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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01109069
Recruitment Status : Completed
First Posted : April 22, 2010
Results First Posted : May 7, 2020
Last Update Posted : May 27, 2020
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics LLC.

Tracking Information
First Submitted Date  ICMJE April 19, 2010
First Posted Date  ICMJE April 22, 2010
Results First Submitted Date  ICMJE January 29, 2020
Results First Posted Date  ICMJE May 7, 2020
Last Update Posted Date May 27, 2020
Study Start Date  ICMJE June 2010
Actual Primary Completion Date April 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2020)
Number of Subjects With Adverse Events [ Time Frame: 30 days after last dose of study drug, continue up to 6 months ]
Subjects were to receive ibrutinib once daily at the dose level the subject was receiving in the parent study until disease progression or unacceptable toxicity. The study included Screening, Treatment (from the first dose until study drug discontinuation), and Follow-up Phases.
Original Primary Outcome Measures  ICMJE
 (submitted: April 21, 2010)
Adverse Events/ Safety Tolerability [ Time Frame: 30 days after last dose of study drug ]
Frequency, severity, and relatedness of adverse events
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2020)
  • Progressive Disease (PD) [ Time Frame: 30 days after last dose of study drug, continue up to 6 months ]
    A progressive disease confirmed by a CT scan.
  • Death Event [ Time Frame: 30 days after last dose of study drug ]
    All death events are due to AE, progressive disease, and other reasons.
  • Documented Responses [ Time Frame: 30 days after last dose of study drug, continue up to 6 months ]
    Investigator-assessed responses were summarized descriptively for subjects with CLL/SLL and listed for subjects with other NHLs based on the efficacy population.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2010)
  • Tumor Response [ Time Frame: Frequency of tumor assessments done per standard of care ]
    tumor response will be assessed per established response criteria. This study will capture time to disease progression and duration of response.
  • Tumor Response [ Time Frame: Time to disease progression ]
    Duration of response as measured by established response criteria for B cell lymphoma and chronic lymphocytic leukemia
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia
Official Title  ICMJE 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE Drug: PCI-32765
Dose based on parent protocol
Study Arms  ICMJE Experimental: PCI-32765
Intervention: Drug: PCI-32765
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2019)
Original Estimated Enrollment  ICMJE
 (submitted: April 21, 2010)
Actual Study Completion Date  ICMJE April 26, 2019
Actual Primary Completion Date April 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01109069
Other Study ID Numbers  ICMJE PCYC-1103-CA
PCI-32765 ( Other Identifier: Pharmacyclics )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pharmacyclics LLC.
Study Sponsor  ICMJE Pharmacyclics LLC.
Collaborators  ICMJE Janssen Research & Development, LLC
Investigators  ICMJE
Study Director: James Dean, MD Medical Monitor
PRS Account Pharmacyclics LLC.
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP