AzTrials
AzTrials

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 175 sites in 30 countries.

Active, not recruiting

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

Official record
Search all trials

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
175 sitesin 30 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

175 sites in 30 countries.

175 sites in 30 countries

United States32 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Battle Creek Health Systm

    Battle Creek, Michigan, 49016

  • Dana Farber Cancer Center

    Boston, Massachusetts, 02215

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Northwestern University Hospital

    Chicago, Illinois, 60611

  • The Ohio State University- James Cancer Hospital

    Columbus, Ohio, 43210

  • Karmanos Cancer Institute - Wayne State University

    Detroit, Michigan, 48201

  • City of Hope Cancer Center

    Duarte, California, 91010

  • Willamette Valley Cancer Center

    Eugene, Oregon, 97401

  • Southeastern Medical Oncology Center

    Goldsboro, North Carolina, 27534

  • Indiana University

    Goshen, Indiana, 46526

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • MD Anderson Cancer Center - University of Texas

    Houston, Texas, 77030

  • University of California San Diego Medical Center

    La Jolla, California, 92093

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of California Los Angeles

    Los Angeles, California, 90095

  • Louisville Oncology Suburban - Norton Cancer Institute

    Louisville, Kentucky, 40207

  • University of Wisconsin Carbone Cancer Center - Wisconsin Institute for Medical Research

    Madison, Wisconsin, 53705

  • Northwest Georgia Oncology Centers PC

    Marietta, Georgia, 30060

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Weill Medical College of Cornell University

    New York, New York, 10021

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Norwalk Medical Group

    Norwalk, Connecticut, 06850

  • St. Joseph Hospital Center for Cancer Prevention and Treatment

    Orange, California, 92868

  • University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104

  • Kaiser Permanente

    Portland, Oregon, 97227

  • University of Washington

    Seattle, Washington, 98109

  • Avera Medical Group

    Sioux Falls, South Dakota, 57105

  • Washington University

    St Louis, Missouri, 63110

  • Stanford University Medical Center

    Stanford, California, 94305

  • Stanford University

    Stanford, California, 94305

  • Kansas University Medical Center

    Westwood, Kansas, 66205

Other trials in United States

Russia18 sites

  • Arkhangelsk Regional Clinical Hospital

    Arkhangelsk, 163045

  • Chelyabinsk Regiona Onc. Center

    Chelyabinsk, 454087

  • Emergency Hospital of Dzerzhinsk

    Dzerzhinsk, 606019

  • Cancer Research Center

    Moscow, 115478

  • S.P. Botkin Moscow City Clinical Hospital

    Moscow, 125284

  • Regional Clinical Hospital n.a.Semashko

    Nizhny Novgorod, 603126

  • Medical Scientific Radiology - Center

    Obninsk, 249020

  • Perm Medical Sanitary Unit#1

    Perm, 614078

  • Republican Hospital named by V.A.Baranova

    Petrozavodsk, 185019

  • Rostov Research Institute of Oncology

    Rostov-on-Don, 344037

  • Ryazan Regional Clinical Hospital

    Ryazan, 390039

  • Leningrad region clinical hospital

    Saint, 194291

  • Clinical Research Institute of Hematology and Transfusiology

    Saint Petersburg, 193024

  • Federal Center of Heart, Blood and Endocrinology

    Saint Petersburg, 197341

  • City Clinical Oncology Dispensary

    Saint Petersburg, 198255

  • Samara Region Clinical Hospital

    Samara, 443095

  • Oncological dispensary #2

    Sochi, 354057

  • Oncology Dispensary of Komi Republic

    Syktyvkar, 167904

Other trials in Russia

United Kingdom16 sites

  • University Hospitals Birmingham NHS Trust,

    Birmingham, B15 2TH

  • Royal Bournemouth Hospital

    Bournemouth, BH7 7DW

  • Colchester Hospital University NHS

    Colchester, CO4 5JL

  • Beatson West Of Scotland Cancer Centre

    Glasgow, G12 0YN

  • St James's Institute of Oncology

    Leeds, LS9 7TF

  • Leicester Royal Infirmary - Haematology

    Leicester, LE1 5WW

  • St Bartholomew's Hospital - Dept of Haematology

    London, EC1A 7BE

  • University College London Hospitals NHSFT

    London, NW1 2BU

  • Kings College Hospital

    London, SE5 9RS

  • Christie Hospital

    Manchester, 00000

  • Freeman Hospital Newcastle upon Tyne Hosptials NHS Foundation Trust

    Newcastle upon Tyne, NE7 7DN

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB

  • Derriford Hospital

    Plymouth, PL6 8DH

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF

  • Southampton General Hospital

    Southampton, SO16 6YD

  • Royal Marsden Hospital (Sutton)

