RECRUITING

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

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.

Conditions

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

Related Conditions:

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

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Chronic Lymphocytic Leukemia
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope Cancer Center, Duarte, California, United States, 91010

La Jolla

University of California San Diego Medical Center, La Jolla, California, United States, 92093

Los Angeles

University of California Los Angeles, Los Angeles, California, United States, 90095

Orange

St. Joseph Hospital Center for Cancer Prevention and Treatment, Orange, California, United States, 92868

Stanford

Stanford University Medical Center, Stanford, California, United States, 94305

Stanford

Stanford University, Stanford, California, United States, 94305

Norwalk

Norwalk Medical Group, Norwalk, Connecticut, United States, 06850

Marietta

Northwest Georgia Oncology Centers PC, Marietta, Georgia, United States, 30060

Chicago

Northwestern University Hospital, Chicago, Illinois, United States, 60611

Goshen

Indiana University, Goshen, Indiana, United States, 46526

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janssen Research & Development, LLC,

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

Study Record Dates

2027-01-29