BRUIN-CLL-322 (LOXO-BTK-20022)
Research type
Research Study
Full title
A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) plus Venetoclax and Rituximab versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-322)
IRAS ID
296360
Contact name
Toby Eyre
Contact email
Sponsor organisation
Loxo Oncology Inc
Eudract number
2021-000043-49
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This research study is being done to test the safety and efficacy (how well it works) of an investigational treatment called pirtobrutinib (LOXO-305) plus venetoclax and rituximab (PVR) versus venetoclax and rituximab (VR). Pirtobrutinib is an investigational (or experimental) drug that may treat Chronic Lymphocytic Leukaemia /Small Lymphocytic Lymphoma (CLL/SLL).
These cancers are dependent on or “addicted to” a protein made by the cancers called “BTK”. Pirtobrutinib is a “BTK inhibitor” designed to block both normal and mutated forms of BTK in these cancers, including cancers against which available BTK inhibitors (e.g., ibrutinib or acalabrutinib) have stopped working or have side effects that make it difficult to continue treatment.
Other drugs, which may or may not include BTK inhibitors, used to treat this type of cancer in patients who have progressed or stop early due to side effects include idelalisib, bendamustine, duvelisib, venetoclax and rituximab. These are drugs which are approved by the US FDA and other health authorities around the world. The standard of care treatment option provided in this study is the combination of venetoclax and rituximab. If a patient will take part in this study, they will receive either pirtobrutinib plus venetoclax, and rituximab (Arm A) or venetoclax plus rituximab (Arm B) in a 50:50 chance. Venetoclax and rituximab is a therapy that has shown to be safe and effective for patients with CLL/SLL who have progressed or did not respond to prior treatment. The doctor and Participants will know what medication the participants will receive. Within the study there will Sponsor Monitoring Committees review collected data, collected in site provided safety and response information collected from each participants within the study.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
21/EM/0185
Date of REC Opinion
11 Nov 2021
REC opinion
Further Information Favourable Opinion