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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Ms
Rhiannon
Lambkin
+44 (0)1133432813
STATIC@leeds.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Chronic lymphocytic leukaemia (CLL)
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Background and study aims
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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
Trial Registration Exclusion Criteria:1. Pregnant females2. Known intolerance or hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.3. Receipt of live vaccination within 4 weeks prior to registration and for the duration of the study.4. History or current evidence of Richter’s transformation5. Major surgery within 4 weeks prior to randomisation/or registration for the Clinical Need Cohort6. Active infection7. Concomitant warfarin (or equivalent vitamin K inhibitor)8. Central nervous system involvement with CLL9. Cardiac failure; including symptomatic cardiac failure not controlled by therapy,or unstable angina not adequately controlled by current therapy (in patients with a significant cardiac history the left ventricular function should be assessed and patients with severe impairment should be excluded)10. Respiratory impairment (e.g. bronchiectasis or severe COPD)11. Other severe, concurrent diseases or mental disorders that could interfere with their ability to participate in the study12. Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status),aHB DNA test will be performed and if positive the patients will be excluded. During treatment, these participants should be monitored and managed to prevent HBV reactivation.13. Positive serology for Hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a test for hepatitis C RNA (for example HCV RNA PCR). If positive the patients will be excluded.14. Persisting severe pancytopenia (neutrophils <0.5 x 109/L or platelets <50 x 109/L)unless due to direct marrow infiltration by CLL15. Current treatment with prednisolone of >20mg/day16. Uncontrolled Active haemolysis17. History of stroke or intracranial haemorrhage within 6 months prior to enrolment.18. Requirement for treatment with a strong CYP3A inhibitor or inducer 19. New treatment with two or more antiplatelet drugs, treatment that has been administered at a stable dose for at least 3 months prior to registration is permissible20. Current treatment with any concomitant ACE inhibitors
Additional exclusion criteria for participants in the Clinical Need Cohort:1. Meet none of the registration exclusion criteria2. Active Disease, as per the 2018 iwCLL criteria requiring an alternative therapy.3. Received treatment other than ibrutinib for CLL since completing FLAIR4. Be eligible for front-line randomisation5. Ibrutinib treatment break for toxicity/patient choice for more than 28 days in the last 12 months (added 07/11/2024)
Additional exclusion criteria for Front-Line participants entering the randomisation trial:1. Meet none of the registration exclusion criteria2. Disease progression (according to 2018 iwCLL criteria)3. Ibrutinib treatment break for toxicity/patient choice for more than 28 days in last 12 months
Additional exclusion criteria for Previously Treated participants entering the randomisation trial:1. Meet none of the registration exclusion criteria2. Disease progression (according to 2018 iwCLL criteria)3. Ibrutinib treatment break for toxicity/patient choice for more than 28 days in last 12 months4. Any illness,disease or condition,such as active cancer or secondary primary malignancy (SPM),with a prognosis of less than 5 years5. Patients with a creatinine clearance of less than 30ml/min (either measured or derived by the Cockcroft Gault formula or alternative locally approved formula).
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Ms
Rhiannon
Lambkin
+44 (0)1133432813
STATIC@leeds.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Leeds and funded by Health Technology Assessment Programme; Janssen-Cilag Limited; National Institute for Health Research.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 52879
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
