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 investigational 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.

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