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

Phase 2
18 Years
Open (Enrolling by invite only)
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

Thank you

Trial Information

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse Events/ Safety Tolerability

Outcome Description:

Frequency, severity, and relatedness of adverse events

Outcome Time Frame:

30 days after last dose of study drug

Safety Issue:


Principal Investigator

Alvina Chu, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2010

Completion Date:

April 2016

Related Keywords:

  • 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
  • Waldenström Macroglobulinemia
  • Burkitt Lymphoma
  • B-Cell Diffuse Lymphoma
  • PCI-32765
  • Lymphoma, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, B-Cell
  • Bruton's Tyrosine Kinase
  • Burkitt Lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin
  • Waldenstrom Macroglobulinemia
  • Lymphoma, B-Cell
  • Lymphoma, Mantle-Cell



MD Anderson Cancer CenterHouston, Texas  77030-4096
University of Rochester Cancer CenterRochester, New York  14642
Stanford University School of MedicineStanford, California  94305-5317
The Ohio State UniversityColumbus, Ohio  43210
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Northwest Cancer Specialist, P.C.Vancouver, Washington  98686
Sarah CannonNashville, Tennessee  37203
Texas Oncology - TylerTyler, Texas  75702
University of Texas, MD AndersonHouston, Texas  77030
University of Vermont and Fletcher Allen Health CareBurlington, Vermont  05405
CLL Research and Treatment ProgramNew Hyde Park, New York  11042
New York Presbyterian Hospital Cornell Medical CenterNew York, New York  10065
Willametter Valley Cancer InstituteSpringfield, Oregon  97477
Yakima Valley Memorial Hospital /North Star LodgeYakima, Washington  98902