NCT02437019

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 7, 2015

Completed
Last Updated

March 20, 2017

Status Verified

March 1, 2017

First QC Date

April 17, 2015

Last Update Submit

March 17, 2017

Conditions

B-cell Chronic Lymphocytic Leukemia

Keywords

PCI-32765IbrutinibEarly access programChronic lymphocytic leukemiaRelapsed or refractory chronic lymphocytic leukemia

Interventions

PCI-32765 (Ibrutinib)DRUG

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Barretos, Brazil

Location

Unknown Facility

Florianópolis, Brazil

Location

Unknown Facility

Fortaleza, Brazil

Location

Unknown Facility

Porto Alegre, Brazil

Location

Unknown Facility

Rio de Janeiro, Brazil

Location

Unknown Facility

São Paulo, Brazil

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellRecurrence

Interventions

ibrutinib

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Janssen-Cilag Farmaceutica Ltda. Clinical Trial

    Janssen-Cilag Farmaceutica Ltda.

    STUDY DIRECTOR

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2015

First Posted

May 7, 2015

Last Updated

March 20, 2017

Record last verified: 2017-03

Locations

BR(6)