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New treatment option for Chronic Lymphocytic Leukemia
Official title A Long-term Extension Study of PCI-32765 (Ibrutinib)
ClinicalTrials.gov ID: NCT01804686
What this study is testing
What is Ibrutinib?
Ibrutinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic lymphocytic leukemia.
Also referred to as PCI-32765.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must be currently participating in an ibrutinib clinical study considered complete and have received at least 6 months of treatment with...
- 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
You likely can't join if
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Stanford, California, United States
- Norwalk, Connecticut, United States
- Marietta, Georgia, United States
- Chicago, Illinois, United States
- Goshen, Indiana, United States
- Westwood, Kansas, United States
- Louisville, Kentucky, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Battle Creek, Michigan, United States
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- Lebanon, New Hampshire, United States
- Hackensack, New Jersey, United States
- New York, New York, United States
- Goldsboro, North Carolina, United States
+ 139 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; La Jolla, California, United States; Los Angeles, California, United States; Orange, California, United States; Stanford, California, United States; Norwalk, Connecticut, United States and 153 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.