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


Jacksonville, Fla.

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

Inclusion Criteria: - Women and men ≥18 years of age - Body weight ≥50 kg. - Confirmed diagnosis of B cellNon-Hodgkin Lymphoma(according to World Health Organization [WHO] classification)including Chronic Lymphocytic Leukemia/Small cell Lymphocytic Leukemia (International Workshop),or Waldenstrom's Macroglobulinemia(Second International Workshop) - Have failed ≥1 previous treatment for B-NHL/CLL/WM, and have relapsed or refractory disease following last prior treatment. - Eastern Cooperative Oncology Group performance status of ≤ 2 and a life expectancy of at least 3 months. - Ability to swallow oral capsules without difficulty - Has recovered from adverse toxic effects of prior therapies - Meet the following clinical laboratory requirements: - Creatinine ≤ 1.5 × upper limit of normal (ULN) - Total bilirubin ≤ 1.5 x ULN - AST and ALT ≤ 3 × ULN - Platelet count ≥ 50,000/µL (non-hodgkin & Waldenstrom's) - Platelet count ≥ 30,000/µL (chronic lymphocytic leukemia) - Absolute Neutrophil count ≥ 1000/µL Exclusion Criteria: - Prior allogeneic bone marrow transplant - Autologous stem cell transplant within 3 months of screening - Active central nervous system involvement - Subjects with autoimmune hemolytic anemia or immune thrombocytopenia - Prior treatment with a Btk inhibitor - Active uncontrolled infection - History of malabsorption - Uncontrolled illness, i.e cardiac, endocrine, respiratory, etc. - History of myocardial infarction, acute coronary syndromes, coronary angioplasty and/or stenting with in the previous 6 months - History of another currently active cancer - History of major surgery within 4 weeks or minor surgery within 1 week - Other medical or psychiatric illness or organ dysfunction - HIV positive - Positive for Hepatitis B surface antigen or Hepatitis C-virus

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