Phase 1b, Escalating Dose Study of AVL-292, a Bruton's Tyrosine Kinase (Btk) Inhibitor, as Monotherapy in Subjects with Relapsed and/or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia
ID Number 11-1128Principal Investigator(s)
Janice L. Gabrilove
Department(s) or Division(s)
Hematology and Medical Oncology
The purpose of this study is to determine the side effects of the study drug (named AVL-292) and the recommended dose for future studies. AVL-292 is a new drug designed to inhibit the function of an enzyme (a key chemical in the body) known as “Bruton’s tyrosine kinase.” The enzyme Bruton’s tyrosine kinase is important to the function of certain blood cells known as “B lymphocytes” or “B cells”. These B cells are part of your immune system and are the key abnormal cells in non-Hodgkin lymphoma, chronic lymphocytic leukemia, and Waldenstrom’s Macroglobulinemia; by blocking the function of this enzyme, your tumor may or may not improve (shrink or possibly disappear). We will test pharmacokinetics (PK) (how your body processes the study drug) and pharmacodynamics (PD) (how your condition responds to the study drug). We will also try to determine the recommended dose and determine if AVL-292 helps to improve your disease. This new drug has not been approved by FDA. This research study intends to determine the maximum dose of the study drug that your body will tolerate and also determine if this drug will improve your disease.
You may qualify to take part in this research study because you have B Cell Non-Hodgkin Lymphoma (B-NHL), Chronic Lymphocytic Leukemia (CLL) or Waldenstrom’s Macroglobulinema (WM) and you have already been treated with at least one prior medication.
Recruiting Patients: Yes