A Long-term Extension Study of PCI-32765 (Ibrutinib)

Official record

Identifier

NCT01804686

Recruiting locations

countries

United StatesArgentinaAustraliaBelgiumBrazilCanadaChinaColombiaCzechiaFranceGermanyGreeceHungaryIrelandIsraelItalyJapanMexicoNetherlandsPolandPortugalPuerto RicoRussiaSouth KoreaSpainSwedenTaiwanTurkey (Türkiye)UkraineUnited Kingdom

Interventions studied

Ibrutinib

Lead sponsor

Janssen Research & Development, LLC

Target enrolment

539 participants

Study type

INTERVENTIONAL

Phase

Phase 3

Status

Active, not recruiting

First posted

Mar 5, 2013

Last updated on the registry

Oct 1, 2026

Age

18 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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 interfere significantly with volunteer's participation in the study

Indexed under

Leukemia