RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study

Quick Facts

Study Start:2013-09-09
Study Completion:2027-01-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01804686

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Investigator's assessment that the benefit of continued ibrutinib therapy as a single agent or in combination with nivolumab will outweigh the risks
  3. * Agrees to protocol-defined use of effective contraception
  4. * Negative blood or urine pregnancy test at screening
  1. * Requires anticoagulation with warfarin or equivalent vitamin K antagonists
  2. * Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors, unless previously approved by sponsor
  3. * 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

Contacts and Locations

Study Contact

Study Contact
CONTACT
Participate-In-This-Study@its.jnj.com

Principal Investigator

Janssen Research & Development, LLC Clinical Trial
STUDY_DIRECTOR
Janssen Research & Development, LLC

Study Locations (Sites)

City of Hope Cancer Center
Duarte, California, 91010
United States
University of California San Diego Medical Center
La Jolla, California, 92093
United States
University of California Los Angeles
Los Angeles, California, 90095
United States
St. Joseph Hospital Center for Cancer Prevention and Treatment
Orange, California, 92868
United States
Stanford University Medical Center
Stanford, California, 94305
United States
Stanford University
Stanford, California, 94305
United States
Norwalk Medical Group
Norwalk, Connecticut, 06850
United States
Northwest Georgia Oncology Centers PC
Marietta, Georgia, 30060
United States
Northwestern University Hospital
Chicago, Illinois, 60611
United States
Indiana University
Goshen, Indiana, 46526
United States
Kansas University Medical Center
Westwood, Kansas, 66205
United States
Louisville Oncology Suburban - Norton Cancer Institute
Louisville, Kentucky, 40207
United States
Dana Farber Cancer Center
Boston, Massachusetts, 02215
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
United States
Battle Creek Health Systm
Battle Creek, Michigan, 49016
United States
Karmanos Cancer Institute - Wayne State University
Detroit, Michigan, 48201
United States
Washington University
Saint Louis, Missouri, 63110
United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Weill Medical College of Cornell University
New York, New York, 10021
United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
United States
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27534
United States
The Ohio State University- James Cancer Hospital
Columbus, Ohio, 43210
United States
Willamette Valley Cancer Center
Eugene, Oregon, 97401
United States
Kaiser Permanente
Portland, Oregon, 97227
United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
United States
Avera Medical Group
Sioux Falls, South Dakota, 57105
United States
MD Anderson Cancer Center - University of Texas
Houston, Texas, 77030
United States
University of Virginia
Charlottesville, Virginia, 22908
United States
University of Washington
Seattle, Washington, 98109
United States
West Virginia University
Morgantown, West Virginia, 26506
United States
University of Wisconsin Carbone Cancer Center - Wisconsin Institute for Medical Research
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: Janssen Research & Development, LLC

  • Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-09-09
Study Completion Date2027-01-29

Study Record Updates

Study Start Date2013-09-09
Study Completion Date2027-01-29

Terms related to this study

Keywords Provided by Researchers

  • Chronic lymphocytic leukemia
  • Small lymphocytic lymphoma
  • Mantle cell lymphoma
  • Follicular lymphoma
  • Diffuse large B-cell lymphoma
  • PCI-32765
  • Ibrutinib
  • Bruton's tyrosine kinase inhibitor
  • IMBRUVICA
  • JNJ-54179060

Additional Relevant MeSH Terms

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • Mantle Cell Lymphoma
  • Follicular Lymphoma
  • Diffuse Large B-cell Lymphoma
  • Waldenstrom Macroglobulinemia
  • Chronic Graft Versus Host Disease