A global trial has opened for children who have not responded to treatment for B-cell Non-Hodgkin Lymphoma (B-NHL), or who have relapsed.
Glo-BNHL, a global clinical trial run by the University of Birmingham and supported by PHTA, is now open in the UK, trialling multiple new treatments to offer a better chance of survival to hundreds of young people across the world over the next few years. The first sites have opened in the UK, and Glo-BNHL will open at 45 sites across 19 countries in Europe, Asia, North America and Australia.
Clinical trials traditionally compare one new treatment to the standard treatment used by doctors today. In the case of B-NHL that has not been cured (refractory) or has come back (relapsed), there are no adequate treatments anywhere in the world and most children will sadly die from the disease.
In the Glo-BNHL trial, several new drugs will be tested at the same time, meaning that there should always be at least one new drug for any child with relapsed or refractory B-NHL. Advanced statistical methods will be used to decide if a treatment is working or not with a very small number of patients, very quickly.
A treatment that is not working will be identified early and removed, to be replaced with another treatment. For treatments that do work, researchers believe there will be enough evidence to show regulators that the treatment should be adopted as standard care in the NHS and beyond. In this way, the usual lengthy process of trial and regulatory approval will be shortened significantly.
Professor Amos Burke, Director of the Cancer Research UK Clinical Trials Unit at the University of Birmingham and Chief Investigator of the Glo-BNHL trial said:
“Launching the first sites for Glo-BNHL is a hugely important moment and a step change for children with rare disease like relapsed/refractory B-NHL. This trial uses a new design, developed with ongoing input from our patient advocates. The design has been supported by regulators and pharma companies and the result is a trial that offers the possibility of better chances for children with relapsed or refractory B-NHL.”
Glo-BNHL will also be supported by the PHTA, driving the trial’s novel approach of an academic clinical trials unit delivering fit-for-filing trials. This will ensure that the trial is designed and delivered with market authorisation in mind, providing a more rapid pathway to clinical adoption at the end of the study.
The idea for Glo-BNHL came from discussions between academics, regulators, patient advocates and drug companies at the 2nd Paediatric Strategy forum of the ACCELERATE platform.
Nicole Scobie is President of children’s cancer charity Zoe4Life and is also a patient advocate involved in ACCELERATE and now also Glo-BNHL. Nicole set up Zoe4Life with Natalie Guignard-Nardin, mum of 4-year old Zoe who died after her cancer relapsed a year after receiving initial treatment. Zoe4Life supports children with cancer, their families and research into childhood cancer.
Nicole said: “I am delighted to have been able to support the development of the Glo-BNHL trial. Myself and other patient groups and members of the public very much hope that this trial and others that follow in its footsteps can address these significant unmet needs, particularly across paediatric cancer.
“We are all incredibly grateful to take part in the ACCELERATE meeting that led to the Glo-BNHL trial being established and that regulators and industry are acting on the experience and recommendations being made.”
Glo-BNHL gratefully receives funding from Cancer Research UK and Fight Kids Cancer. The drug companies working with Glo-BNHL have committed over £20 million of funding so far.
