A Study of Duvelisib Versus the Anti-cancer Drugs Gemcitabine or Bendamustine in Patients With T Cell lymphoma (a type of blood cancer), which originated from a certain type of T cells Called T Follicular Helper (TFH) cells (Nodal T Cell Lymphoma with T Follicular Helper [TFH] phenotype), that has returned (relapsed) or that is resistant to other treatments (refractory)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Secura Bio Limited

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

12 May 2025 → ongoing

Decision date (initial)

2025-07-16

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Secura Bio Limited

External identifiers

EU CT number

2024-516605-23-00

ClinicalTrials.gov

NCT06522737

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

To evaluate the Independent Review Committee (IRC)-determined progression-free survival (PFS) benefit of duvelisib monotherapy as compared to investigator’s choice of gemcitabine or bendamustine

Secondary objectives 5

1. To evaluate the overall survival (OS) benefit of duvelisib monotherapy as compared to gemcitabine or bendamustine
2. To evaluate additional efficacy parameters (Investigator-assessed PFS, objective response rate [ORR], complete response rate [CRR], duration of response [DOR], proportion of patients who proceed to stem cell transplantation [SCT], PFS in patients who proceed to SCT) achieved with duvelisib monotherapy as compared to gemcitabine or bendamustine
3. To evaluate the safety of duvelisib monotherapy as compared to gemcitabine or bendamustine
4. To evaluate the impact of duvelisib monotherapy on quality of life (QoL) as compared to gemcitabine or bendamustine
5. To evaluate pharmacokinetics of duvelisib in patients who have nodal T cell lymphoma with TFH phenotype

Conditions and MedDRA coding

relapsed/refractory nodal T cell lymphoma with T follicular helper (TFH) phenotype

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Swedish Medical Products Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 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.
2. Relapsed or refractory to at least 1 prior systemic, cytotoxic therapy for T cell lymphoma.
3. Measurable disease as defined by Lugano 2014 criteria (Cheson 2014) for T cell lymphoma
4. ECOG Performance Status 0, 1 or 2
5. For women of childbearing potential (WOCBP): negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test within 3 days before first treatment
6. 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 6

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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

Secondary endpoints 12

1. Overall Survival (OS) - Up to 3 years
2. PFS as assessed by the investigator - Up to 3 years
3. Objective Response Rate (ORR) as assessed by the IRC - Up to 3 years
4. Complete Response Rate (CRR) as assessed by the IRC - Up to 3 years
5. Duration of Response (DOR) as assessed by the IRC - Up to 3 years
6. Proportion of participants who proceed to Stem Cell Transplantation (SCT) - Up to 3 years
7. Investigator-assessed PFS in participants who proceed to SCT - Up to 3 years
8. Incidence/frequency of Adverse Events (AEs) and abnormal laboratory values - Up to 3 years
9. Quality of Life (QoL): European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Score - Up to 3 years
10. QoL: EQ5D Score - Up to 3 years
11. QoL: QLQ-NHL-HG29 Score - Up to 3 years
12. PK parameters derived from blood concentrations of duvelisib and its metabolites

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Secura Bio Limited

Sponsor organisation

Secura Bio Limited

Address

32 Molesworth Street

City

Dublin 2

Postcode

D02 Y512

Country

Ireland

Scientific contact point

Organisation

Secura Bio Limited

Contact name

Head of Clinical Development

Public contact point

Organisation

Secura Bio Limited

Contact name

Head of Clinical Development

Third parties 9

Locations

9 EU/EEA countries · 39 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 115 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

14 submissions — initial application plus substantial / non-substantial modifications