Clinical trial • Phase III • Oncology

Duvelisib for Nodal T-cell lymphoma with T follicular helper (TFH) phenotype | Angioimmunoblastic T-cell lymphoma (AITL) | Follicular T-cell lymphoma

Phase III trial of Duvelisib for Nodal T-cell lymphoma with T follicular helper (TFH) phenotype | Angioimmunoblastic T-cell lymphoma (AITL) | Follicular T…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Nodal T-cell lymphoma with T follicular helper (TFH) phenotype | Angioimmunoblastic T-cell lymphoma (AITL) | Follicular T-cell lymphoma
Trial Stage
Phase III
Drug Modality
Small molecule
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
29-11-2024
First CTIS Authorization Date
07-04-2025

Trial design

Randomised, open-label, investigator's choice of gemcitabine (intravenous; dose unit mg/m2; max daily dose amount recorded 1200 mg/m2) or bendamustine (intravenous; dose unit mg/m2; max daily dose amount recorded 120 mg/m2).-controlled Phase III trial across 39 sites in Germany, Spain, France and others.

Randomised
Yes
Open Label
Yes
Comparator
Investigator's choice of gemcitabine (intravenous; dose unit mg/m2; max daily dose amount recorded 1200 mg/m2) or bendamustine (intravenous; dose unit mg/m2; max daily dose amount recorded 120 mg/m2).
Target Sample Size
94
Trial Duration For Participant
1095

Eligibility

Recruits 94 Vulnerable population is selected for the trial. Subject information sheets and informed consent forms (L1_SIS and ICF) are provided (multiple country/language versions available). The JSON does not specify assent procedures or detailed consent-by-proxy arrangements..

Pregnancy Exclusion
Pregnant or breastfeeding
Vulnerable Population
Vulnerable population is selected for the trial. Subject information sheets and informed consent forms (L1_SIS and ICF) are provided (multiple country/language versions available). The JSON does not specify assent procedures or detailed consent-by-proxy arrangements.

Inclusion criteria

  • {"criterion_text":"- 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.\n- Relapsed or refractory to at least 1 prior systemic, cytotoxic therapy for T cell lymphoma.\n- Measurable disease as defined by Lugano 2014 criteria (Cheson 2014) for T cell lymphoma\n- ECOG Performance Status 0, 1 or 2\n- For women of childbearing potential (WOCBP): negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test within 3 days before first treatment\n- Male and female patients of reproductive potential must be willing to use a highly effective method* of contraception for the duration of study treatment and for the defined period following the last dose of the investigational medicinal product (IMP)"}

Exclusion criteria

  • {"criterion_text":"- Cutaneous-only disease\n- Received prior allogeneic transplant any time in the past or received autologous transplant within 60 days prior to the first dose of study drug\n- Received prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor\n- Prior exposure to planned study treatment investigator's choice therapy (gemcitabine or bendamustine) within 60 days prior to the first dose of study drug\n- Pregnant or breastfeeding\n- Eligible for high-dose therapy and subsequent allogeneic blood stem cell transplantation at the time of screening."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-free Survival (PFS) according to the Lugano 2014 criteria (Cheson 2014) as assessed by the Independent Review Committee (IRC) or death due to any cause - Up to 3 years","definition_or_measurement_approach":"PFS assessed by Independent Review Committee (IRC) using Lugano 2014 (Cheson 2014) criteria; follow-up up to 3 years."}

Secondary endpoints

  • {"endpoint_text":"- Overall Survival (OS) - Up to 3 years\n- PFS as assessed by the investigator - Up to 3 years\n- Objective Response Rate (ORR) as assessed by the IRC - Up to 3 years\n- Complete Response Rate (CRR) as assessed by the IRC - Up to 3 years\n- Duration of Response (DOR) as assessed by the IRC - Up to 3 years\n- Proportion of participants who proceed to Stem Cell Transplantation (SCT) - Up to 3 years\n- Investigator-assessed PFS in participants who proceed to SCT - Up to 3 years\n- Incidence/frequency of Adverse Events (AEs) and abnormal laboratory values - Up to 3 years\n- Quality of Life (QoL): European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Score - Up to 3 years\n- QoL: EQ5D Score - Up to 3 years\n- QoL: QLQ-NHL-HG29 Score - Up to 3 years\n- PK parameters derived from blood concentrations of duvelisib and its metabolites","definition_or_measurement_approach":"Endpoints are measured up to 3 years. OS = overall survival. PFS = per investigator or IRC as specified (Lugano 2014 criteria for IRC PFS). ORR/CRR/DOR assessed by IRC. QoL assessed by EORTC QLQ-C30, EQ-5D, QLQ-NHL-HG29 questionnaires. PK parameters from blood concentrations of duvelisib/metabolites."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
94
Recruitment Window Months
75
Consent Approach
Informed consent is obtained using subject information sheets and informed consent forms (L1_SIS and ICF) available in multiple country/language versions (DEU, ESP, FRA, ITA, NLD, CZE, POL, ENG, etc.). Pregnancy-specific ICFs are provided for women of childbearing potential. The JSON does not provide detailed age-specific assent procedures; participant provides consent as per the country-specific ICFs.

