Brief Title
Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia
Official Title
A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia
Brief 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).
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Number of Subjects With Adverse Events
Secondary Outcome
Progressive Disease (PD)
Condition
B-cell Chronic Lymphocytic Leukemia
Intervention
PCI-32765
Study Arms / Comparison Groups
PCI-32765
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
199
Start Date
June 2010
Completion Date
April 26, 2019
Primary Completion Date
April 26, 2019
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
James Dean, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01109069
Organization ID
PCYC-1103-CA
Secondary IDs
PCI-32765
Responsible Party
Sponsor
Study Sponsor
Pharmacyclics LLC.
Collaborators
Janssen Research & Development, LLC
Study Sponsor
James Dean, MD, Study Director, Medical Monitor
Verification Date
March 2020