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Chronic Lymphocytic LeukemiaPhase 3CAN3001NCT01804686

A Long-term Extension Study of PCI-32765 (Ibrutinib)

A Phase 3 study testing Ibrutinib in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Janssen Research & Development, LLC at 156 sites in 29 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ibrutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
539 participants
Where
156 sitesin 29 countries
Study dates
9 Sep 2013to 31 Dec 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Participants must be currently participating in an ibrutinib clinical study considered complete and have received at least 6 months of treatment with ibrutinib. At study entry, participants must be actively receiving treatment with single-agent ibrutinib; or participants must have participated in an ibrutinib randomized clinical study in which they initially received comparator treatment and now cross-over to ibrutinib. Note: A minimum of 6 months requirement for prior ibrutinib treatment will not be mandatory in this case and participants with less than 6 months will be required to have more frequent initial safety assessments; or participants must be currently participating in study PCI-32765LYM1002. At study entry, participants must be actively receiving combination treatment with ibrutinib and nivolumab or single-agent ibrutinib
  • Investigator's assessment that the benefit of continued ibrutinib therapy as a single agent or in combination with nivolumab will outweigh the risks
  • Agrees to protocol-defined use of effective contraception
  • Negative blood or urine pregnancy test at screening

Who cannot join

  • Requires anticoagulation with warfarin or equivalent vitamin K antagonists
  • Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors, unless previously approved by sponsor
  • Any condition or situation which, in the opinion of the investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with volunteer's participation in the study

Trial locations and contacts

156 sites in 29 countries.

