Full TitleA 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) (WIRB)
The purpose of this study is to compare the effectiveness of the drug LOXO-305 (pirtobrutinib) with standard therapy in people with persistent chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). LOXO-305 is a new type of BTK inhibitor. It blocks the BTK protein, which fuels the growth of some lymphomas.
Patients will be randomly assigned to receive LOXO-305 or a standard CLL/SLL treatment (either idelalisib plus rituximab or bendamustine plus rituximab). LOXO-305 and idelalisib are taken orally (by mouth) and rituximab and bendamustine are given intravenously (by vein).
To be eligible for this study, patients must meet several requirements, including:
- Participants must have CLL or SLL that needs to be treated
- Patients must have previously been treated with a BTK inhibitor.
- The serious side effects of previous therapies should resolve before receiving the study treatment.
- Patients must be able to walk and do routine activities for more than half of their normal waking hours.
- This study is for people age 18 and older.
For more information and to ask about eligibility for this study, please contact the office of Dr. Lindsey Roeker at 646-608-4115.