A Phase III Study of LOXO-305 versus Standard Treatment for Persistent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

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Full Title

A 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)

Purpose

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).

Eligibility

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.

 

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Lindsey Roeker at 646-608-4115.

Protocol

21-504

Phase

III

Investigator

Co-Investigators