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NCT Number: NCT06522737

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

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.

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Key information

Conditions

Lymphoma Disease Attributes Hemic and Lymphatic Diseases Immune System Diseases Immunoblastic Lymphadenopathy Immunoproliferative Disorders Lymphadenopathy Lymphatic Diseases Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universitair Ziekenhuis Gent (UZ Gent), Ghent, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Duvelisib

Drug

oral capsules

Gemcitabine

Drug

solution for intravenous infusion

Bendamustine

Drug

solution for intravenous infusion

Primary outcomes

  1. Progression-free Survival (PFS) as assessed by the Independent Review Committee (IRC)

    Time frame: Up to 3 years

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 3 years

  2. PFS as assessed by the investigator

    Time frame: Up to 3 years

  3. Objective Response Rate (ORR) as assessed by the IRC

    Time frame: Up to 3 years

  4. Complete Response Rate (CRR) as assessed by the IRC

    Time frame: Up to 3 years

  5. Duration of Response (DOR) as assessed by the IRC

    Time frame: Up to 3 years

  6. Proportion of participants who proceed to Stem Cell Transplantation (SCT)

    Time frame: Up to 3 years

  7. Investigator-assessed PFS in participants who proceed to SCT

    Time frame: Up to 3 years

  8. Number of participants with Adverse Events (AEs)

    Time frame: Up to 3 years

  9. Quality of Life (QoL): European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Score

    Time frame: Up to 3 years

  10. QoL: EQ5D Score

    Time frame: Up to 3 years

  11. QoL: QLQ-NHL-HG29 Score

    Time frame: Up to 3 years

  12. Concentration of Duvelisib and its Metabolites in Blood

    Time frame: Day 1 of Cycle 1 and Cycle 2 (predose and 60 minutes postdose)

Study contacts

Contact information is provided by the study sponsor or research team.

Ohad Bentur

CONTACT

[email protected]

(702) 254-0011

Sponsors and collaborators

Lead sponsor

SecuraBio

Industry

Registry information

Official study title

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

Acronym: TERZO

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 26, 2024
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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