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Lifeline for blood cancer patients: extended access to promising drug

NCT ID NCT03229200

Disease control Sponsor: Pharmacyclics Switzerland GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study offers continued access to ibrutinib for people with certain blood cancers or graft-versus-host disease who completed earlier ibrutinib trials and are still benefiting from the drug but cannot get it commercially. About 297 participants will receive ibrutinib while researchers track long-term safety. The goal is to keep providing treatment and gather more safety information.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

297 people

The number who actually took part.

Started

May 2017

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject must have participated in an eligible ibrutinib clinical trial, may derive clinical benefit from continued treatment or restart of treatment with ibrutinib in the opinion of the treating physician and does not have access to commercial ibrutinib within their region and/or the drug is not reasonably accessible to the patient within the respective region. * Ongoing continuous treatment with ibrutinib. * Subject must have completed all assessments in their parent protocol and want to continue treatment with ibrutinib. * Subject or their legally authorized representative must voluntarily sign and date an informed consent approved by an independent ethics committee (IEC)/institutional review board (IRB) to the long term treatment extension protocol and not withdrawn consent from the parent study. * Male and female subjects of reproductive potential who agree to use both a highly effective method of birth control and a barrier method during the period of therapy and for 90 days after the last dose of drug. Exclusion Criteria: * Meeting any requirement in the parent protocol to permanently discontinue ibrutinib treatment. * Any condition or situation which, in the opinion of the treating physician, may interfere significantly with a subject's participation in the protocol. * Female subjects who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this protocol or within 90 days of last dose of drug treatment. Male subjects who plan to father a child while enrolled in this protocol or within 90 days after the last dose of drug treatment. * Unwilling or unable to participate in all required evaluations and procedures. * Unable to understand the purpose and risks of the protocol and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information.

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Conditions

The condition(s) this trial relates to.

B-cell neoplasm graft versus host disease Leukemia, B-Cell lymphoma, non-Hodgkin, familial neoplasm non-Hodgkin lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Graft VS host disease Leukemia, B-cell Lymphoma, B-cell Lymphoma, non-Hodgkin Solid tumor

Contacts and locations

Locations

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Almazov National Medical Research Centre

    Saint Petersburg, 197341, Russia

  • Ankara Universitesi Tip Fakultesi Hastanesi

    Ankara, 06100, Turkey (Türkiye)

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, 10126, Italy

  • Azienda Ospedaliera di Padova

    Padova, 35128, Italy

  • Azienda Sanitaria Universitaria Integrata Udine

    Udine, 33100, Italy

  • Ballarat Health Services

    Ballarat, Victoria, 3350, Australia

  • CHU Hotel Dieu

    Nantes, Loire Atlantique, 44000, France

  • CNCE City Clinical Hospital 4 of Dnipro City Council

    Dnipro, 49102, Ukraine

  • CNE CCOHTPC of Cherkasy Regional Council

    Cherkasy, 18009, Ukraine

  • Central Hospital of Southern Pest - National Institute of Hematology and Infectious Diseases, Dept of Hematology and Stem Cell

    Budapest, 1097, Hungary

  • Centre Henri Becquerel

    Rouen, 76038, France

  • Centre Hospitalier Saint Brieuc

    Saint-Brieuc, 22000, France

  • Charles University Hospital, Prague

    Prague, 12808, Czechia

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • City Of Hope National Medical Center

    Duarte, California, 91010, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Concord Repatriation General Hospital - Haematology Clinical Trials

    Sydney, New South Wales, 2139, Australia

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dokuz Eylul University

    Izmir, 35340, Turkey (Türkiye)

  • Eastern Health

    Box Hill, Victoria, 3128, Australia

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34, Czechia

  • Flinders Medical Centre

    Bedford Park, South Australia, 5067, Australia

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    Pavia, 27100, Italy

  • Gazi University

    Ankara, 06500, Turkey (Türkiye)

  • Hematology and Oncology Masaryk University Hospital Brno

    Brno, 62500, Czechia

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222, Spain

  • Hospital Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital de Sanata Creus i Sant Pau

    Barcelona, 08041, Spain

  • ICO - Hospital Germans Trias I Pujol

    Badalona, Barcelona, 08916, Spain

  • ICO l'Hospitalet - Hospital Duran i Reynals

    Barcelona, 08908, Spain

  • John Theurer Cancer Center, Hackensack UMC

    Hackensack, New Jersey, 07601, United States

  • Karolinska Universitetssjukhuset, Solna

    Solna, 171 76, Sweden

  • Klinika Hematologii i Transplantologii

    Gdansk, Pomeranian Voivodeship, 80-211, Poland

  • Kyungpook National University Hospital (KNUH)

