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

Primary Purpose

B-cell Chronic Lymphocytic Leukemia

Status
Approved for marketing
Phase
Locations
Brazil
Study Type
Expanded Access
Intervention
PCI-32765 (Ibrutinib)
Sponsored by
Janssen-Cilag Farmaceutica Ltda.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for B-cell Chronic Lymphocytic Leukemia focused on measuring PCI-32765, Ibrutinib, Early access program, Chronic lymphocytic leukemia, Relapsed or refractory chronic lymphocytic leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 17, 2015
Last Updated
March 17, 2017
Sponsor
Janssen-Cilag Farmaceutica Ltda.
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1. Study Identification

Unique Protocol Identification Number
NCT02437019
Brief Title
Early Access Program (EAP) for Ibrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Official Title
An Early Access Program (EAP) for Ibrutinib (PCI-32765) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Study Type
Expanded Access

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Approved for marketing
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen-Cilag Farmaceutica Ltda.

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Chronic Lymphocytic Leukemia
Keywords
PCI-32765, Ibrutinib, Early access program, Chronic lymphocytic leukemia, Relapsed or refractory chronic lymphocytic leukemia

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
PCI-32765 (Ibrutinib)
Intervention Description
Participants will receive PCI-32765 (ibrutinib) 420 mg (three 140-mg capsules) oral once daily continuously on a 28-day cycle.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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): 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen-Cilag Farmaceutica Ltda. Clinical Trial
Organizational Affiliation
Janssen-Cilag Farmaceutica Ltda.
Official's Role
Study Director
Facility Information:
City
Barretos
Country
Brazil
City
Florianopolis
Country
Brazil
City
Fortaleza
Country
Brazil
City
Porto Alegre
Country
Brazil
City
Rio De Janeiro
Country
Brazil
City
Sao Paulo
Country
Brazil
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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