    Sutton, SM2 5PT

Other trials in United Kingdom

China12 sites

  • Peking University People's Hospital

    Beijing, 100044

  • Peking University Third Hospital

    Beijing, 100083

  • Peking University First Hospital

    Beijing

  • West China Hospital Sichuan University

    Chengdu, 610041

  • Fujian Medical University

    Fuzhou, 350001

  • Sun Yat-sen University Cancer Hospital

    Guangzhou, 510060

  • Zhejiang University First Hospital

    Hangzhou, 310003

  • Ruijin Hospital

    Shanghai, 200025

  • Tangdu hospital the Fourth Military Medical

    Shanxi, 710038

  • The First Affliated Hospital of Soochow University

    Suzhou

  • The Institute of Hematological disease

    Tianjin, 300070

  • Wuhan Union Hospital

    Wuhan, 430023

Other trials in China

Germany9 sites

  • Vivantes Klinikum Spandau-Klinik f. Innere Medizin Hämatologie/Onkologie/Gastroenterologie - Germany

    Berlin, 13589

  • Universitätsklinikum Carl Gustav Carus; Med. Klinik und Poliklinik I - Hämatologische Ambulanz, Haus

    Dresden, 01307

  • Universitätsklinikum Essen; Klinik f. Hämatologie- Germany

    Essen, 45122

  • Justus-Liebig-Universitaet - Medizinische Klinik IV, Haematologie

    Giessen, 35592

  • Universitätsklinikum Heidelberg Med. Klinik IV

    Heidelberg, 69120

  • Universitätsklinikum des Saarlandes

    Homburg/Saar, 66424

  • Gemeinschaftspraxis Dres. Uhle/Müller/Kröning/Jentsch-Ullrich - Germany

    Magdeburg, 39104

  • OnkoNet Marburg GmbH

    Marburg, 35037

  • Universitätsklinikum für Innere Med. III_Hämatologie, Onkologie...- Germany

    Ulm, 89081

Other trials in Germany

Australia8 sites

  • Royal Adelaide Hospital

    Adelaide, 5000

  • John Fawkner Cancer Trial Centre

    Coburg, 3058

  • Concord Hospital

    Concord, 2139

  • Austin Health

    Heidelberg, 3084

  • Peter MacCallum Cancer Centre

    Melbourne, 3000

  • Royal Perth Hospital

    Perth, 6847

  • Alfred Hospital

    Prahran, 3181

  • Adventist Health Care Limited trading as San Clinical Trials Unit

    Wahroonga, 2076

Other trials in Australia

Poland8 sites

  • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza

    Brzozów, 36-200

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

    Chorzów, 41-500

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Klinika Nowotworow Ukladu Chlonnego, 02 781

  • Pratia MCM Krakow

    Krakow, 30-727

  • Oddzial Hematologii

    Opole, 45-061

  • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka

    Słupsk, 76-200

  • Katedra I Klinika Hematologii Nowotworow Krwi I Transplantacji Szpiku

    Wroclaw, 50 367

Other trials in Poland

Spain8 sites

  • Hospital Vall d'Hebron

    Barcelona, 00000

  • Inst. Cat. Doncologia-H Duran I Reynals

    L'Hospitalet de Llobregat, 08907

  • Hosp. Univ. de La Princesa

    Madrid, 28006

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007

  • Hosp. Univ. Infanta Leonor

    Madrid, 28031

  • Fundacion Jimenez Diaz

    Madrid, 28040

  • Clinica Universitaria de Navarra

    Pamplona, 31008

  • Hospital Clinico Universitario Salamanca

    Salamanca, 37007

Other trials in Spain

France7 sites

  • Hopital Henri Mondor

    Créteil, 94010

  • Hôpital E. Muller

    Mulhouse, 68100

  • HOPITAL SAINT LOUIS - Hematology / Oncology

    Paris, 75010

  • Hopital Necker Enfants Malades

    Paris, 75743

  • Hopital Haut Leveque Service Maladie Du Sang

    Pessac, 33604

  • CH LYON SUD - Hematology

    Pierre-Bénite, 69310

  • CHU de Tours

    Tours, 37044

Other trials in France

Ukraine7 sites

  • CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC

    Cherkasy, 18009

  • Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center

    Dnipro, 49102

  • SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine

    Kharkiv, 61024

  • Khmelnitskiy Regional Hospital, Hematology Department

    Khmelnitskiy, 29000

  • State Institution Scientific Center for Radiation Medicine Academy of Medical Sciences of Ukraine

