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

NCT06522737 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: SBI-0145-3042024-516605-23-00
• Study Type: interventional
• Target: 124
• Locations: 10 countries
• Sites: 43

Brief Summary

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.

Conditions

Lymphoma

Keywords

Nodal T Cell Lymphoma; T Follicular Helper; Relapsed/Refractory; Duvelisib; Peripheral T cell lymphoma; Angioimmunoblastic T cell lymphoma; TERZO; 145-304; TFH

Outcome Measures

Primary Outcomes (1)

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

  Up to 3 years

Secondary Outcomes (12)

• Overall Survival (OS)

  Up to 3 years

• PFS as assessed by the investigator

  Up to 3 years

• Objective Response Rate (ORR) as assessed by the IRC

  Up to 3 years

• Complete Response Rate (CRR) as assessed by the IRC

  Up to 3 years

• Duration of Response (DOR) as assessed by the IRC

  Up to 3 years

Study Arms (2)

Duvelisib

EXPERIMENTAL

Duvelisib will be administered orally twice daily (BID) in 28-day cycles.

Drug: Duvelisib

Gemcitabine or Bendamustine

ACTIVE COMPARATOR

Participants will receive the investigator's choice of gemcitabine or bendamustine. The regimen to be used after randomization must be selected by the investigator prior to randomization. Gemcitabine will be administered intravenously (IV) on days 1, 8, and 15 of each 28-day cycle for up to 6 cycles. Bendamustine will be administered IV on days 1 and 2 of each 21-day cycle for up to 6 cycles.

Drug: Gemcitabine; Drug: Bendamustine

Interventions

Gemcitabine DRUG

solution for intravenous infusion

Gemcitabine or Bendamustine

Bendamustine DRUG

solution for intravenous infusion

Gemcitabine or Bendamustine

Duvelisib DRUG

oral capsules

Duvelisib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SecuraBio: lead

Study Sites (43)

Universitair Ziekenhuis Gent (UZ Gent)

Ghent, 9000, Belgium

NOT YET RECRUITING

UZ Leuven - Gasthuisberg Campus

Leuven, 3000, Belgium

RECRUITING

Vseobecna fakultni nemocnice

Prague, 128 08, Czechia

RECRUITING

Aarhus University Hospital

Aarhus, DK-8200, Denmark

NOT YET RECRUITING

Rigshospitalet Copenhagen

Copenhagen, DK-2100, Denmark

RECRUITING

Odense Hospital

Odense, DK-5000, Denmark

RECRUITING

UNICANCER - Centre Henri-Becquerel

Rouen, Normandy, 76038 Cedex 1, France

NOT YET RECRUITING

Institut Gustave Roussy

Villejuif, Vaillant, 94805, France

RECRUITING

CHU Cote de Nacre

Caen, 14033, France

NOT YET RECRUITING

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

CHU Montpellier

Montpellier, 34295, France

RECRUITING

CHU Nantes

Nantes, 44093, France

RECRUITING

Hopital Pitie Salpetriere

Paris, 75019, France

RECRUITING

CHU Bordeaux

Pessac, 33604, France

RECRUITING

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

NOT YET RECRUITING

CHU PONTCHAILLOU-Haematology

Rennes, France

NOT YET RECRUITING

Institut Curie Paris

Saint-Cloud, 92210, France

NOT YET RECRUITING

Evangelisches Krankenhaus Essen-Werden

Essen, 45239, Germany

NOT YET RECRUITING

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

Goettigen, 37075, Germany

NOT YET RECRUITING

Universitaetsklinikum Halle (Saale)

Halle, 06120, Germany

NOT YET RECRUITING

Universitaetsklinikum Leipzig- Klinik und Poliklinik fuer Haematologie und Zelltherapie

Leipzig, 04103, Germany

NOT YET RECRUITING

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

Alessandria, 15121, Italy

RECRUITING

Asst Papa Giovanni Xxiii Uo Ematologia

Bergamo, 24127, Italy

RECRUITING

Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

Ematologia Oncologia Instituto Pascale

Naples, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

Amsterdam UMC location AMC

Amsterdam, 1105 AZ, Netherlands

NOT YET RECRUITING

Erasmus University Medical Center

Rotterdam, 3015GD, Netherlands

RECRUITING

Uniwersyteckie Centrum Kliniczne Oddzial Hematologii i Transplantologii

Gdansk, 80-214, Poland

NOT YET RECRUITING

Pratia Centrum Medyczne Krakow

Krakow, 30-727, Poland

RECRUITING

Instytut Hematologii i Transfuzjologii

Warsaw, 02-776, Poland

RECRUITING

Narodowy Instytut Onkologii im. Marii Skłodowskiej - Curie

Warsaw, 02-781, Poland

NOT YET RECRUITING

ICO Hospitalet (Hospital Duran i Reynals)

Barcelona, 08908, Spain

RECRUITING

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 37007, Spain

RECRUITING

Hospital Clinico Universitario de Salamanca

Salamanca, 58182, Spain

RECRUITING

Hospital Universitario Virgen del Rocio

Seville, Spain

RECRUITING

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

NOT YET RECRUITING

University Hospitals of Leicester NHS Trust

Leicester, LE1 5WW, United Kingdom

RECRUITING

UCLH NHS Foundation Trust

London, NW1 2PG, United Kingdom

RECRUITING

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

RECRUITING

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

RECRUITING

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 7LE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Lymphoma; Recurrence; Lymphoma, T-Cell, Peripheral; Immunoblastic Lymphadenopathy

Interventions

duvelisib; Gemcitabine; Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Ohad Bentur

CONTACT

(702) 254-0011; TerzoMM@securabio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: May 19, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (7); NL (2); CZ (1); IT (5); DK (3); BE (2); PL (4); FR (11); DE (4); ES (4)