A Phase III Study of LOXO-305 versus a Standard BTK Inhibitor in Patients with Mantle Cell Lymphoma

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Full Title

A Phase 3 Open-Label, Randomized Study of LOXO-305 versus Investigator Choice of BTK Inhibitor in Patients with Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma (BRUIN MCL-321)

Purpose

The purpose of this study is to compare the effectiveness of the investigational drug LOXO-305 (pirtobrutinib) with standard therapy using a drug called a BTK inhibitor in people with mantle cell lymphoma (MCL) who have not yet received a BTK inhibitor. BTK is a protein that promotes the growth of some lymphomas, including MCL. Examples of currently used BTK inhibitors include ibrutinib, acalabrutinib, and zanubrutinib.

LOXO-305 is a new type of BTK inhibitor. Patients will be randomly assigned to receive LOXO-305 versus a standard BTK inhibitor (ibrutinib, acalabrutinib, or zanubrutinib). These medications are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have MCL that continues to grow despite prior treatment.
  • Patients should recover from the serious side effects of previous treatments before receiving the study therapy.
  • 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 ask about eligibility, please contact the office of Dr. Anita Kumar at 646-608-3780.

Protocol

21-360

Phase

III

Investigator

Gilles Salles