A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study
18 Years
N/A
Both
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Diffuse Large B-cell Lymphoma
Trial Information
A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study
This is an open-label (identity of assigned study drug will be known) study designed to
collect long-term safety and efficacy data and provide PCI-32765 (Ibrutinib) access to
participants in completed PCI-32765 studies. Participants will continue with the current
PCI-32765 dosing regimen established in the parent PCI-32765 study until the investigator
determines that the participant is no longer benefitting from treatment (ie, disease
progression or unacceptable toxicity has occurred), the study is terminated by the sponsor,
the participant withdraws consent, alternative access to PCI-32765 is available and
feasible, or for other reasons as defined in the protocol. Safety will be monitored
throughout the study and summarized. Efficacy may be analyzed in combination with the data
collected in the parent protocol. There is no formal hypothesis testing planned for this
long-term extension study. Participants can receive a maximum of 3 years of treatment with
single-agent PCI-32765 in this study.
Inclusion Criteria:
- Participants must be currently in a PCI-32765 clinical study considered completed and
have received at least 6 months of treatment with PCI-32765
- At study entry, participants must be actively receiving treatment with single-agent
PCI-32765
- Agrees to protocol-defined use of effective contraception
- Negative blood or urine pregnancy test at screening
Exclusion Criteria:
- Requires anticoagulation with warfarin or equivalent vitamin K antagonists
- Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors, unless
previously approved by sponsor
- Any condition or situation which, in the opinion of the investigator, may put the
participant at significant risk, may confound the study results, or may interfere
significantly with volunteer's participation in the study
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of participants affected by an adverse event
Outcome Time Frame:
Up to 30 days after the last dose of study medication
Safety Issue:
Yes
Principal Investigator
Janssen Research & Development, LLC Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
Janssen Research & Development, LLC
Authority:
United States: Food and Drug Administration
Study ID:
CR100955
NCT ID:
NCT01804686
Start Date:
October 2013
Completion Date:
October 2016
Related Keywords:
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
- Mantle Cell Lymphoma
- Follicular Lymphoma
- Diffuse Large B-Cell Lymphoma
- Chronic lymphocytic leukemia
- Small lymphocytic lymphoma
- Mantle cell lymphoma
- Follicular lymphoma
- Diffuse large B-cell lymphoma
- PCI-32765
- Ibrutinib
- Bruton's tyrosine kinase inhibitor
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Mantle-Cell
Name | Location |
|---|---|
| Fountain Valley, California 92708 | |
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Austin, Texas 78705 | |
| McLean, Virginia 22101 | |
| Hackensack, New Jersey 07601 | |
| Milwaukee, Wisconsin |
