A Long-term Extension Study of PCI-32765 (Ibrutinib) (NCT01804686) | Clinical Trial Compass
RecruitingPhase 3
A Long-term Extension Study of PCI-32765 (Ibrutinib)
United States, Argentina, Australia700 participantsStarted 2013-09-09
Plain-language 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 enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 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 in…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a long-term extension study of ibrutinib, does that mean patients must have already been in an earlier ibrutinib trial to be eligible — and if so, does my treatment history make me a potential candidate worth discussing with you?
2The main thing this study is measuring is how many participants experience adverse events over the long term — what kinds of side effects have already been observed with ibrutinib in earlier studies, and are there any that would be especially relevant given my specific diagnosis?
3Given that this is a Phase 3 long-term extension study, what does that mean about what is already known — and not yet known — about ibrutinib's safety and effectiveness over many years?
4My condition is one of several being studied here, ranging from CLL to Waldenstrom's to chronic graft-versus-host disease — how relevant do you think the data from patients with other conditions would be to understanding what I might expect?
5Compared to standard treatment options available to me right now, is there a reason you would recommend exploring this long-term extension study, or would it make more sense to pursue an established therapy first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants affected by an adverse event
Timeframe: Up to 30 days after the last dose of study drug, or until the start of a subsequent systemic anti-cancer therapy, if earlier