    Daegu, 41944, South Korea

  • Leeds Teaching Hospitals NHS

    Leeds, LS9 7TF, United Kingdom

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • M.D. Anderson Cancer Centre

    Houston, Texas, 77030, United States

  • McGill University Health Center

    Montreal, Quebec, H4A3J1, Canada

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065-6007, United States

  • Mid Ohio Oncology/Hematology Inc., DBA The Mark H. Zangmeister Center

    Columbus, Ohio, 43219, United States

  • Middlemore Hospital

    Papatoetoe, Auckland, 2025, New Zealand

  • Monash Health-Monash Medical Centre

    Clayton, Victoria, 3168, Australia

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko

    Nizhny Novgorod, Nizhegorodskaya, 603126, Russia

  • North Shore Hospital

    Auckland, 0622, New Zealand

  • Northwell Health

    New Hyde Park, New York, 11042, United States

  • Northwest Cancer Specialists, Compass Oncology

    Vancouver, Washington, 09868, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Norton Medical Plaza II, 3991 Dutchmans Lane

    Louisville, Kentucky, 40207, United States

  • Ospedale San Raffaele IRCCS

    Milan, 20132, Italy

  • Pamukkale University Medical Faculty

    Denizli, Pamukkale, 20070, Turkey (Türkiye)

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G2M9, Canada

  • Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center, The Roy & Patricia Disney Family Cancer Center

    Burbank, California, 91505, United States

  • QEII Health Science Centre

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medical Biological Agency

    Saint Petersburg, 191024, Russia

  • SBI of Ryazan region "Regional Clinical Hospital"

    Ryazan, Ryazan Oblast, 390039, Russia

  • SI Institute of Blood Pathology and Transfusion Medicine of AMSU

    Lviv, 79044, Ukraine

  • SPZOZ ZSM w Chorzowie

    Chorzów, Silesian Voivodeship, 41-500, Poland

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401, United States

  • Southeastern Medical Oncology Center

    Goldsboro, North Carolina, 27534-9479, United States

  • St Vincent Hospital

    Fitzroy, Victoria, 3065, Australia

  • St. George Hospital

    Kogarah, New South Wales, 2217, Australia

  • Stanford University

    Stanford, California, 94305, United States

  • Sunderby hospital

    Luleå, Norrbotten County, 97180, Sweden

  • Swedish Cancer Institute

    Seattle, Washington, 98104, United States

  • Szpital Specjalistyczny w Brzozowie, Oddział Hematologii Onkologicznej z Klinicznym Oddziałem Przeszczepiania Szpiku

    Brzozów, Podkarpackie Voivodeship, 36-200, Poland

  • Södra Älvsborg Hospital Borås

    Borås, 50182, Sweden

  • TRIO - Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169-3321, United States

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • UCSD Moores Cancer Center

    La Jolla, California, 92093-0698, United States

  • US Oncology Research, LLC

    The Woodlands, Texas, 77380, United States

  • University College Hospitals NHS Foundation Trust

    London, NW1 2PG, United Kingdom

  • University Hospital Hradec Kralove

    Hradec Králové, Hradec Králové Region, 50005, Czechia

  • University Hospital Pilsen

    Pilsen, 30460, Czechia

  • University Hospital of Salamanca

    Salamanca, 37007, Spain

  • University Hospital of Wales

    Cardiff, CF14 4XW, United Kingdom

  • University of California Los Angeles (UCLA)

    Los Angeles, California, 90095, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267, United States

  • University of Pennsylvania Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030-4009, United States

  • University of Vermont Medical Center

    Burlington, Vermont, 05405, United States

  • VKV American Hospital

    Istanbul, 34365, Turkey (Türkiye)

  • Vanderbilt Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

  • Weill Cornell Medical College-New York Presbyterian Hospital

    New York, New York, 10065, United States

  • Wenatchee Valley Hospital and Clinics

    Wenatchee, Washington, 98801, United States

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika

    Lodz, 93-510, Poland

  • Yakima Valley Memorial Hospital

    Yakima, Washington, 98902, United States

  • Yaroslavl Regional Clinical Hospital

    Yaroslavl, 150062, Russia

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