A Phase I/II Study of LOXO-305 in Patients with Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma

Full Title

A Phase 1/2 Study of Oral LOXO-305 in Patients with Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL)

Purpose

The purpose of this study is to determine the highest dose of the investigational drug LOXO-305 that can be used safely in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) or non-Hodgkin lymphoma (NHL) that continues to grow despite treatment, and to determine its effectiveness in these patients.

The development of cancers such as leukemia and lymphoma depends in part on a protein made by cancer cells called Bruton’s tyrosine kinase (BTK). LOXO-305 is a type of drug called a BTK inhibitor; it blocks BTK in these cancers, including those that have been treated with other drugs (for example, ibrutinib or acalabrutinib) but have come back or continued to grow. LOXO-305 is taken orally (by mouth).

Eligibility

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

  • Patients must have CLL/SLL or NHL that has continued to grow despite at least two prior regimens of therapy.
  • Patients should recover from the serious side effects of prior therapies before entering the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Anthony Mato at 212-639-8596.

Protocol

19-077

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators