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

Status: Recruiting
Phase: Phase 1
Diagnosis: Non-Hodgkin's Lymphoma, Leukemia/MDS, Waldenstrom's Macroglobulinemia
NCT ID: NCT01351935 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-272

 

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).

 

Conducting Institutions:
Dana-Farber Cancer Institute, Massachusetts General Hospital, Brigham and Women's Hospital

Overall PI:
Jennifer Brown, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Jeffery Barnes, MD, Dana Farber Cancer Institute

Contacts:
Dana-Farber Cancer Institute: Kathleen McDermott, kmcdermott@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility 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
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