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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
Where Is This Study? (7 UK sites)
The Royal Marsden NHS Foundation Trust
Sutton SM2 5PT, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow G12 0YN, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester LE1 5WW, United Kingdom
UCLH NHS Foundation Trust
London NW1 2PG, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham NG5 1PB, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford OX3 7LE, United Kingdom
How to Get in Touch
Ohad Bentur
Sponsor contactCONTACT
