Restarted Lymphoma Research Gives Patients The Chance To Dream Big
Since the announcement of the NIHR RESTART framework in May research teams across the UK have been working tirelessly to restart trials paused as a result of Covid-19. Dr David Tucker has been working with the team at Royal Cornwall Hospitals Trust and commercial sponsor Regeneron Pharmaceuticals to carefully balance the restart of clinical care and research so their patients can plan for a brighter future.
Bispecific Antibody Lymphoma Research
The trial of an investigational bio-engineered fully human monoclonal antibody is being tested in patients with relapsed lymphoma. The investigational drug, a Bispecific Antibody is designed to bring the patient’s own immune cells into direct contact with the lymphoma cells – allowing the immune system to destroy the tumour cells. The therapy is part of an international Phase II clinical trial of which RCHT is one of eight selected UK sites. The first patient to be recruited in the UK into this study received the therapy at RCHT this month.
Dr David Tucker, Consultant Haematologist and Research Lead for RCHT Haematology, is Principal Investigator on the study and said:
“It is really exciting that RCHT-Haematology is at the forefront of this research and we are very pleased to have been able to maintain our forward momentum in research at RCHT despite COVID-19. This state of the art therapy which harnesses the immune system against lymphoma cells is more selective than conventional chemotherapy and is particularly useful when tumours become more resistant to standard treatments. It may represent the future in the battle against some forms of cancer and I am very proud that the team has been able to continue to offer this to patients in a safe environment at RCHT throughout the COVID-19 pandemic.”
Making changes
Before the trial could get up and running again considerations and changes needed to be made to make the trial workable and safe to deliver. The team balanced the risks of COVID-19 against the benefits of our trial therapies in patients with unmet needs in lymphoma. A continuous Multi-Disciplinary Team dialogue and collaboration with ward-based staff was maintained to ensure patient safety and ward preparedness.
Careful risk assessment of visits with mitigation measures in place, such as PPE, social distancing and proactive swabbing prior to admission for procedures were put in place to ensure the trial could go ahead safely for patients and staff.
‘Given the chance’
A patient, who wanted to remain unnamed, described what the trial meant to her:
“If I hadn’t been given the chance to do this trial I would have nowhere else to go. I’d tried every type of chemo and was facing palliative care. I was absolutely elated [that I could partake in the trial] I would’ve been dead with just palliative care, that was the only [other] option.”
She continued to describe her motivation for partaking in the trial:
“I’ve got to do this, for me, because that’s the only option. My second thought was ‘oh my god, think about the people in my beloved Cornwall that could benefit from this’. This new autoimmune system therapy is going to be massive.”
The hope the trial has given her has allowed her to look to the future and make positive plans:
“I have one big goal, to enjoy my beloved Cornwall. This is going to give me time at Christmas to be able to be driven down to Newlyn and see all the Christmas lights up, that is my goal that I’m heading for! To sit in the car without any pain in my bottom, that’s where my cancer is, that’s what I’m aiming for a by hell I’m going to do it!”
She thanked Dr Tucker and the team for their efforts in difficult circumstances and described how the team’s attention to following Covid-19 guidelines made her ‘feel safe’ during her stay in hospital.
“I am elated that Treliske Hospital (Royal Cornwall Hospitals Trust) has been given this [trial]. I’m so elated because they’ve got so much of the equipment there already, but this has given them the chance to do that rather than people who are really so ill having to go all the way up to Derriford (Plymouth) or one of those hospitals even some have to go to Southampton. They’ll all be there in Treliske Hospital, how fantastic is that?”
Lessons from Covid-19
The team want to ensure everyone involved is well prepared before getting the trial up and running so educational sessions with the department, nursing staff on the ward and the ITU Team were set up to prepare for potential adverse events from this particular therapy (e.g. cytokine release syndrome). The team’s Specialist Registrar (SpR) Dr Challenor developed a flow chart and document on what to look out for and what to do if complications developed for the out of hours medical teams.
Setting up a research study will always present challenges and even more so with the considerations to manage the risks of Covid-19. The team at RCHT have shown how with the correct planning, mitigation measures and collaboration between staff and patients, such challenges to restarting research can be successfully overcome.
The trial is expected to last several years and RCHT Haematology hopes to enrol patients with different forms of lymphoma that have relapsed or refractory to conventional therapies.
Further reading:
https://clinicaltrials.gov/ct2/show/NCT03888105
https://investor.regeneron.com/static-files/26c7e457-fd7b-483b-a3fc-f651ade59077
