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New hope for rare lymphoma: duvelisib faces off against standard chemo

NCT ID NCT06522737

Disease control Sponsor: SecuraBio Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests the drug duvelisib against two standard chemotherapy drugs (gemcitabine or bendamustine) in 124 people with a rare type of lymphoma (nodal T cell lymphoma with TFH phenotype) that has returned or not responded to prior treatment. The main goal is to see if duvelisib helps people live longer without their cancer getting worse. Participants are randomly assigned to receive either duvelisib pills or one of the chemo drugs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Duvelisib (oral capsules)
What this could lead to
If successful, duvelisib could offer a new, more effective treatment option for people with this rare type of lymphoma that has stopped responding to standard chemotherapy.
What could go wrong
This is a phase 3 trial, but it's still experimental. Duvelisib may not prove better than current treatments, and side effects like infections or liver issues are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 124 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

angioimmunoblastic T-cell lymphoma lymphoma mature T-cell and NK-cell non-Hodgkin lymphoma Nodal T-follicular helper cell lymphoma, follicular type Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    44 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aarhus University Hospital

    RECRUITING

    Aarhus, DK-8200, Denmark

  • Amsterdam UMC location AMC

    RECRUITING

    Amsterdam, 1105 AZ, Netherlands

  • Asst Papa Giovanni Xxiii Uo Ematologia

    RECRUITING

    Bergamo, 24127, Italy

  • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo - Alessandria

    RECRUITING

    Alessandria, 15121, Italy

  • Azienda Ospedaliero-Universitaria di Bologna

    RECRUITING

    Bologna, 40138, Italy

  • Beatson West of Scotland Cancer Centre

    RECRUITING

    Glasgow, G12 0YN, United Kingdom

  • CHU Bordeaux

    RECRUITING

    Pessac, 33604, France

  • CHU Clermont-Ferrand

    RECRUITING

    Clermont-Ferrand, 63000, France

  • CHU Cote de Nacre

    RECRUITING

    Caen, 14033, France

  • CHU Montpellier

    RECRUITING

    Montpellier, 34295, France

  • CHU Nantes

    RECRUITING

    Nantes, 44093, France

  • CHU PONTCHAILLOU-Haematology

    RECRUITING

    Rennes, France

  • Centre Hospitalier Lyon Sud

    RECRUITING

    Pierre-Bénite, 69310, France

  • Ematologia Oncologia Instituto Pascale

    RECRUITING

    Naples, Italy

  • Erasmus University Medical Center

    RECRUITING

    Rotterdam, 3015GD, Netherlands

  • Evangelisches Krankenhaus Essen-Werden

    RECRUITING

    Essen, 45239, Germany

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Rome, 00168, Italy

  • Hopital Pitie Salpetriere

    RECRUITING

    Paris, 75019, France

  • Hospital Clinico Universitario de Salamanca

    RECRUITING

    Salamanca, 58182, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    RECRUITING

    Madrid, 37007, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, Spain

  • ICO Hospitalet (Hospital Duran i Reynals)

    RECRUITING

    Barcelona, 08908, Spain

  • Institut Curie Paris

    RECRUITING

    Saint-Cloud, 92210, France

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, Vaillant, 94805, France

  • Instytut Hematologii i Transfuzjologii

    RECRUITING

    Warsaw, 02-776, Poland

  • Leiden University Medical Center (LUMC)

    RECRUITING

    Leiden, 2333 ZA, Netherlands

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej - Curie

    RECRUITING

    Warsaw, 02-781, Poland

  • Nottingham University Hospitals NHS Trust

    RECRUITING

    Nottingham, NG5 1PB, United Kingdom

  • Odense Hospital

    RECRUITING

    Odense, DK-5000, Denmark

  • Oxford University Hospitals NHS Foundation Trust

    RECRUITING

    Oxford, OX3 7LE, United Kingdom

  • Pratia Centrum Medyczne Krakow

    RECRUITING

    Krakow, 30-727, Poland

  • Rigshospitalet Copenhagen

    RECRUITING

    Copenhagen, DK-2100, Denmark

  • The Christie NHS Foundation Trust

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The Royal Marsden NHS Foundation Trust

    RECRUITING

    Sutton, Surrey, SM2 5PT, United Kingdom

  • UCLH NHS Foundation Trust

    RECRUITING

    London, NW1 2PG, United Kingdom

  • UNICANCER - Centre Henri-Becquerel

    RECRUITING

    Rouen, Normandy, 76038 Cedex 1, France

  • UZ Leuven - Gasthuisberg Campus

    RECRUITING

    Leuven, 3000, Belgium

  • Universitaetsklinikum Halle (Saale)

    RECRUITING

    Halle, 06120, Germany

  • Universitaetsklinikum Leipzig- Klinik und Poliklinik fuer Haematologie und Zelltherapie

    RECRUITING

    Leipzig, 04103, Germany

  • Universitaetsmedizin Goettingen (UMG) - Klinik fuer Haematologie und Medizinische Onkologie

    RECRUITING

    Goettigen, 37075, Germany

  • Universitair Ziekenhuis Gent (UZ Gent)

    RECRUITING

    Ghent, 9000, Belgium

  • University Hospitals of Leicester NHS Trust

    RECRUITING

    Leicester, LE1 5WW, United Kingdom

  • Uniwersyteckie Centrum Kliniczne Oddzial Hematologii i Transplantologii

    RECRUITING

    Gdansk, 80-214, Poland

  • Vseobecna fakultni nemocnice

    RECRUITING

    Prague, 128 08, Czechia

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