TERZO
Research type
Research Study
Full 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 (TERZO)
IRAS ID
1010625
Contact name
Cathy Reddick
Contact email
Sponsor organisation
Secura Bio Limited
Clinicaltrials.gov Identifier
Research summary
Non-Hodgkin’s lymphoma is a type of blood cancer. Nodal T cell lymphoma (TCL) with T follicular helper (TFH) phenotype is a subtype of this cancer. If this cancer returns after a patient’s previous treatment (relapsed disease) or does not respond to treatment (refractory disease), treatment options include the anti-cancer drugs gemcitabine or bendamustine. Secura Bio, the sponsor of this study, is developing a new drug, called duvelisib, for treating nodal TCL with TFH phenotype. Duvelisib has shown potential to slow the progression of blood cancer. This study will test how effective and safe duvelisib (the experimental drug) is for treating relapsed/refractory nodal TCL with TFH phenotype by comparing it to treatment with either gemcitabine or bendamustine (comparator drugs).
The study will be conducted in UK (England and Scotland) and in different countries in the European Union.
Patients are expected to stay in the study for 24 months but that will depend on response to the study drug and how well it is tolerated. This study will enroll adult patients with confirmed relapsed/refractory nodal TCL with TFH phenotype who have had at least 1 prior anti-cancer therapy.
Study procedures include imaging scans to see if the cancer improves or worsens (every 8 weeks for duvelisib and gemcitabine; every 6 weeks for bendamustine), as well as questionnaires, blood tests, physical examinations, vital signs measurements, and electrocardiograms. Patients will use diaries to track duvelisib treatment. Unwanted side effects and use of other medicines will be recorded throughout the study. Additional procedures might be done during some study visits and could include extra blood samples or bone marrow testing.
A follow-up visit will take place about 30 days from last dose of study drug and before the patient begins any other anti-cancer therapy, a long-term Follow-up period may last up to 3 years depending on the response to treatment.REC name
East Midlands - Derby Research Ethics Committee
REC reference
25/EM/0060
Date of REC Opinion
24 Jan 2025
REC opinion
Further Information Favourable Opinion