156 sites in 29 countries

United States30 sites

  • Study site

    Ann Arbor, Michigan

  • Study site

    Battle Creek, Michigan

  • Study site

    Boston, Massachusetts

  • Study site

    Charlottesville, Virginia

  • Study site

    Chicago, Illinois

  • Study site

    Columbus, Ohio

  • Study site

    Detroit, Michigan

  • Study site

    Duarte, California

  • Study site

    Eugene, Oregon

  • Study site

    Goldsboro, North Carolina

  • Study site

    Goshen, Indiana

  • Study site

    Hackensack, New Jersey

  • Study site

    Houston, Texas

  • Study site

    La Jolla, California

  • Study site

    Lebanon, New Hampshire

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Madison, Wisconsin

  • Study site

    Marietta, Georgia

  • Study site

    Morgantown, West Virginia

  • Study site

    New York, New York

  • Study site

    Norwalk, Connecticut

  • Study site

    Orange, California

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Portland, Oregon

  • Study site

    Seattle, Washington

  • Study site

    Sioux Falls, South Dakota

  • Study site

    St Louis, Missouri

  • Study site

    Stanford, California

  • Study site

    Westwood, Kansas

Other trials in United States

Russia15 sites

  • Study site

    Arkhangelsk

  • Study site

    Chelyabinsk

  • Study site

    Dzerzhinsk

  • Study site

    Moscow

  • Study site

    Nizhny Novgorod

  • Study site

    Obninsk

  • Study site

    Perm

  • Study site

    Petrozavodsk

  • Study site

    Rostov-on-Don

  • Study site

    Ryazan

  • Study site

    Saint

  • Study site

    Saint Petersburg

  • Study site

    Samara

  • Study site

    Sochi

  • Study site

    Syktyvkar

Other trials in Russia

United Kingdom14 sites

  • Study site

    Birmingham

  • Study site

    Bournemouth

  • Study site

    Colchester

  • Study site

    Glasgow

  • Study site

    Leeds

  • Study site

    Leicester

  • Study site

    London

  • Study site

    Manchester

  • Study site

    Newcastle upon Tyne

  • Study site

    Nottingham

  • Study site

    Plymouth

  • Study site

    Sheffield

  • Study site

    Southampton

  • Study site

    Sutton

Other trials in United Kingdom

China10 sites

  • Study site

    Beijing

  • Study site

    Chengdu

  • Study site

    Fuzhou

  • Study site

    Guangzhou

  • Study site

    Hangzhou

  • Study site

    Shanghai

  • Study site

    Shanxi

  • Study site

    Suzhou

  • Study site

    Tianjin

  • Study site

    Wuhan

Other trials in China

Germany9 sites

  • Study site

    Berlin

  • Study site

    Dresden

  • Study site

    Essen

  • Study site

    Giessen

  • Study site

    Heidelberg

  • Study site

    Homburg/Saar

  • Study site

    Magdeburg

  • Study site

    Marburg

  • Study site

    Ulm

Other trials in Germany

Australia8 sites

  • Study site

    Adelaide

  • Study site

    Coburg

  • Study site

    Concord

  • Study site

    Heidelberg

  • Study site

    Melbourne

  • Study site

    Perth

  • Study site

    Prahran

  • Study site

    Wahroonga

Other trials in Australia

Poland8 sites

  • Study site

    Brzozów

  • Study site

    Chorzów

  • Study site

    Gdansk

  • Study site

    Klinika Nowotworow Ukladu Chlonnego

  • Study site

    Krakow

  • Study site

    Opole

  • Study site

    Słupsk

  • Study site

    Wroclaw

Other trials in Poland

Ukraine7 sites

  • Study site

    Cherkasy

  • Study site

    Dnipro

  • Study site

    Kharkiv

  • Study site

    Khmelnitskiy

  • Study site

    Kiev

  • Study site

    Lviv

  • Study site

    Vinnitsa

Other trials in Ukraine

Belgium6 sites

  • Study site

    Antwerp

  • Study site

    Bruges

  • Study site

    Brussels

  • Study site

    Ghent

  • Study site

    Leuven

  • Study site

    Yvoir

Other trials in Belgium

France6 sites

  • Study site

    Créteil

  • Study site

    Mulhouse

  • Study site

    Paris

  • Study site

    Pessac

  • Study site

    Pierre-Bénite

  • Study site

    Tours

Other trials in France

Israel6 sites

  • Study site

    Afula

  • Study site

    Hadera

  • Study site

    Haifa

  • Study site

    Petah Tikva

  • Study site

    Ramat Gan

  • Study site

    Tel Aviv

Other trials in Israel

Spain5 sites

  • Study site

    Barcelona

  • Study site

    L'Hospitalet de Llobregat

  • Study site

    Madrid

  • Study site

    Pamplona

  • Study site

    Salamanca

Other trials in Spain

Turkey (Türkiye)4 sites

  • Study site

    Ankara

  • Study site

    Istanbul

  • Study site

    Izmir

  • Study site

    Kayseri

Other trials in Turkey (Türkiye)

