BRUIN CLL-321

• Research type

  Research Study

• Full title

  A Phase 3 Open-Label, Randomized Study of LOXO-305 versus Investigator’s Choice of Idelalisib plus Rituximab or Bendamustine plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321)

• IRAS ID

  295010

• Contact name

  George Follows

• Contact email

  g.follows@nhs.net

• Sponsor organisation

  Loxo Oncology, Inc.

• Eudract number

  2020-004554-30

• Clinicaltrials.gov Identifier

  NCT04666038

• Duration of Study in the UK

  3 years, 0 months, 6 days

• Research summary

  The study is being done to test the safety and efficacy (how well it works) of an investigational treatment called LOXO-305 versus approved standard therapies (investigators choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR)). LOXO-305 is an investigational (or experimental) drug that may treat Chronic Lymphocytic Leukaemia /Small Lymphocytic Lymphoma (CLL/SLL).
  The purpose of this research study includes the following:
  • To determine how well CLL/SLL patients respond to treatment with LOXO-305 (Arm A) compared to IdelaR or BR (Arm B)
  • To determine how long any benefits (including how long patients live) from treatment with LOXO-305, IdelaR, or BR lasts
  • To determine the safety of LOXO-305, IdelaR, and BR
  • To determine how well patients feel on LOXO-305 compared to IdelaR or BR

  The study will be carried out for at least 7 cycles and will continue till Progression. And patients will be 1:1 randomly assigned to either one or the other arm
  

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  21/NW/0061

• Date of REC Opinion

  16 Apr 2021

• REC opinion

  Further Information Favourable Opinion