A Phase 3 Study Comparing LOXO-305 to Bendamustine plus Rituximab in Untreated Patients
Research type
Research Study
Full title
A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) versus Bendamustine plus Rituximab in Untreated Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-313)
IRAS ID
1004084
Contact name
Lars Holzhausen
Contact email
Sponsor organisation
Loxo Oncology Inc
Eudract number
2021-001234-20
Clinicaltrials.gov Identifier
Research summary
Chronic Lymphocytic Leukaemia (CLL) / Small Lymphocytic Lymphoma (SLL) are very common forms of leukaemia. These cancers are dependent on or “addicted to” a protein made by the cancers called Bruton’s Tyrosine Kinase (BTK). Other drugs used to treat this type of cancer include bendamustine, fludarabine, cyclophosphamide, venetoclax and rituximab, which are approved by health authorities around the world. These drugs have demonstrated improvement in control of CLL/SLL and extended participants’ survival.
This clinical trial is being done to test the safety and efficacy (how well it works) of investigational drug pirtobrutinib (LOXO-305). Pirtobrutinib is a BTK inhibitor designed to block both normal and mutated forms of BTK in these cancers. This trial is designed to look at whether patients might benefit from being treated with a new investigation study drug, LOXO-305, rather than the alternative standards of care – in this case the comparator is the combination of bendamustine and rituximab.
It is expected that approximately 250 untreated adults CLL/ SLL will take part in this research study in about 175 centres around the world.
The study is planned to last for about 4 years. The screening period will last up to 28 days. If enrolled, patients will then be randomised 1:1 to receive either LOXO-305 (Arm A) or bendamustine plus rituximab (Arm B). Patients randomised to Arm A will receive LOXO-305 orally until discontinuation criteria are met including but not limited to progressive disease, unacceptable toxicity, investigator intervention, withdrawal of consent (full criteria is defined in the study protocol). Patients randomised to Arm B will receive up to six cycles of bendamustine and rituximab intravenously until they experience unacceptable toxicity or improvement, death, lost-to-follow-up, withdrawal of consent or study completion. Treatment crossover, from Arm B to Arm A, is possible in the event of progressive disease.
REC name
London - Fulham Research Ethics Committee
REC reference
21/LO/0832
Date of REC Opinion
26 Jan 2022
REC opinion
Further Information Favourable Opinion