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Looking for participantsPhase3

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

Sponsor: SecuraBio

NCT ID: NCT06522737

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Duvelisib (drug), Gemcitabine (drug), Bendamustine (drug)
How long the study runs
Study runs about 43 months (dates as stated)
About the drug or intervention
Duvelisib — drug: oral capsules · Gemcitabine — drug: solution for intravenous infusion · Bendamustine — drug: solution for intravenous infusion
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at people whose nodal T cell lymphoma (a cancer of the lymphatic system) with a T follicular helper (TFH) phenotype has come back or not responded to earlier treatment. It compares a medicine called duvelisib with two other medicines, gemcitabine or bendamustine, to see how well they work. The study is funded by SecuraBio.

Who can take part

  • You have a confirmed diagnosis of nodal T cell lymphoma with a TFH phenotype. This includes angioimmunoblastic T cell lymphoma (AITL), follicular T cell lymphoma, or other nodal peripheral T cell lymphoma (PTCL) with a TFH phenotype.
  • Your lymphoma has come back (relapsed) or has not responded to treatment (refractory) after at least 1 previous whole-body (systemic) treatment.
  • You have disease that can be measured on tests.

Who may not be able to

  • Your lymphoma is only in the skin.
  • You have had a stem cell transplant from a donor at any time, or your own stem cell transplant within 60 days before the first dose of study drug.
  • You have had a medicine called a phosphoinositide-3-kinase (PI3K) inhibitor before.
  • You had gemcitabine or bendamustine within 60 days before the first dose of study drug.

What taking part involves

  • • Taking the study medicine duvelisib, or one of two other medicines chosen by the study doctor: gemcitabine or bendamustine.

Time commitment: Not stated — ask the trial team about how many visits are needed, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
124
Started
2025-05-19
Last checked
2026-04

Plain English Summary

What is this study?

  • • Testing a new treatment for lymphoma
  • • Phase3 - 124 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with lymphoma

Where?

  • • Sutton - The Royal Marsden NHS Foundation Trust
  • • Glasgow - Beatson West of Scotland Cancer Centre
  • • Leicester - University Hospitals of Leicester NHS Trust
  • • London - UCLH NHS Foundation Trust
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Lymphoma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Relapsed or refractory to at least 1 prior systemic, cytotoxic therapy for T cell lymphoma.
  • ✓cancer that can be measured on scans as defined by Lugano 2014 criteria (Cheson 2014) for T cell lymphoma.

Who cannot take part

  • ✗Cutaneous-only disease.
  • ✗Received prior allogeneic transplant any time in the past or received autologous transplant within 60 days prior to...
  • ✗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...
  • ✗Other protocol-defined criteria apply.
See the full criteria
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.

Where Is This Study? (7 UK sites)

The Royal Marsden NHS Foundation Trust

Sutton SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Dima El-SharkawiPrincipal Investigator

Beatson West of Scotland Cancer Centre

Glasgow G12 0YN, United Kingdom

Recruiting
Site contact (verified)
Matthew WilsonPrincipal Investigator

University Hospitals of Leicester NHS Trust

Leicester LE1 5WW, United Kingdom

Recruiting
Site contact (verified)
Matthew AhearnePrincipal Investigator

UCLH NHS Foundation Trust

London NW1 2PG, United Kingdom

Recruiting
Site contact (verified)
Kate CwynarskiPrincipal Investigator

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Timothy IllidgePrincipal Investigator

Nottingham University Hospitals NHS Trust

Nottingham NG5 1PB, United Kingdom

Recruiting
Site contact (verified)
Christopher FoxPrincipal Investigator

Oxford University Hospitals NHS Foundation Trust

Oxford OX3 7LE, United Kingdom

Recruiting
Site contact (verified)
Graham CollinsPrincipal Investigator

How to Get in Touch

Ohad Bentur

Sponsor contact

CONTACT

(702) 254-0011 TerzoMM@securabio.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-04