A Phase III Study of Venetoclax and Rituximab with and without Pirtobrutinib for Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

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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) (WIRB)

Purpose

The purpose of this study is to compare the effectiveness of treatment with the investigational drug pirtobrutinib added to standard venetoclax and rituximab therapy versus the standard therapy alone in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that continues to progress despite treatment. Participants will be randomly assigned to receive venetoclax and rituximab with or without pirtobrutinib.

CLL and SLL are “addicted” to a protein called BTK. Pirtobrutinib is designed to block both normal and mutated forms of BTK in these cancers, including cancers that have continued to grow despite other BTK inhibitors (such as ibrutinib or acalabrutinib). Pirtobrutinib and venetoclax are taken orally (by mouth) and rituximab is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Participants must have CLL or SLL that continues to progress despite treatment.
  • All serious side effects of prior therapies must 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 about this study and to inquire about eligibility, please contact Dr. Anthony Mato at 646-608-3748.

Protocol

21-375

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators