Dose and efficacy study of Betalutin® for relapsed follicular lymphoma
Research type
Research Study
Full title
A Phase 2 study of the antibody-radionuclide-conjugate 177Lu-DOTA-HH1 (Betalutin®) in patients with CD37-positive relapsed follicular lymphoma
IRAS ID
184725
Contact name
Timothy Illidge
Contact email
Sponsor organisation
Nordic Nanovector ASA
Eudract number
2015-001570-17
Duration of Study in the UK
6 years, 2 months, 31 days
Research summary
Follicular lymphoma is a type of slow-growing blood cancer involving B-lymphocytes that can be treated effectively with chemotherapy and immunotherapy, however, relapses often occur and therefore there is a need for new types of treatment. In many cases radioimmunotherapy is effective. It uses antibodies with a radioisotope attached to deliver a dose of radiation to the cancer cells to destroy them. The purpose of this study is to test Betalutin, a new type of radioimmunotherapy, in which the radioisotope Lutetium-177 is attached to the antibody HH1. Betalutin binds to both cancerous and normal B-lymphocytes. The numbers of both are expected to fall following the treatment. This may increase the risk of infections but the number of B-lymphocytes is expected to recover within 12 months. Rituximab, an established immunotherapy, is used as a pre-treatment in the study to clear circulating normal B-lymphocytes to give Betalutin a better chance to bind to hard-to-reach cancerous cells.
The study will enrol adult patients with follicular lymphoma who have relapsed following at least 2 prior systemic treatments. This open-label study consists of two parts. Part 1 is designed to establish the optimal Betalutin treatment regimen in terms of effectiveness and safety. 45 patients will be equally randomised into 3 treatment arms. In Part 2, an additional 80 patients will receive the optimal treatment regimen established in part 1 to assess its effectiveness. The patients will undergo screening procedures to confirm if they can take part. Eligible patients will be pre-treated with 2 doses of Rituximab, and dependant on which arm they are randomised to, an infusion of HH1 followed by a single dose of Betalutin. After the Betalutin injection the patients will be followed up weekly for 12 weeks, then every 3 months until month 12, then every 6 months for a further 4 years. Assessments for this study include physical examinations, ECG, blood and urine samples, CT/PET scans, tumour and bone marrow biopsy. The study will be run at approximately 80 centres worldwide.
REC name
West of Scotland REC 1
REC reference
15/WS/0154
Date of REC Opinion
16 Sep 2015
REC opinion
Further Information Favourable Opinion