Dose finding study of Betalutin® for relapsed DLBCL
Research type
Research Study
Full title
A Phase 1 Dose finding study of lutetium (177Lu)-lilotomab satetraxetan (Betalutin®) in patients with relapsed/refractory, diffuse large B-cell lymphoma, not eligible for autologous stem cell transplant
IRAS ID
199642
Contact name
Timothy Illidge
Contact email
Sponsor organisation
Nordic Nanovector ASA
Eudract number
2015-001933-26
Duration of Study in the UK
3 years, 1 months, 30 days
Research summary
Summary of Research
Diffuse large B-cell lymphoma (DLBCL) is a fast-growing blood cancer that either does not respond to treatment or returns in about 30% of patients. These refractory or relapsed patients do not have effective therapeutic options with a median untreated survival of approximately 6 months. Therefore, new types of treatment are needed. Radioimmunotherapy is an effective treatment for other types of lymphoma. It utilises antibodies with a radioisotope attached to deliver radiation to cancer cells. Betalutin is a new radioimmunotherapy drug, in which the radioisotope Lutetium-177 is attached to the antibody HH1.
The purpose of this study is to establish the maximum tolerated dose of Betalutin, to investigate how safe it is, the biodistribution of the drug and to gain some insight into its effectiveness.
Around 18 DLBCL patients who have received at least one prior treatment and have relapsed at least 6 months after their initial therapy and who are not eligible for stem cell transplantation will participate in this phase 1 dose escalation study.
Patients will receive a dose of Rituximab and two weeks later an infusion of HH1 to help Betalutin reach less accessible cancerous cells and to reduce the side effects of Betalutin, followed by a Betalutin injection within 4 hours of HH1.
After the injection the patients will be followed up weekly for 12 weeks, then every month until month 6, then every 3 months until month 24.
Assessments for this study include physical examinations, ECG, blood and urine samples, CT/PET scans, tumour and bone marrow biopsy. At least six patients will participate in the dosimetry part of the study. They will have additional follow-up visits on days 1-4, provide extra samples and undergo SPECT/CT scans.
Approximately 10 centres will participate in the study including 2 in the UK.Summary of Results
This study started in February 2017 and ended in June 2021.
REC name
West of Scotland REC 1
REC reference
16/WS/0045
Date of REC Opinion
11 Apr 2016
REC opinion
Further Information Favourable Opinion