Status:
RECRUITING
A Long-term Extension Study of PCI-32765 (Ibrutinib)
Lead Sponsor:
Janssen Research & Development, LLC
Collaborating Sponsors:
Pharmacyclics LLC.
Conditions:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolle...
Detailed Description
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 ibrutinib access to participants in completed ibrutinib s...
Eligibility Criteria
Inclusion
- Participants must be currently participating in an ibrutinib clinical study considered complete and have received at least 6 months of treatment with ibrutinib. At study entry, participants must be actively receiving treatment with single-agent ibrutinib; or participants must have participated in an ibrutinib randomized clinical study in which they initially received comparator treatment and now cross-over to ibrutinib. Note: A minimum of 6 months requirement for prior ibrutinib treatment will not be mandatory in this case and participants with less than 6 months will be required to have more frequent initial safety assessments; or participants must be currently participating in study PCI-32765LYM1002. At study entry, participants must be actively receiving combination treatment with ibrutinib and nivolumab or single-agent ibrutinib
- Investigator's assessment that the benefit of continued ibrutinib therapy as a single agent or in combination with nivolumab will outweigh the risks
- Agrees to protocol-defined use of effective contraception
- Negative blood or urine pregnancy test at screening
Exclusion
- 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
Key Trial Info
Start Date :
September 9 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 29 2027
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT01804686
Start Date
September 9 2013
End Date
January 29 2027
Last Update
December 19 2025
Active Locations (174)
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1
City of Hope Cancer Center
Duarte, California, United States, 91010
2
University of California San Diego Medical Center
La Jolla, California, United States, 92093
3
University of California Los Angeles
Los Angeles, California, United States, 90095
4
St. Joseph Hospital Center for Cancer Prevention and Treatment
Orange, California, United States, 92868