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B-cell Chronic Lymphocytic LeukemiaNCT02437019

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

A study testing PCI-32765 (Ibrutinib) in people with B-cell Chronic Lymphocytic Leukemia, run by Janssen-Cilag Farmaceutica Ltda. at 6 sites in Brazil.

Approved For Marketing

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-cell Chronic Lymphocytic Leukemia
What is being tested?
PCI-32765 (Ibrutinib)
Type of treatment
Pill or oral medicine
How many people
Not given
Where
6 sitesBrazil
Study dates
Start not givento not given
Phase
Expanded access
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Brazil6 sites

  • Study site

    Barretos

  • Study site

    Florianópolis

  • Study site

    Fortaleza

  • Study site

    Porto Alegre

  • Study site

    Rio de Janeiro

  • Study site

    São Paulo

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Being tested
PCI-32765 (Ibrutinib)
Keywords
PCI-32765, Ibrutinib, Early access program, Chronic lymphocytic leukemia, Relapsed or refractory chronic lymphocytic leukemia
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT02437019
Sponsor's protocol ID
CR106344
Other IDs
54179060CLL3005
Status last verified
Mar 2017
First submitted
17 Apr 2015
Last updated
20 Mar 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing PCI-32765 (Ibrutinib) in people with B-cell Chronic Lymphocytic Leukemia, run by Janssen-Cilag Farmaceutica Ltda. at 6 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02437019.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017.

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