Escalating Dose Study in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia

• Status: Completed
• Trial end date: 2015-06-26
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Collaborator: The Leukemia and Lymphoma Society

Criteria

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