BRUIN MCL-321

• Research type

  Research Study

• Full title

  A Phase 3 Open-Label, Randomized Study of LOXO-305 versus Investigator Choice of BTK Inhibitor in Patients with Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma (BRUIN MCL-321)

• IRAS ID

  294868

• Contact name

  L. Holzhausen

• Contact email

  lholzhausen@loxooncology.com

• Sponsor organisation

  Loxo Oncology, Inc

• Eudract number

  2020-004553-72

• Clinicaltrials.gov Identifier

  NCT04662255

• Duration of Study in the UK

  3 years, 1 months, 2 days

• Research summary

  This study is being done to test how well LOXO-305 works in treatment of BTK naive Mantle Cell lymphoma (MCL) and how safe it is. LOXO-305 is an investigational (experimental) drug that may treat certain cancers like leukaemia and lymphomas. These types of cancer are dependent on or “addicted to” a protein made by the cancers called “BTK”. LOXO-305 is a “BTK inhibitor” — it is designed to block both normal and mutated forms of BTK in these cancers. Other drugs used to treat this type of cancer are ibrutinib, acalabrutinib, and zanubrutinib which are approved by the US FDA and other health authorities around the world, including the MHRA in the UK. Participants will receive either LOXO-305 (Arm A) or the study doctor’s choice of ibrutinib, acalabrutinib, or zanubrutinib (Arm B).
  This study will be done in patients with MCL who have previously received treatment but have never used a BTK inhibitor.
  The purpose of this research study includes the following:
   To determine how long any benefits from treatment with LOXO-305 (Arm A) lasts compared to investigator’s choice of ibrutinib, acalabrutinib, or zanubrutinib (Arm B)
   To determine how well patients with MCL respond to treatment with LOXO-305 compared to investigator’s choice of ibrutinib, acalabrutinib, or zanubrutinib
   To determine how the safety of LOXO-305 compares to the safety of ibrutinib, acalabrutinib, and zanubrutinib
   To determine how well patients feel while taking LOXO-305 compared to ibrutinib, acalabrutinib, or zanubrutinib
  

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  21/ES/0033

• Date of REC Opinion

  29 Apr 2021

• REC opinion

  Further Information Favourable Opinion