ActiveCancerNIHR-supported projectDigestion, Kidneys & Other Organs
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)
Recipient organisationNIHR University College London Hospitals Biomedical Research Centre
NIHR supportRecorded as supported by this research centre
PeriodFeb 2025 — Jul 2027
In plain English
AI plain-English summary
A new drug, duvelisib, is being tested against standard chemotherapy in a phase 3 trial for patients with a rare and aggressive form of blood cancer that has stopped responding to treatment. This matters because nodal T cell lymphoma with T follicular helper (TFH) phenotype often returns or resists initial therapy, and the existing options—gemcitabine or bendamustine—offer limited benefit. No targeted therapy is currently approved for this specific subtype. Duvelisib, which blocks enzymes that fuel cancer cell growth, has shown early promise in slowing blood cancer progression. If duvelisib proves more effective and safer than current chemotherapy, it could become the first targeted treatment approved for relapsed or refractory nodal TCL with TFH phenotype. That would give patients a new option where few exist, potentially extending survival and improving quality of life by avoiding the harsh side effects of standard drugs. The trial runs across the UK and EU, enrolling adults who have already tried at least one prior therapy. Patients are monitored for up to three years, with regular scans and safety checks.
View original technical description
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.
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