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Comparing duvelisib to gemcitabine or bendamustine for relapsed T cell lymphoma

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

Phase 3 Interventional SecuraBio · NCT06522737

This study is testing if a new treatment called duvelisib can help people with relapsed T cell lymphoma live longer without their disease getting worse compared to standard treatments like gemcitabine or bendamustine.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment124 (estimated)
Ages18 Years and up
SexAll
SponsorSecuraBio Industry-sponsored
Locations44 sites (Ghent and 43 other locations)
Trial IDNCT06522737 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of duvelisib, a targeted therapy, compared to standard treatments gemcitabine or bendamustine in patients with relapsed or refractory nodal T cell lymphoma that has a T follicular helper phenotype. Participants will be monitored for progression-free survival, which is the length of time during and after treatment that the patient lives without the disease worsening. The study aims to determine if duvelisib provides a significant benefit over the traditional therapies. It is a Phase 3 interventional trial, indicating a focus on confirming efficacy and safety in a larger patient population.

Who should consider this trial

Good fit: Ideal candidates are individuals with pathologically confirmed nodal T cell lymphoma with T follicular helper phenotype who have relapsed or are refractory to at least one prior systemic therapy.

Not a fit: Patients with cutaneous-only disease or those who have received prior treatments with specific therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with a specific type of relapsed T cell lymphoma.

How similar studies have performed: Other studies have shown promise with targeted therapies in similar conditions, but the specific approach of duvelisib in this context is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion 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 this trial is running

Ghent and 43 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions LymphomaNodal T Cell LymphomaT Follicular HelperRelapsed/RefractoryDuvelisibPeripheral T cell lymphomaAngioimmunoblastic T cell lymphomaTERZO
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.