REMIT
Research type
Research Study
Full title
RadiotheRapy priMIng for CAR-T
IRAS ID
295832
Contact name
Andrea Kuhnl
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This trial is testing bridging radiotherapy prior to tisagenlecleucel chimeric antigen receptor T-cell therapy (CAR-T) for patients with aggressive non-Hodgkin lymphoma (diffuse large B-cell lymphoma) which has not responded to prior treatment or has relapsed. CAR T-cells are manufactured from patient’s own white blood cells, a process which takes around six weeks. Treatments used to control and reduce lymphoma during this period are called bridging therapies. Effective bridging allows patients to remain well enough to proceed to CAR T-cell therapy and may lead to improved responses and fewer serious side effects. This trial will assess whether it is possible to give bridging radiotherapy, planned and given according to the amount of lymphoma in different parts of the body (known as the metabolic tumour volume, assessed on a PET scan), without delaying the CAR T-cell treatment.
Radiotherapy is already used as bridging therapy, but no standard protocols exist, and it has not been assessed in a clinical trial. In this trial a higher dose of radiotherapy will be given to larger areas of lymphoma with potential to cause symptoms, and a lower dose to smaller areas of lymphoma. The total radiotherapy dose will be equivalent to doses used in standard practice. This aims to give the best reduction in the lymphoma volume before CAR T-cell therapy, and it is also thought that the effect of radiotherapy on the treated areas and on the immune system may improve how well the CAR T-cell therapy works.
Radiotherapy will be given 5 days per week and the duration will depend on the individual treatment plan. There will be a minimum gap of 14 days after radiotherapy before CAR-T cell therapy. All subsequent care will be given according to standard practice in the treating hospital and there should be no change in the overall duration of lymphoma treatment.
REC name
London - Surrey Research Ethics Committee
REC reference
21/LO/0714
Date of REC Opinion
15 Oct 2021
REC opinion
Favourable Opinion