
          • Ciel Vriendt
      • Leuven, Belgium, 3000
  • Czechia
      • Prague, Czechia, 128 08
        • Recruiting
        • Vseobecna Fakultní Nemocnice
        • Principal Investigator:
          • Marek Trneny
        • Contact:
  • Denmark
      • Aarhus, Denmark, DK-8200
        • Recruiting
        • Aarhus University Hospital
        • Contact:
        • Principal Investigator:
          • Francesco A D'Amore
      • Copenhagen, Denmark, DK-2100
        • Recruiting
        • Rigshospitalet Copenhagen
        • Principal Investigator:
          • Peter Brown
        • Contact:
      • Odense, Denmark, DK-5000
  • France
      • Caen, France, 14033
        • Recruiting
        • CHU Côte de Nacre
        • Contact:
        • Principal Investigator:
          • Gandhi Damaj
      • Clermont-Ferrand, France, 63000
      • Montpellier, France, 34295
      • Nantes, France, 44093
      • Paris, France, 75019
        • Recruiting
        • Hôpital Pitié Salpêtrière
        • Contact:
        • Principal Investigator:
          • Marine Baron
      • Pessac, France, 33604
      • Pierre-Bénite, France, 69310
      • Rennes, France
      • Saint-Cloud, France, 92210
    • Normandy
      • Rouen, Normandy, France, 76038 Cedex 1
    • Vaillant
      • Villejuif, Vaillant, France, 94805
  • Germany
      • Essen, Germany, 45239
        • Recruiting
        • Evangelisches Krankenhaus Essen-Werden
        • Contact:
        • Principal Investigator:
          • Peter Reimer
      • Goettigen, Germany, 37075
        • Recruiting
        • Universitaetsmedizin Goettingen (UMG) - Klinik fuer Haematologie und Medizinische Onkologie
        • Principal Investigator:
          • Raphael Koch
        • Contact:
      • Halle, Germany, 06120
        • Recruiting
        • Universitaetsklinikum Halle (Saale)
        • Contact:
        • Principal Investigator:
          • Thomas Weber
      • Leipzig, Germany, 04103
        • Recruiting
        • Universitaetsklinikum Leipzig- Klinik und Poliklinik fuer Haematologie und Zelltherapie
        • Contact:
        • Principal Investigator:
          • Marco Herling
  • Italy
      • Alessandria, Italy, 15121
        • Recruiting
        • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo - Alessandria
        • Principal Investigator:
          • Manuela Zanni
        • Contact:
      • Bergamo, Italy, 24127
        • Recruiting
        • Asst Papa Giovanni Xxiii Uo Ematologia
        • Contact:
        • Principal Investigator:
          • Giuseppe Gritti
      • Bologna, Italy, 40138
        • Recruiting
        • Azienda Ospedaliero-Universitaria di Bologna
        • Principal Investigator:
          • Pier Luigi Zinzani
        • Contact:
      • Naples, Italy
      • Rome, Italy, 00168
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
      • Leiden, Netherlands, 2333 ZA
        • Recruiting
        • Leiden University Medical Center (LUMC)
        • Contact:
        • Principal Investigator:
          • Joost Vermaat
      • Rotterdam, Netherlands, 3015GD
        • Recruiting
        • Erasmus University Medical Center
        • Contact:
        • Principal Investigator:
          • Yasmina Serroukh
  • Poland
      • Gdansk, Poland, 80-214
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne Oddzial Hematologii i Transplantologii
        • Principal Investigator:
          • Jan Zaucha
        • Contact:
      • Krakow, Poland, 30-727
      • Warsaw, Poland, 02-776
        • Recruiting
        • Instytut Hematologii i Transfuzjologii
        • Contact:
        • Principal Investigator:
          • Agnieszka Kolkowska-Lesiak
      • Warsaw, Poland, 02-781
  • Spain
      • Barcelona, Spain, 08908
        • Recruiting
        • ICO Hospitalet (Hospital Duran i Reynals)
        • Principal Investigator:
          • EVA DOMINGO DOMENECH
        • Contact:
      • Madrid, Spain, 37007
        • Recruiting
        • Hospital Universitario Fundacion Jimenez Diaz
        • Contact:
        • Principal Investigator:
          • Sergio Ramos
      • Salamanca, Spain, 58182
        • Recruiting
        • Hospital Clínico Universitario de Salamanca
        • Principal Investigator:
          • Alejandro Martin Garcia-Sancho
        • Contact:
      • Seville, Spain
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Principal Investigator:
          • Fatima de la Cruz
        • Contact:
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
      • Leicester, United Kingdom, LE1 5WW
        • Recruiting
        • University Hospitals of Leicester NHS Trust
        • Contact:
        • Principal Investigator:
          • Matthew Ahearne
      • London, United Kingdom, NW1 2PG
        • Recruiting
        • UCLH NHS Foundation Trust
        • Principal Investigator:
          • Kate Cwynarski
        • Contact:
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie NHS Foundation Trust
        • Principal Investigator:
          • Timothy Illidge
        • Contact:
      • Nottingham, United Kingdom, NG5 1PB
        • Recruiting
        • Nottingham University Hospitals NHS Trust
        • Contact:
        • Principal Investigator:
          • Christopher Fox
      • Oxford, United Kingdom, OX3 7LE
        • Recruiting
        • Oxford University Hospitals NHS Foundation Trust
        • Principal Investigator:
          • Graham Collins
        • Contact:
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • The Royal Marsden NHS Foundation Trust
        • Principal Investigator:
          • Dima El-Sharkawi
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Duvelisib
Duvelisib will be administered orally twice daily (BID) in 28-day cycles.
Drug: Duvelisib
oral capsules
Active Comparator: 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.
Drug: Gemcitabine
solution for intravenous infusion
Drug: Bendamustine
solution for intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free Survival (PFS) as assessed by the Independent Review Committee (IRC)
Time Frame: Up to 3 years
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Up to 3 years
Up to 3 years
PFS as assessed by the investigator
Time Frame: Up to 3 years
Up to 3 years
Objective Response Rate (ORR) as assessed by the IRC
Time Frame: Up to 3 years
Up to 3 years
Complete Response Rate (CRR) as assessed by the IRC
Time Frame: Up to 3 years
Up to 3 years
Duration of Response (DOR) as assessed by the IRC
Time Frame: Up to 3 years
Up to 3 years
Proportion of participants who proceed to Stem Cell Transplantation (SCT)
Time Frame: Up to 3 years
Up to 3 years
Investigator-assessed PFS in participants who proceed to SCT
Time Frame: Up to 3 years
Up to 3 years
Number of participants with Adverse Events (AEs)
Time Frame: Up to 3 years
Up to 3 years
Quality of Life (QoL): European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Score
Time Frame: Up to 3 years
Up to 3 years
QoL: EQ5D Score
Time Frame: Up to 3 years
Up to 3 years
QoL: QLQ-NHL-HG29 Score
Time Frame: Up to 3 years
Up to 3 years
Concentration of Duvelisib and its Metabolites in Blood
Time Frame: Day 1 of Cycle 1 and Cycle 2 (predose and 60 minutes postdose)
Day 1 of Cycle 1 and Cycle 2 (predose and 60 minutes postdose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SecuraBio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

July 22, 2024

First Submitted That Met QC Criteria

July 22, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBI-0145-304
  • 2024-516605-23-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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