RecruitingPHASE3INTERVENTIONAL

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

This research study is for people in the UK who have a type of blood cancer called T-cell lymphoma, specifically nodal T-cell lymphoma with a 'TFH' (T follicular helper) phenotype, which has either returned after treatment or didn't respond well to earlier therapies. The main aim is to see if a new drug, duvelisib, is better than existing standard treatments like gemcitabine or bendamustine. Researchers will compare how long patients live without their cancer growing or spreading when taking duvelisib versus the standard options. This is a Phase 3 study, meaning it's a later stage of research, often comparing a new treatment with a currently available one. The study hopes to find a more effective treatment option for this specific type of lymphoma.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

SecuraBio

Enrolment target

124

Start

19 May 2025

Estimated completion

01 Dec 2028

Lymphoma

What is this study about?

This research study, called a clinical trial, is looking at a new medicine for a type of blood cancer called T-cell lymphoma. Specifically, it's for people in the UK who have 'nodal T-cell lymphoma with TFH phenotype,' which means the cancer affects their lymph nodes and has certain features when looked at under a microscope. This study is for people whose lymphoma has either come back after previous treatments or didn't respond as well as hoped to those treatments.

The main goal of the study is to see if a drug called duvelisib is more effective than standard treatments like gemcitabine or bendamustine. Researchers want to find out if duvelisib can help people live longer without their cancer growing or getting worse. This is an important step in finding better ways to treat this specific type of lymphoma.

Duvelisib works differently from chemotherapy. It's a 'targeted therapy' that aims to block certain signals within cancer cells that help them grow and survive. By comparing it to existing treatments, the study hopes to offer new hope for patients looking for more options.

Key takeaways

New drug (duvelisib) being tested for specific T-cell lymphoma.
For lymphoma that has returned or not responded to previous treatment.
Compares duvelisib to standard treatments (gemcitabine/bendamustine).
Aims to find out if duvelisib can keep cancer from progressing longer.
Participation involves regular clinic visits and monitoring.
You can leave the study at any time.

Who may be eligible?

To join this study, you would need to be an adult, aged 18 or over. You must have a confirmed diagnosis of a specific type of T-cell lymphoma that affects your lymph nodes, such as Angioimmunoblastic T-cell lymphoma (AITL) or follicular T-cell lymphoma, or another type that shows certain features (TFH phenotype) when doctors examine it.

Also, your lymphoma must have either come back after at least one previous treatment, or it didn't respond to previous treatments. Doctors need to be able to measure your cancer, for example, by scans, to be able to see if the treatment is working.

There are also reasons why you might not be able to join. For example, if your lymphoma only affects your skin, or if you've recently had a stem cell transplant (within 60 days for your own cells, or any time for someone else's). You also can't have been treated with a similar type of drug called a PI3K inhibitor before, or received gemcitabine or bendamustine within the last 60 days, as these are the treatments being compared in the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of nodal T-cell lymphoma (with TFH features, like AITL)?
Has your lymphoma come back or not responded to prior treatments?
Has it been more than 60 days since you last had gemcitabine or bendamustine?
Have you never taken a similar drug called a PI3K inhibitor before?
Do you not have lymphoma that only affects your skin?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive either the new drug, duvelisib, or one of the standard treatments, gemcitabine or bendamustine. This is like flipping a coin, so neither you nor your doctor can choose which treatment you receive. You would take the assigned medication according to a specific schedule, which your study team will explain in detail.

Throughout the study, you would have regular visits to the clinic for medical check-ups, blood tests, and scans (like CT scans) to monitor your health and see how the treatment is working. The exact number and timing of these visits will be set out in the study plan. These appointments are important for your safety and to collect information about the treatment. The total duration of your participation in the study would depend on how your treatment is progressing and the study's design for follow-up.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing a new treatment that might be more effective than current options for your type of lymphoma. You will also be closely monitored by a team of medical professionals. However, there are also potential risks; all medications can have side effects, and duvelisib or the standard treatments might cause unwanted reactions. The specific side effects will be discussed in detail by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (44)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Universitair Ziekenhuis Gent (UZ Gent)
Verified postcode
Ghent, Belgium· Recruiting
UZ Leuven - Gasthuisberg Campus
Verified postcode
Leuven, Belgium· Recruiting
Vseobecna fakultni nemocnice
Verified postcode
Prague, Czechia· Recruiting
Aarhus University Hospital
Verified postcode
Aarhus, Denmark· Recruiting
Rigshospitalet Copenhagen
Verified postcode
Copenhagen, Denmark· Recruiting
Odense Hospital
Verified postcode
Odense, Denmark· Recruiting
UNICANCER - Centre Henri-Becquerel
Verified postcode
Rouen, France· Recruiting
Institut Gustave Roussy
Verified postcode
Villejuif, France· Recruiting
CHU Cote de Nacre
Verified postcode
Caen, France· Recruiting
CHU Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France· Recruiting
CHU Montpellier
Verified postcode
Montpellier, France· Recruiting
CHU Nantes
Verified postcode
Nantes, France· Recruiting

Common questions

What is nodal T-cell lymphoma with TFH phenotype?

It's a specific type of blood cancer that starts in certain white blood cells (T-cells) and often affects the lymph nodes, with particular features visible under a microscope.

What does 'relapsed or refractory' mean?

It means your cancer has either come back after previous treatment, or it didn't respond well to earlier treatments you received.

What is duvelisib?

Duvelisib is a new type of cancer medicine, sometimes called a 'targeted therapy,' that works differently from traditional chemotherapy.

Will I know which treatment I'm getting?

No, you will be randomly assigned to either duvelisib or one of the standard treatments, like a lottery system, so neither you nor your doctor chooses.

Can I stop participating in the study if I want to?

Yes, you can choose to leave the study at any time, for any reason, and it won't impact your future medical care.

How to find out more

Ohad Bentur

terzomm@securabio.com (702) 254-0011 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.