Brazil3 sites

  • Study site

    Rio de Janeiro

  • Study site

    Salvador

  • Study site

    São Paulo

Other trials in Brazil

Sweden3 sites

  • Study site

    Gothenburg

  • Study site

    Lund

  • Study site

    Stockholm

Other trials in Sweden

Argentina2 sites

  • Study site

    Ciudad Autonoma Buenos Aires

  • Study site

    Ciudad de Buenos Aires

Other trials in Argentina

Colombia2 sites

  • Study site

    Bogotá

  • Study site

    Floridablanca

Other trials in Colombia

Czechia2 sites

  • Study site

    Brno

  • Study site

    Prague

Other trials in Czechia

Greece2 sites

  • Study site

    Athens

  • Study site

    Thessalonikis

Other trials in Greece

Hungary2 sites

  • Study site

    Budapest

  • Study site

    Szeged

Other trials in Hungary

Japan2 sites

  • Study site

    Bunkyō City

  • Study site

    Hiroshima

Other trials in Japan

Portugal2 sites

  • Study site

    Lisbon

  • Study site

    Porto

Other trials in Portugal

South Korea2 sites

  • Study site

    Goyang-si

  • Study site

    Seoul

Other trials in South Korea

Canada1 site

  • Study site

    Montreal, Quebec

Other trials in Canada

Ireland1 site

  • Study site

    Dublin

Other trials in Ireland

Mexico1 site

  • Study site

    Oaxaca City

Other trials in Mexico

Netherlands1 site

  • Study site

    Amsterdam

Other trials in Netherlands

Puerto Rico1 site

  • Study site

    San Juan

Other trials in Puerto Rico

Taiwan1 site

  • Study site

    Changhua County

Other trials in Taiwan

About this study

Official title: PCI-32765CAN3001: A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study

The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.

Read the detailed description

This is an open-label (identity of assigned study drug will be known) study designed to collect long-term safety and efficacy data and provide ibrutinib access to participants in completed ibrutinib studies. PCI-32765 (Ibrutinib) is a first-in-class, potent, orally-administered, covalently-binding small molecule inhibitor of bruton's tyrosine kinase. "PCI-32765" and "ibrutinib" refer to the same molecule; hereafter, "ibrutinib" will be used. Participants will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study until the investigator determines that the participant is no longer benefitting from treatment (ie, disease progression or unacceptable toxicity has occurred), the participant withdraws consent, alternative access to ibrutinib is available and feasible (example, participant assistance program or commercial source of ibrutinib), or for other reasons as defined in the protocol, or until the end of the study, whichever occurs earlier. Safety will be monitored throughout the study and summarized. Efficacy may be analyzed in combination with the data collected in the parent protocol. There is no formal hypothesis testing planned for this long-term extension study. Participants for whom alternative access to ibrutinib is not available and feasible can receive treatment with single-agent ibrutinib until end of study, which is defined as the time when all participants still receiving study treatment have transitioned to commercial or alternative access to ibrutinib, have stopped receiving ibrutinib treatment, or upon a decision by the sponsor to terminate the study, whichever occurs earlier.

Being tested
Ibrutinib
Keywords
Chronic lymphocytic leukemia, Small lymphocytic lymphoma, Mantle cell lymphoma, Follicular lymphoma, Diffuse large B-cell lymphoma, PCI-32765, Ibrutinib, Bruton's tyrosine kinase inhibitor, IMBRUVICA, JNJ-54179060
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Waldenstrom Macroglobulinemia, Bronchiolitis Obliterans Syndrome

What participants receive

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

  • IbrutinibDrug

    Also called PCI-32765

    Ibrutinib will be given orally as capsules, once daily continuously, according to the current dosing regimen established in the parent ibrutinib clinical study (560 mg, 420 mg, 280 mg, or 140 mg), at approximately the same time each day.

Study groups in NCT01804686
Study groupRoleWhat they receive
IbrutinibExperimentalNot described
Receives: Drug: Ibrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants affected by an adverse event

    Measured: Up to 30 days after the last dose of study drug, or until the start of a subsequent systemic anti-cancer therapy, if earlier

Secondary outcomes (1)

  1. Number of participants with change in disease status

    Measured: Up to the end-of-treatment visit (up to 30 days after the last dose of study medication), or until the start of a subsequent anti-caner therapy, if earlier

Timeline

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

  1. First posted5 Mar 2013 (estimated)
  2. Study start9 Sep 2013
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
539 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01804686
Sponsor's protocol ID
CR100955
Other IDs
PCI-32765CAN3001, 2012-004225-24
Acronym
CAN3001
Status last verified
Nov 2026
First submitted
4 Mar 2013
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ibrutinib in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Janssen Research & Development, LLC at 156 sites in 29 countries.

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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 156 sites in United States, Russia, United Kingdom, China, Germany and 24 more countries. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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.

What does the primary outcome measure?

Number of participants affected by an adverse event (time frame: Up to 30 days after the last dose of study drug, or until the start of a subsequent systemic anti-cancer therapy, if earlier). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01804686.

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 3 Nov 2026.

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