LymphomaPhase 3TERZONCT06522737
A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype
A Phase 3 study testing Duvelisib, Gemcitabine and Bendamustine in people with Lymphoma, run by SecuraBio at 44 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Duvelisib, Gemcitabine and Bendamustine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 44 sitesin 10 countries
- Study dates
- 19 May 2025to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
44 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
44 sites in 10 countries
France11 sites, 11 recruiting
- Recruiting
CHU Cote de Nacre
Caen, 14033
damaj-gl@chu-caen.fr
Gandhi Damaj
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63000
otournilhac@chu-clermontferrand.fr
Olivier Tournilhac
- Recruiting
CHU Montpellier
Montpellier, 34295
g-cartron@chu-montpellier.fr
Guillaume Cartron
- Recruiting
CHU Nantes
Nantes, 44093
benoit.tessoulin@chu-nantes.fr
Benoît Tessoulin
- Recruiting
Hopital Pitie Salpetriere
Paris, 75019
marine.baron@aphp.fr
Marine Baron
- Recruiting
CHU Bordeaux
Pessac, 33604
krimo.bouabdallah@chu-bordeaux.fr
Krimo Bouabdallah
- Recruiting
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
emmanuel.bachy@chu-lyon.fr
Emmanuel Bachy
- Recruiting
CHU PONTCHAILLOU-Haematology
Rennes
Roch.HOUOT@chu-rennes.fr
Roch Houot
- Recruiting
UNICANCER - Centre Henri-Becquerel
Rouen, Normandy, 76038 Cedex 1
vincent.camus@chb.unicancer.fr
Vincent Camus
- Recruiting
Institut Curie Paris
Saint-Cloud, 92210
carole.soussain@curie.fr
Carole Soussain
- Recruiting
Institut Gustave Roussy
Villejuif, Vaillant, 94805
vincent.ribrag@gustaveroussy.fr
Vincent Ribrag
United Kingdom7 sites, 7 recruiting
- Recruiting
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Matthew.Wilson@ggc.scot.nhs.uk
Matthew Wilson
- Recruiting
University Hospitals of Leicester NHS Trust
Leicester, LE1 5WW
mja40@leicester.ac.uk
Matthew Ahearne
- Recruiting
UCLH NHS Foundation Trust
London, NW1 2PG
kate.cwynarski@nhs.net
Kate Cwynarski
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
0161 446 3332, tim.illidge@manchester.ac.uk
Timothy Illidge
- Recruiting
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB
christopher.fox@nhs.net
Christopher Fox
- Recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE
graham.collins@ouh.nhs.uk
Graham Collins
- Recruiting
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
dima.el-sharkawi@rmh.nhs.uk
Dima El-Sharkawi
Italy5 sites, 5 recruiting
- Recruiting
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo - Alessandria
Alessandria, 15121
manuela.zanni@ospedale.al.it
Manuela Zanni
- Recruiting
Asst Papa Giovanni Xxiii Uo Ematologia
Bergamo, 24127
g.gritti@asst-pg23.it
Giuseppe Gritti
- Recruiting
Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
pierluigi.zinzani@unibo.it
Pier Luigi Zinzani
- Recruiting
Ematologia Oncologia Instituto Pascale
Naples
a.pinto@istitutotumori.na.it
Antonello Pinto
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168
stefan.hohaus@policlinicogemelli.it
Stefan Hohaus
Germany4 sites, 4 recruiting
- Recruiting
Evangelisches Krankenhaus Essen-Werden
Essen, 45239
p.reimer@kem-med.com
Peter Reimer
- Recruiting
Universitaetsmedizin Goettingen (UMG) - Klinik fuer Haematologie und Medizinische Onkologie
Goettigen, 37075
raphael.koch@med.uni-goettingen.de
Raphael Koch
- Recruiting
Universitaetsklinikum Halle (Saale)
Halle, 06120
thomas.weber@uk-halle.de
Thomas Weber
- Recruiting
Universitaetsklinikum Leipzig- Klinik und Poliklinik fuer Haematologie und Zelltherapie
Leipzig, 04103
marco.herling@medizin.uni-leipzig.de
Marco Herling
Poland4 sites, 4 recruiting
- Recruiting
Uniwersyteckie Centrum Kliniczne Oddzial Hematologii i Transplantologii
Gdansk, 80-214
jan.zaucha@gumed.edu.pl
Jan Zaucha
- Recruiting
Pratia Centrum Medyczne Krakow
Krakow, 30-727
wojciech.jurczak@lymphoma.edu.pl
Wojciech Jurczak
- Recruiting
Instytut Hematologii i Transfuzjologii
Warsaw, 02-776
akolkowska@ihit.waw.pl
Agnieszka Kolkowska-Lesiak
- Recruiting
Narodowy Instytut Onkologii im. Marii Skłodowskiej - Curie
Warsaw, 02-781
joanna.romejko-jarosinska@nio.gov.pl
Joanna Romejko-Jarosinska
Spain4 sites, 4 recruiting
- Recruiting
ICO Hospitalet (Hospital Duran i Reynals)
Barcelona, 08908
edomingo@iconcologia.net
Eva Domingo Domenech
- Recruiting
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 37007
sergio.ramos@quironsalud.es
Sergio Ramos
- Recruiting
Hospital Clinico Universitario de Salamanca
Salamanca, 58182
amartingar@usal.es
Alejandro Martin Garcia-Sancho
- Recruiting
Hospital Universitario Virgen del Rocio
Seville
fatimadelacruzv@gmail.com
Fatima de la Cruz
Denmark3 sites, 3 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, DK-8200
frandamo@rm.dk
Francesco A D'Amore
- Recruiting
Rigshospitalet Copenhagen
Copenhagen, DK-2100
peter.brown@regionh.dk
Peter Brown
- Recruiting
Odense Hospital
Odense, DK-5000
Peter.Braendstrup@rsyd.dk
Peter Braendstrup
Netherlands3 sites, 3 recruiting
- Recruiting
Amsterdam UMC location AMC
Amsterdam, 1105 AZ
ilse.kuipers@amsterdamumc.nl
Ilse Kuipers
- Recruiting
Leiden University Medical Center (LUMC)
Leiden, 2333 ZA
j.s.p.vermaat@lumc.nl
Joost Vermaat
- Recruiting
Erasmus University Medical Center
Rotterdam, 3015GD
y.serroukh@erasmusmc.nl
Yasmina Serroukh
Belgium2 sites, 2 recruiting
- Recruiting
Universitair Ziekenhuis Gent (UZ Gent)
Ghent, 9000
Ciel.DeVriendt@uzgent.be
Ciel Vriendt
- Recruiting
UZ Leuven - Gasthuisberg Campus
Leuven, 3000
koen.debackere@uzleuven.be
Koen Debackere
Czechia1 site, 1 recruiting
- Recruiting
Vseobecna fakultni nemocnice
Prague, 128 08
trneny@cesnet.cz
Marek Trneny
About this study
Official title: 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.
