A Phase 3 Study Comparing Pirtobrutinib to Ibrutinib in CLL/SLL
Research type
Research Study
Full title
A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) versus Ibrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314)
IRAS ID
1005666
Contact name
Lars Holzhausen
Contact email
Sponsor organisation
Loxo Oncology, Inc.
Eudract number
2021-003206-41
Clinicaltrials.gov Identifier
Research summary
This research study is being done to test if an investigational (not approved) treatment called pirtobrutinib is better than an approved standard therapy called ibrutinib for treatment of Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma (CLL/SLL). It will test which treatment is safest and which treatment works best. These cancers are dependent on a protein made by the cancers called “ Bruton’s tyrosine kinase (BTK)”. Pirtobrutinib is a “BTK inhibitor” designed to block both normal and mutated forms of BTK in these cancers. It works in a different way to ibrutinib which blocks normal forms of BTK in these cancers.
A Participant in this study will receive either pirtobrutinib (Arm A) or ibrutinib (Arm B) in a 50:50 chance. Both Medications are taken by mouth, no infusions are needed. Ibrutinib is a treatment that has been shown to be safe and to work well for patients with CLL/SLL. All participants will have exactly the same investigations and procedures, treatment will be given over the same length of time and the follow-up period will be the same. It will then be compared to decide if pirtobrutinib works as well as ibrutinib and is safe to be used.
Sometimes these cancers can progress (worsen) without causing any symptoms or problems for a participant. If this happens in this study and the study doctor thinks it is safe and will benefit the participant, the study treatment can be continued.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
22/NW/0170
Date of REC Opinion
5 Jul 2022
REC opinion
Further Information Favourable Opinion