A Randomised Phase III Trial Comparing Intermittent with Continuous Treatment Strategies in Chronic Lymphocytic Leukaemia (CLL)

Research summary

STATIC is designed with multiple pathways, the ‘Randomisation Pathway’ and the ‘Clinical Need Cohort’, which route a participant enters will be determined by their eligibility. Randomisation Trial: A prospective, national, multicentre, open-label, randomised, controlled, 2-arm, parallel-group, non-inferiority ,phase III trial to assess whether patients with CLL on long-term treatment with a BTK inhibitor, (including ibrutinib) have similar disease control with an intermittent treatment strategy (experimental arm) compared with standard continuous treatment (control arm). Patients who have received ibrutinib in the NHS after receiving at least one previous treatment and patients who have received ibrutinib as their first treatment as part of the FLAIR trial can enter the randomisation trial. Clinical Need Cohort: A prospective, national, multicentre, open-label, single-arm, non-randomised cohort to assess the safety and overall survival of patients with CLL receiving long-term continuous treatment with ibrutinib. Patients who have received ibrutinib as their first treatment as part of the FLAIR trial may be able to join the clinical need cohort. The primary aim is to assess whether patients with CLL on long-term treatment with BTK inhibitor (including ibrutinib) have similar disease control with an intermittent treatment strategy, known as the ‘Pausing Ibrutinib’ arm compared with standard continuous treatment, the ‘Continuous Ibrutinib’ arm. The primary objective is to assess non-inferiority (NI) of the intermittent treatment strategy in terms of time to treatment strategy failure, defined as the first documented instance of active disease (as defined by the 2018 iwCLL criteria) that does not respond to treatment or death.

Principal Investigator

Dr Toby Eyre

Contact us

Email: Latephasehaematology@ouh.nhs.uk

IRAS number

1003615