Methods

  • K1 recruitment arrangements documents available per country (e.g. K1_Recruitment arrangements_DEU, K1 Recruitment arrangements_ESP, K1_Recruitment arrangements_FRA, K1_Recruitment arrangements_DNK, K1_Recruitment arrangements_NLD, K1_Recruitment arrangements_ITA, K1_Recruitment arrangements_CZE, K1_Recruitment arrangements_BEL, K1_Recruitment arrangements_POL) — country-specific recruitment arrangements.
  • Leapcure digital campaign materials (K2) including campaign materials, pre-screener questionnaires, privacy policy, summary letters and patient journey documents (country-specific versions: DEU, ESP, ITA, POL, NLD, DNK, etc.).
  • Site-based recruitment via participating hospitals/clinical sites listed for each country (hospital contact details provided in trialSites).

Geography

Total Number Of Sites
39
Total Number Of Participants
94

Germany

Earliest CTIS Part Ii Submission Date
10-03-2025
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
400
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
Universitaetsmedizin Goettingen
Department Name
Klinik für Haematologie und Medizinische Onkologie
Contact Person Name
Raphael Koch
Site Name
KLINIKEN ESSEN SUED Evangelisches Krankenhaus Essen-Werden gGmbH
Department Name
Klinik für Haematologie, Internistische Onkologie und Stammzelltransplantation
Contact Person Name
Peter Reimer
Contact Person Email
P.Reimer@kem-med.com
Site Name
Martin-Luther-Universitaet Halle-Wittenberg
Department Name
Klinik für Innere Medizin IV, Haematologie und Onkologie
Contact Person Name
Thomas Weber
Contact Person Email
thomas.weber@uk-halle.de
Site Name
Universitaet Leipzig
Department Name
Klinik und Poliklinik für Hämatologie, Zelltherapie, Hämostaseologie und Infektiologie
Contact Person Name
Marco Herling

Spain

Earliest CTIS Part Ii Submission Date
10-03-2025
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
403
Number Of Sites
4
Number Of Participants
6

Sites

Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Hematología
Contact Person Name
Sergio Ramos
Contact Person Email
sergio.ramosc@quironsalud.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Hematologia
Contact Person Name
Fatima De la Cruz
Contact Person Email
fatimadelacruzv@gmail.com
Site Name
Institut Catala D'oncologia
Department Name
Hematology
Contact Person Name
Eva Domimgo Domenech
Contact Person Email
edomingo@iconcologia.net
Site Name
Hospital Universitario De Salamanca
Department Name
Hematology
Contact Person Name
Alejandro Martín García-Sancho
Contact Person Email
amartingar@usal.es

France

Earliest CTIS Part Ii Submission Date
10-03-2025
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
403
Number Of Sites
12
Number Of Participants
14

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hematology
Contact Person Name
Marine Baron
Contact Person Email
marine.baron@aphp.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Clinical Hematology
Contact Person Name
Roch Houot
Contact Person Email
roch.houot@chu-rennes.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Clinical Hematology and Cellular Therapy
Contact Person Name
Kamal-Krimo Bouabdallah
Site Name
Centre Henri Becquerel
Department Name
Hematology
Contact Person Name
Vincent Camus
Contact Person Email
Vincent.camus@chb.unicancer.fr
Site Name
Hospices Civils De Lyon
Department Name
Hematology
Contact Person Name
Emmanuel Bachy
Contact Person Email
emmanuel.bachy@chu-lyon.fr
Site Name
Institut Curie
Department Name
Hematology
Contact Person Name
Carole Soussain
Contact Person Email
carole.soussain@curie.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Hematology and Cellular Therapy
Contact Person Name
Olivier Tournilhac
Site Name
Institut Gustave Roussy
Department Name
Hematology
Contact Person Name
Vincent Ribrag
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Clinical Hematology
Contact Person Name
Benoit Tessoulin
Contact Person Email
benoit.tessoulin@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Clinical Hematology
Contact Person Name
Guillaume Cartron
Contact Person Email
g-cartron@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Hematology
Contact Person Name
Gandhi Laurent Damaj
Contact Person Email
damaj-gl@chu-caen.fr
Site Name
Institut Paoli Calmettes
Department Name
Hematology
Contact Person Name
Gabriel Brisou
Contact Person Email
brisoug@ipc.unicancer.fr

Denmark

Earliest CTIS Part Ii Submission Date
11-07-2025
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
276
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Region Midtjylland
Department Name
Hematology
Contact Person Name
Francesco d'Amore
Contact Person Email
frandamo@rm.dk
Site Name
Odense University Hospital
Department Name
Hematology
Contact Person Name
Peter Braendstrup
Contact Person Email
peter.braendstrup@rsyd.dk
Site Name
Rigshospitalet
Department Name
Hematology
Contact Person Name
Peter Brown
Contact Person Email
peter.brown@regionh.dk

Netherlands

Earliest CTIS Part Ii Submission Date
11-03-2025
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
398
Number Of Sites
4
Number Of Participants
6

