Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom's Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing

Exclusion Criteria

• •Prior systemic therapy for WM
• •Any serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness/social condition that would prevent the participant from signing the informed consent form.
• •Concurrent use of any other anti-cancer treatments or any other investigational agents.
• •Concomitant use of warfarin or other Vitamin K antagonists.
• •Concomitant treatment with strong CYP3A4/5 inhibitor.
• •Any condition, including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
• •Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion could interfere with the absorption or metabolism of ibrutinib.
• •Known Central nervous system (CNS) lymphoma.
• •Concomitant use of medication known to cause QT prolongation.
• •Currently active, clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification, or history of myocardial infarction, unstable angina or acute coronary syndrome within 6 months of screening.
• •Malabsorption, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
• •Known history of Human Immunodeficiency Virus (HIV), active infection with Hepatitis B Virus (HBV), and/or Hepatitis C Virus (HCV). Subjects who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded.
• •Lactating or pregnant women.
• •Inability to swallow capsules.
• •History of non-compliance to medical regimens.
• •Unwilling or unable to comply with the protocol.
• •Major surgery within 4 weeks of first dose of study drug.
• •No active infections requiring systemic therapy.
• •Known bleeding disorders with the exception of acquired Von Willebrand Disorder suspected on the basis of WM.
• •History of stroke or intracranial hemorrhage within 6 months prior to enrollment.