Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia
A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia
2 other identifiers
interventional
199
1 country
16
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2010
Longer than P75 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2010
CompletedFirst Posted
Study publicly available on registry
April 22, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2019
CompletedResults Posted
Study results publicly available
May 7, 2020
CompletedMay 27, 2020
March 1, 2020
8.9 years
April 19, 2010
January 29, 2020
May 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects With Adverse Events
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.
30 days after last dose of study drug, continue up to 6 months
Secondary Outcomes (3)
Progressive Disease (PD)
30 days after last dose of study drug, continue up to 6 months
Death Event
30 days after last dose of study drug
Documented Responses
30 days after last dose of study drug, continue up to 6 months
Study Arms (1)
PCI-32765
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pharmacyclics LLC.lead
- Janssen Research & Development, LLCcollaborator
Study Sites (16)
Stanford University
Stanford, California, 94305, United States
Unknown Facility
Stanford, California, 94305, United States
University of Chicago
Chicago, Illinois, 60637, United States
Unknown Facility
Boston, Massachusetts, 02215, United States
Unknown Facility
New Hyde Park, New York, 11042, United States
Unknown Facility
New York, New York, 10065, United States
Unknown Facility
Rochester, New York, 14642-0001, United States
Unknown Facility
Columbus, Ohio, 43210, United States
Unknown Facility
Springfield, Oregon, 97477, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Tyler, Texas, 75702, United States
Fletcher Allen Health Care and University of Vermont
Burlington, Vermont, 05405, United States
Unknown Facility
Vancouver, Washington, 98684, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, 98902, United States
Related Publications (3)
Byrd JC, Furman RR, Coutre SE, Flinn IW, Burger JA, Blum K, Sharman JP, Wierda W, Zhao W, Heerema NA, Luan Y, Liu EA, Dean JP, O'Brien S. Ibrutinib Treatment for First-Line and Relapsed/Refractory Chronic Lymphocytic Leukemia: Final Analysis of the Pivotal Phase Ib/II PCYC-1102 Study. Clin Cancer Res. 2020 Aug 1;26(15):3918-3927. doi: 10.1158/1078-0432.CCR-19-2856. Epub 2020 Mar 24.
PMID: 32209572DERIVEDCoutre SE, Byrd JC, Hillmen P, Barrientos JC, Barr PM, Devereux S, Robak T, Kipps TJ, Schuh A, Moreno C, Furman RR, Burger JA, O'Dwyer M, Ghia P, Valentino R, Chang S, Dean JP, James DF, O'Brien SM. Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies. Blood Adv. 2019 Jun 25;3(12):1799-1807. doi: 10.1182/bloodadvances.2018028761.
PMID: 31196847DERIVEDO'Brien S, Furman RR, Coutre S, Flinn IW, Burger JA, Blum K, Sharman J, Wierda W, Jones J, Zhao W, Heerema NA, Johnson AJ, Luan Y, James DF, Chu AD, Byrd JC. Single-agent ibrutinib in treatment-naive and relapsed/refractory chronic lymphocytic leukemia: a 5-year experience. Blood. 2018 Apr 26;131(17):1910-1919. doi: 10.1182/blood-2017-10-810044. Epub 2018 Feb 2.
PMID: 29437592DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- James Dean
- Organization
- Pharmacyclics
Study Officials
- STUDY DIRECTOR
James Dean, MD
Medical Monitor
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2010
First Posted
April 22, 2010
Study Start
June 1, 2010
Primary Completion
April 26, 2019
Study Completion
April 26, 2019
Last Updated
May 27, 2020
Results First Posted
May 7, 2020
Record last verified: 2020-03