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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02437019
Expanded Access Status : Approved for marketing
First Posted : May 7, 2015
Last Update Posted : March 20, 2017
Information provided by (Responsible Party):
Janssen-Cilag Farmaceutica Ltda.

Brief Summary:
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.

Condition or disease Intervention/treatment
B-cell Chronic Lymphocytic Leukemia Drug: PCI-32765 (Ibrutinib)

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.

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Study Type : Expanded Access
Official Title: An Early Access Program (EAP) for Ibrutinib (PCI-32765) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Intervention Details:
  • Drug: PCI-32765 (Ibrutinib)
    Participants will receive PCI-32765 (ibrutinib) 420 mg (three 140-mg capsules) oral once daily continuously on a 28-day cycle.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02437019

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Barretos, Brazil
Florianopolis, Brazil
Fortaleza, Brazil
Porto Alegre, Brazil
Rio De Janeiro, Brazil
Sao Paulo, Brazil
São Paulo, Brazil
Sponsors and Collaborators
Janssen-Cilag Farmaceutica Ltda.
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Study Director: Janssen-Cilag Farmaceutica Ltda. Clinical Trial Janssen-Cilag Farmaceutica Ltda.
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Responsible Party: Janssen-Cilag Farmaceutica Ltda. Identifier: NCT02437019    
Other Study ID Numbers: CR106344
54179060CLL3005 ( Other Identifier: Janssen-Cilag Farmaceutica Ltda. )
First Posted: May 7, 2015    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017
Keywords provided by Janssen-Cilag Farmaceutica Ltda.:
Early access program
Chronic lymphocytic leukemia
Relapsed or refractory chronic lymphocytic leukemia
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell