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Brief Title: Escalating Dose Study in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia
Official Title: 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's Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia
Study ID: NCT01351935
Brief Summary: The purpose of this study is to evaluate the safety and tolerability of AVL-292 as monotherapy in subjects with relapsed or refractory B cell non-Hodgkin lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or Waldenstrom's macroglobulinemia (WM).
Detailed Description: Bruton's tyrosine kinase (Btk) is non-receptor tyrosine kinase with restricted cellular expression largely limited to B-lymphocytes, monocytes, and mast cells or basophils. Btk is a critical component of the B cell receptor (BCR) signaling network and is crucial for B cell development. Investigation has revealed that some B cell lymphomas and CLL depend on BCR signaling, suggesting that interruption of such signaling could be a promising therapeutic opportunity in B-NHL, CLL and WM.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Clearview Cancer Institute Oncology Specialties, P.C, Huntsville, Alabama, United States
University of Arizona SPORE, Tucson, Arizona, United States
University of California San Diego, La Jolla, California, United States
Mayo Clinic Jacksonville, Jacksonville, Florida, United States
Northwestern University, Chicago, Illinois, United States
Horizon Oncology Center, Lafayette, Indiana, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Mount Sinai School of Medicine and Mount Sinai Graduate School of Biological Sciences, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Cleveland Clinic, Cleveland, Ohio, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
University of Texas Health Sciences Center, San Antonio, Texas, United States
US Oncology, The Woodlands, Texas, United States