Early Access Program (EAP) for Ibrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

March 17, 2017 updated by: Janssen-Cilag Farmaceutica Ltda.

An Early Access Program (EAP) for Ibrutinib (PCI-32765) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

The purpose of this study is to provide early access to Ibrutinib treatment for participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) and collect additional safety data while the medication is not commercially available.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Approved for marketing

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an open-label (all people know the identity of the intervention), multi-center (when more than one hospital or medical school team work on a medical research study) early access program (EAP) study. The study will be conducted in 2 phases: a Screening Phase (approximately 30 days prior to administration of first dose) and a Program Drug Phase (Day 1 up to 30 Days after last dose of study drug). Enrolled participants will receive 420 milligram (mg) oral ibrutinib once daily on a 28-day cycle until disease progression, occurrence of unacceptable toxicity, no longer achieving clinical benefit, or the end of program. Treatment will be continuous (without interruption) and self-administered. Disease evaluations will be conducted according to local standard of care as clinically indicated. Participant's safety will be monitored throughout the study. All enrolled and on-going participants in the program will continue to receive ibrutinib by the EAP until marketing approval or 6 months after this date.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Barretos, Brazil
      • Florianopolis, Brazil
      • Fortaleza, Brazil
      • Porto Alegre, Brazil
      • Rio De Janeiro, Brazil
      • Sao Paulo, Brazil
      • São Paulo, Brazil

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Has Eastern Cooperative Oncology Group (ECOG) performance status of less than (<) 2

  • Has a diagnosis of Chronic Lymphocytic Leukemia (CLL) that meets published diagnostic criteria (Hallek 2008):

    1. Monoclonal B-cells (either kappa or lambda light chain restricted) that are clonally co-expressing at least one B-cell marker (Cluster of Differentiation 19 [CD19], CD20, or CD23) and CD5
    2. The diagnosis of CLL requires a history of lymphocytosis with a B-lymphocyte count greater than or equal to (>=) 5,000/microliter (μl)
  • Active disease meeting at least one of the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria
  • Must have received at least one prior therapy for CLL and not be appropriate for treatment or retreatment with purine analog based therapy
  • Able to receive all outpatient treatment and all laboratorial monitoring at the institution that administers program drug

Exclusion Criteria:

  • Known central nervous system (CNS) lymphoma or leukemia
  • Known prolymphocytic leukemia or history of or currently suspected Richter's transformation
  • Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP)
  • Prior exposure to ibrutinib or randomization in an ibrutinib study
  • Requires treatment with a strong Cytochrome P3A4/5 (that is, CYP3A4/5) Inhibitor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen-Cilag Farmaceutica Ltda.

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

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR106344
  • 54179060CLL3005 (Other Identifier: Janssen-Cilag Farmaceutica Ltda.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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