    Kiev, 03115

  • Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine

    Lviv, 79044

  • Vinnytsya Regional Clinical Hospital named after M.I.Pirogov

    Vinnitsa, 21018

Other trials in Ukraine

Belgium6 sites

  • UZA

    Antwerp, 2650

  • A.Z. Sint Jan

    Bruges, 8000

  • UCL - Saint Luc

    Brussels, 1200

  • UZ Gent - departement oncologie

    Ghent, 9000

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • UCL Mont-Godinne

    Yvoir, 5530

Other trials in Belgium

Israel6 sites

  • Haemek Medical Center

    Afula

  • Hillel Yaffe Medical Center - Oncology

    Hadera, 38100

  • Rambam Health Care Campus

    Haifa, 31096

  • Rabin Medical Center Beilinson Campus

    Petah Tikva, 4941492

  • Sheba Medical Center

    Ramat Gan, 52621

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Turkey (Türkiye)5 sites

  • Ankara University

    Ankara, 6590

  • American Hospital

    Istanbul, 34365

  • Istanbul University

    Istanbul, 34390

  • Dokuz Eylul Universitesi Tip Fakultesi

    Izmir, 35340

  • Erciyes University

    Kayseri, 38039

Other trials in Turkey (Türkiye)

Brazil3 sites

  • Ministerio da Saude Instituto Nacional do Cancer

    Rio de Janeiro, 20231 050

  • Santa Casa da Misericórdia da Bahia - Hospital Santa Isabel

    Salvador, 40050 410

  • Instituto de Ensino e Pesquisa São Lucas

    São Paulo, 01236-030

Other trials in Brazil

Czechia3 sites

  • Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika

    Brno, 625 00

  • Fakultni nemocnice Kralovske Vinohrady - Interni hematologicka klinika

    Prague, 100 34

  • Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie

    Prague, 128 08

Other trials in Czechia

Italy3 sites

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA''

    Roma, 00161

  • A.O.Citta della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

Portugal3 sites

  • Instituto Portugues de Oncologia Lisboa

    Lisbon, 1600

  • Hospital De Santa Maria

    Lisbon, 1649-035

  • Instituto Portugues de Oncologia Porto

    Porto, 4200072

Other trials in Portugal

Sweden3 sites

  • Sahlgrenska University hospital, Hematology Dept

    Gothenburg, SE-413 45

  • Skanes universitetssjukhus

    Lund, 22185

  • Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm

    Stockholm, 171 76

Other trials in Sweden

Argentina2 sites

  • CEMIC Saavedra

    Ciudad Autonoma Buenos Aires, C1431

  • Fundaleu

    Ciudad de Buenos Aires, C1114AAP

Other trials in Argentina

Colombia2 sites

  • Fundacion Santa Fe

    Bogotá

  • Fundacion Oftalmologica de Santander - FOSCAL

    Floridablanca, 681002

Other trials in Colombia

Greece2 sites

  • Laiko General Hospital - 1st department of Internal Medicine

    Athens, 115 27

  • G Papanikolaou Hospital of Thessaloniki

    Thessalonikis, 570 10

Other trials in Greece

Hungary2 sites

  • Semmelweis Egyetem, I. Belgyogyaszati Klinika

    Budapest, 1083

  • Szegedi Tudomanyegyetem II. Belgyogyaszati Klinika

    Szeged, 6725

Other trials in Hungary

Japan2 sites

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    Bunkyō City, 113 8677

  • Hiroshima University Hospital

    Hiroshima, 734 8551

Other trials in Japan

South Korea2 sites

  • National Cancer Center

    Goyang-si, 10408

  • The Catholic University of Korea Seoul St Mary s Hospital

    Seoul, 06591

Other trials in South Korea

Canada1 site

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

Other trials in Canada

Ireland1 site

  • St James's Hospital

    Dublin, 00000

Other trials in Ireland

Mexico1 site

  • Oaxaca Site Management Organization S.C.

    Oaxaca City, 68000

Other trials in Mexico

Netherlands1 site

  • VU medisch centrum - Afd.Interne - INT

    Amsterdam, 1081 HV

Other trials in Netherlands

Puerto Rico1 site

  • Auxilio Mutuo Cancer Center

    San Juan, 00919

Other trials in Puerto Rico

Taiwan1 site

  • Changhua Cristian Hospital

    Changhua County, 500

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
Sep 2026
First submitted
4 Mar 2013
Last updated
1 Oct 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 175 sites in 30 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 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 175 sites in United States, Russia, United Kingdom, China, Germany and 25 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 1 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in