- Conditions
- Lymphoma
- Being tested
- Duvelisib, Gemcitabine, Bendamustine
- Keywords
- Nodal T Cell Lymphoma, T Follicular Helper, Relapsed/Refractory, Duvelisib, Peripheral T cell lymphoma, Angioimmunoblastic T cell lymphoma, TERZO, 145-304, TFH
- Medical subject headings
- Lymphoma, Recurrence, Lymphoma, T-Cell, Peripheral, Immunoblastic Lymphadenopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuvelisibDrug
oral capsules
GemcitabineDrug
solution for intravenous infusion
BendamustineDrug
solution for intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Duvelisib | Experimental | Duvelisib will be administered orally twice daily (BID) in 28-day cycles. Receives: Drug: Duvelisib |
| Gemcitabine or Bendamustine | Active comparator | 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. Receives: Drug: Gemcitabine; Drug: Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) as assessed by the Independent Review Committee (IRC)
Measured: Up to 3 years
Secondary outcomes (12)
Overall Survival (OS)
Measured: Up to 3 years
PFS as assessed by the investigator
Measured: Up to 3 years
Objective Response Rate (ORR) as assessed by the IRC
Measured: Up to 3 years
Complete Response Rate (CRR) as assessed by the IRC
Measured: Up to 3 years
Duration of Response (DOR) as assessed by the IRC
Measured: Up to 3 years
Proportion of participants who proceed to Stem Cell Transplantation (SCT)
Measured: Up to 3 years
Investigator-assessed PFS in participants who proceed to SCT
Measured: Up to 3 years
Number of participants with Adverse Events (AEs)
Measured: Up to 3 years
Quality of Life (QoL): European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Score
Measured: Up to 3 years
QoL: EQ5D Score
Measured: Up to 3 years
QoL: QLQ-NHL-HG29 Score
Measured: Up to 3 years
Concentration of Duvelisib and its Metabolites in Blood
Measured: Day 1 of Cycle 1 and Cycle 2 (predose and 60 minutes postdose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start19 May 2025
- Primary completionFeb 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SecuraBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522737
- Sponsor's protocol ID
- SBI-0145-304
- Other IDs
- 2024-516605-23-00
- Acronym
- TERZO
- Status last verified
- Apr 2026
- First submitted
- 22 Jul 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06522737
- Acronym / sponsor ID
- TERZO / SBI-0145-304
- Conditions
- Lymphoma
- Keywords
- Nodal T Cell Lymphoma, T Follicular Helper, Relapsed/Refractory, Duvelisib, Peripheral T cell lymphoma, Angioimmunoblastic T cell lymphoma, TERZO, 145-304
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- SecuraBioIndustry (pharma, biotech, devices)
- Study start
- 19 May 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duvelisib | Experimental | Drug: DuvelisibDuvelisib will be administered orally twice daily (BID) in 28-day cycles. |
| Gemcitabine or Bendamustine | Active comparator | Drug: Gemcitabine, Drug: BendamustineParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duvelisiboral capsules | Drug | Duvelisib |
| Gemcitabinesolution for intravenous infusion | Drug | Gemcitabine or Bendamustine |
| Bendamustinesolution for intravenous infusion | Drug | Gemcitabine or Bendamustine |
Primary outcome
Progression-free Survival (PFS) as assessed by the Independent Review Committee (IRC)
Time frame: Up to 3 years
12 secondary outcomes
Overall Survival (OS)
Time frame: Up to 3 years
PFS as assessed by the investigator
Time frame: Up to 3 years
Objective Response Rate (ORR) as assessed by the IRC
Time frame: Up to 3 years
Complete Response Rate (CRR) as assessed by the IRC
Time frame: Up to 3 years
Duration of Response (DOR) as assessed by the IRC
Time frame: Up to 3 years
Proportion of participants who proceed to Stem Cell Transplantation (SCT)
Time frame: Up to 3 years
Investigator-assessed PFS in participants who proceed to SCT
Time frame: Up to 3 years
Number of participants with Adverse Events (AEs)
Time frame: 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
QoL: EQ5D Score
Time frame: Up to 3 years
QoL: QLQ-NHL-HG29 Score
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
44 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Duvelisib, Gemcitabine and Bendamustine in people with Lymphoma, run by SecuraBio at 44 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in France, United Kingdom, Italy, Germany, Poland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ohad Bentur ((702) 254-0011, TerzoMM@securabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) as assessed by the Independent Review Committee (IRC) (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.