Sites

Site Name
Academisch Ziekenhuis Maastricht
Department Name
Internal Medicine - Hematology
Contact Person Name
Marjolein van der Poel
Contact Person Email
research.hematologie@mumc.nl
Site Name
Amsterdam UMC Stichting
Department Name
Hematology
Contact Person Name
Ilse Kuipers
Contact Person Email
hematology@amsterdamumc.nl
Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Hematology
Contact Person Name
Joost Vermaat
Contact Person Email
j.s.p.vermaat@lumc.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Hematology
Contact Person Name
Yasmina Serroukh

Italy

Earliest CTIS Part Ii Submission Date
11-03-2025
Latest Decision Or Authorization Date
14-05-2026
Processing Time Days
429
Number Of Sites
5
Number Of Participants
22

Sites

Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Haematology
Contact Person Name
Antonio Pinto
Contact Person Email
a.pinto@istitutotumori.na.it
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
Haematology
Contact Person Name
Giuseppe Gritti
Contact Person Email
g.gritti@asst-pg23.it
Site Name
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Department Name
Haematology
Contact Person Name
Manuela Zanni
Contact Person Email
manuela.zanni@ospedale.al.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Haematology
Contact Person Name
Pier Luigi Zinzani
Contact Person Email
pierluigi.zinzani@unibo.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Haematology
Contact Person Name
Stefan Hohaus
Contact Person Email
stefan.hohaus@unicatt.it

Czechia

Earliest CTIS Part Ii Submission Date
10-03-2025
Latest Decision Or Authorization Date
14-05-2026
Processing Time Days
430
Number Of Sites
1
Number Of Participants
6

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
I. interni klinika - klinika hematologie 1. LF a VFN
Contact Person Name
Marek Trneny
Contact Person Email
trneny@cesnet.cz

Belgium

Earliest CTIS Part Ii Submission Date
25-06-2025
Latest Decision Or Authorization Date
14-05-2026
Processing Time Days
323
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Hematology
Contact Person Name
Ciel De Vriendt
Contact Person Email
ciel.devriendt@uzgent.be
Site Name
UZ Leuven
Department Name
Hematology
Contact Person Name
Koen Debackere
Contact Person Email
koen.debackere@uzleuven.be

Poland

Earliest CTIS Part Ii Submission Date
07-03-2025
Latest Decision Or Authorization Date
14-05-2026
Processing Time Days
433
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Instytut Hematologii I Transfuzjologii
Contact Person Name
Agnieszka Kołkowska- Lesiak
Contact Person Email
akolkowska@ihit.waw.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Contact Person Name
Jan Maciej Zaucha
Contact Person Email
jan.zaucha@gmail.com
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Contact Person Name
Joanna Romejko - Jarosińska
Site Name
Pratia S.A.
Contact Person Name
Wojciech Jurczak
Contact Person Email
wojciech.jurczak@pratia.com

Sponsor

Primary sponsor

Full Name
Secura Bio Limited
Organisation Type
Pharmaceutical company
Country Of Registered Address
Ireland

Contract research organisations

Name
Premier Research GmbH
Responsibilities
codes: 1,10,11,12,13,2,3,5,6,8
Name
CSI Clinical Services International GmbH
Responsibilities
code: 14
Name
PCI Pharma Services Germany GmbH
Responsibilities
code: 14

Third parties

  • {"country":"Germany","full_name":"PCI Pharma Services Germany GmbH","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Imaging Endpoints II LLC","duties_or_roles":"Central imaging review","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Premier Research GmbH","duties_or_roles":"codes: 1,10,11,12,13,2,3,5,6,8","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"CSI Clinical Services International GmbH","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient travel arrangement and reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"LabConnect GmbH","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code: 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Leapcure Inc.","duties_or_roles":"code: 2","organisation_type":"Industry"}
  • {"country":"United Kingdom","full_name":"Drug Development Solutions Limited","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
DUVELISIB
Active Substance
Duvelisib
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Commercial-source duvelisib (study-specific packaging) / commercial Copiktra product used; orphan designation EU/3/22/2730
Orphan Designation
Yes
Maximum Dose
150 mg (max daily dose amount recorded 150 mg)
Investigational Product Name
Copiktra 15 mg hard capsules
Active Substance
Duvelisib
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (EU marketing authorisation PRD9176341 / EU/1/21/1542/001)
Orphan Designation
Yes
Maximum Dose
150 mg (max daily dose amount recorded 150 mg)
Investigational Product Name
Copiktra 25 mg hard capsules
Active Substance
Duvelisib
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (EU marketing authorisation PRD9176342 / EU/1/21/1542/002)
Orphan Designation
Yes
Maximum Dose
150 mg (max daily dose amount recorded 150 mg)
Investigational Product Name
BENDAMUSTINE
Active Substance
Bendamustine hydrochloride
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (SmPC available)
Maximum Dose
120 mg/m2 (max daily dose amount recorded 120 mg/m2)
Investigational Product Name
GEMCITABINE
Active Substance
Gemcitabine hydrochloride
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (SmPC available)
Maximum Dose
1200 mg/m2 (max daily dose amount recorded 1200 mg/m2)

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