Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia

Not Recruiting

Trial ID: NCT01109069


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).

Official Title

A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia

Stanford Investigator(s)

Ranjana Advani
Ranjana Advani

Saul A. Rosenberg, MD, Professor of Lymphoma


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

   - Lactating or pregnant


drug: PCI-32765

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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