Radium-223 dichloride long-term follow-up program
Research type
Research Study
Full title
A Phase 4 long-term follow-up study to define the safety profile of radium-223 dichloride
IRAS ID
259908
Contact name
Janet Brown
Contact email
Sponsor organisation
Bayer AG
Eudract number
2014-002407-25
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
Research Summary
The study purpose is to define the long-term safety profile of radium-223 dichloride. Patients who have participated in feeder trials using radium-223 dichloride will be eligible to participate in the study.
This study will be conducted at NHS sites. The study will take place for 7 years, with follow-up visits occurring every 6 months.
The study will assess if and how many patients develop leukemia (cancer of the blood), myelodysplastic syndrome (bone marrow disorder in which the bone marrow does not produce enough healthy blood cells), aplastic anaemia (condition that occurs when your body stops producing enough new blood cells), and primary bone cancer or any other new primary tumours.
As part of their separate standard care some patients will receive cytotoxic chemotherapy during the follow up, and for these patients it will be assessed how often they suffer from febrile neutropenia (fever and a significant reduction in white blood cells) or haemorrhage (abnormal bleeding) during their chemotherapy treatment and for up to 6 months thereafter at a frequency based on local clinical practice.
Summary of Results
Plain Language Summary is not currently available. It will be available by middle of January 2025.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
19/EE/0095
Date of REC Opinion
24 May 2019
REC opinion
Further Information Favourable Opinion