STATIC v1.0
Research type
Research Study
Full title
A Randomised Phase III Trial Comparing Intermittent with Continuous Treatment Strategies in Chronic Lymphocytic Leukaemia (CLL)
IRAS ID
1003615
Contact name
Louise Harris
Contact email
Sponsor organisation
University of Leeds
Eudract number
2021-005854-27
ISRCTN Number
ISRCTN51675454
Research summary
Ibrutinib is one of a group of drugs for chronic lymphocytic leukaemia (CLL) called targeted drugs. Targeted drugs, including ibrutinib, have fewer side effects than traditional chemotherapy. However, as the drug is usually taken for several years, these side effects can be a burden.
There is some evidence that, if ibrutinib is taken for several years, the CLL is more likely to become resistant to this treatment. STATIC will investigated whether having a break from ibrutinib treatment will work as well as continuing treatment without a break, if whether taking a break from ibrutinib reduces side effects, whether it lowers the risk of CLL becoming resistant to ibrutinib, and whether there is any difference in the overall cost of CLL treatment. We also want to know whether having a break from ibrutinib changes how patients are feeling emotionally.830 patients will be enrolled into the STATIC trial. These patients will be made up of patients who have been treated on the NHS with Ibrutinib as their second or subsequent treatment for their CLL as well as those who have been treated in another study called the FLAIR trial. Patients will be randomly allocated to have either continuous or intermittent treatment with ibrutinib.
The study will be run by the Clinical Trials Research Unit (CTRU) at the University of Leeds. The study will be conducted in 100 hospitals throughout the UK.
A small number of patients finishing FLAIR will be advised to continue ibrutinib as their CLL is not well controlled enough for them to take part in the randomised trial and they can continue ibrutinib treatment in STATIC without being randomised.
REC name
North East - York Research Ethics Committee
REC reference
22/NE/0097
Date of REC Opinion
3 Aug 2022
REC opinion
Further Information Favourable Opinion