Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia
Condition: B-cell Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Diffuse Well-differentiated Lymphocytic Lymphoma; B Cell Lymphoma; Follicular Lymphoma; Mantle Cell Lymphoma; Non-Hodgkin's Lymphoma; Waldenstrom Macroglobulinemia; Burkitt Lymphoma; B-Cell Diffuse Lymphoma
MeSH terms: Burkitt Lymphoma; Lymphoma; Leukemia; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Mantle-Cell; Waldenstrom Macroglobulinemia
Intervention: PCI-32765
Intervention description: Dose based on parent protocol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 199.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PCI-32765; Lymphoma, B-Cell; Leukemia, Lymphoid; Leukemia, B-Cell; Bruton's Tyrosine Kinase

Summary:

      The purpose of this study is to determine the long-term safety of a fixed-dose, daily regimen
      of PCI-32765 PO in subjects with B cell lymphoma or chronic lymphocytic leukemia/small
      lymphocytic leukemia (CLL/SLL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women with recurrent surface immunoglobulin positive B cell non-Hodgkin's
             lymphoma (NHL) according to WHO classification (including, but not limited to,
             CLL/SLL, Waldenström's macroglobulinemia [WM], mantle cell lymphoma [MCL], and diffuse
             large B cell lymphoma [DLBCL) who have met requirements for roll over from their
             parent protocol and want to continue study drug.

          -  Female subjects of childbearing potential must have a negative serum or urine
             pregnancy test within 3 days of the first dose of study drug and agree to use dual
             methods of contraception during the study and for 1 month following the last dose with
             study drug. Post menopausal females (>45 years old and without menses for >1 year) and
             surgically sterilized females are exempt from this criterion.

          -  Male subjects must use an effective barrier method of contraception during the study
             and for 3 months following the last dose if sexually active with a female of
             childbearing potential.

          -  Willing and able to participate in all required evaluations and procedures in this
             study protocol including swallowing capsules without difficulty

          -  Ability to understand the purpose and risks of the study and provide signed and dated
             informed consent and authorization to use protected health information (in accordance
             with national and local patient privacy regulations).

        Exclusion Criteria:

          -  A life-threatening illness, medical condition or organ system dysfunction which, in
             the investigator's opinion, could compromise the subject's safety, interfere with the
             absorption or metabolism of PCI-32765 PO, or put the study outcomes at undue risk

          -  Known history of Human Immunodeficiency Virus (HIV) or active infection with Hepatitis
             C Virus (HCV) or Hepatitis B Virus (HBV) or any uncontrolled active systemic
             infection.

          -  Lactating or pregnant