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

NCT01804686 · tracked via the Priya Life Science UK tracker

Sponsor

Janssen Research & Development, LLC

Phase

Phase 3

Started

2013-09-09

Last updated

2026-07-31

Condition(s) studied

Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaMantle Cell LymphomaFollicular LymphomaDiffuse Large B-cell LymphomaWaldenstrom MacroglobulinemiaChronic Graft Versus Host Disease

Investigational drug(s) / intervention(s)

Ibrutinib

Ibrutinib: Ibrutinib will be given orally as capsules, once daily continuously, according to the current dosing regimen established in the parent ibrutinib clinical study (560 mg, 420 mg, 280 mg, or 140 mg), at approximately the same time each day.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Number of participants affected by an adverse event — Up to 30 days after the last dose of study drug, or until the start of a subsequent systemic anti-cancer therapy, if earlier

Trial sites (175)

Facility	City	Region	Status
City of Hope Cancer Center	Duarte	California	Completed
University of California San Diego Medical Center	La Jolla	California	Completed
University of California Los Angeles	Los Angeles	California	Completed
St. Joseph Hospital Center for Cancer Prevention and Treatment	Orange	California	Recruiting
Stanford University Medical Center	Stanford	California	Completed
Stanford University	Stanford	California	Completed
Norwalk Medical Group	Norwalk	Connecticut	Completed
Northwest Georgia Oncology Centers PC	Marietta	Georgia	Completed
Northwestern University Hospital	Chicago	Illinois	Completed
Indiana University	Goshen	Indiana	Completed
Kansas University Medical Center	Westwood	Kansas	Completed
Louisville Oncology Suburban - Norton Cancer Institute	Louisville	Kentucky	Completed
Dana Farber Cancer Center	Boston	Massachusetts	Completed
University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	Completed
Battle Creek Health Systm	Battle Creek	Michigan	Completed
Karmanos Cancer Institute - Wayne State University	Detroit	Michigan	Completed
Washington University	St Louis	Missouri	Completed
Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	Completed
Hackensack University Medical Center	Hackensack	New Jersey	Completed
Weill Medical College of Cornell University	New York	New York	Completed
Memorial Sloan-Kettering Cancer Center	New York	New York	Completed
Southeastern Medical Oncology Center	Goldsboro	North Carolina	Completed
The Ohio State University- James Cancer Hospital	Columbus	Ohio	Recruiting
Willamette Valley Cancer Center	Eugene	Oregon	Recruiting
Kaiser Permanente	Portland	Oregon	Completed
University of Pennsylvania Medical Center	Philadelphia	Pennsylvania	Completed
Avera Medical Group	Sioux Falls	South Dakota	Recruiting
MD Anderson Cancer Center - University of Texas	Houston	Texas	Completed
University of Virginia	Charlottesville	Virginia	Completed
University of Washington	Seattle	Washington	Completed
West Virginia University	Morgantown	West Virginia	Completed
University of Wisconsin Carbone Cancer Center - Wisconsin Institute for Medical Research	Madison	Wisconsin	Completed
CEMIC Saavedra	Ciudad Autonoma Buenos Aires	Argentina	Active Not Recruiting
Fundaleu	Ciudad de Buenos Aires	Argentina	Completed
Royal Adelaide Hospital	Adelaide	Australia	Active Not Recruiting
John Fawkner Cancer Trial Centre	Coburg	Australia	Completed
Concord Hospital	Concord	Australia	Completed
Austin Health	Heidelberg	Australia	Completed
Peter MacCallum Cancer Centre	Melbourne	Australia	Completed
Royal Perth Hospital	Perth	Australia	Completed

+ 135 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01804686 on ClinicalTrials.gov ↗ ← All trials in the UK