ASSURE

• Research type

  Research Study

• Full title

  A Phase 3b, Multicenter, Open-Label, Single-Arm Study of Acalabrutinib (ACP-196) in Subjects with Chronic Lymphocytic Leukemia

• IRAS ID

  262742

• Contact name

  Charlotte Pai

• Contact email

  charlotte.pai@parexel.com

• Eudract number

  2019-001573-89

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  5 years, 11 months, 31 days

• Research summary

  Chronic lymphocytic leukaemia (CLL) is the most frequent form of adult leukaemia (Leukaemia is a cancer which starts in blood-forming tissue, usually the bone marrow. It leads to the over-production of abnormal white blood cells, the part of the immune system which defends the body against infection).

  This study will enrol participants with treatment-naïve (never undergone treatment) or relapsed (disease that reappears or grows again after a period of remission)/refractory (does not respond to treatment) CLL.

  Current standard therapy for CLL is chemoimmunotherapy (Chemotherapy uses different drugs to kill or slow the growth of cancer cells; immunotherapy uses treatments to stimulate or restore the ability of the immune system to fight cancer).
  Despite the potential for prolonged progression-free survival (PFS= the length of time during and after the treatment of a disease, that a patient lives with the disease but it does not get worse) chemoimmunotherapy is associated with significant short and long-term toxicities.

  Sponsor AstraZeneca is developing a new anticancer agent Acalabrutinib which is a selective, irreversible small molecule inhibitor of Bruton tyrosine kinase (BTK= a gene that provides instructions for making a protein called Bruton tyrosine kinase (BTK), which is essential for the development and maturation of B cells. B cells are specialised white blood cells that help protect the body against infection).

  This is a study to evaluate the safety and tolerability of Acalabrutinib mono therapy in participants with treatment-naive (TN) or relapsed/refractory (R/R) chronic lymphocytic leukaemia (CLL).

  There will be approximately 600 participants taking part in this study at about 170 study centres globally.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  19/NW/0703

• Date of REC Opinion

  31 Jan 2020

• REC opinion

  Further Information Favourable Opinion