Lymphoma, B-CellPhase 4NCT03229200
Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.
A Phase 4 study testing Ibrutinib in people with Lymphoma, B-Cell and Lymphoma, Non-Hodgkin, run by Pharmacyclics Switzerland GmbH at 98 sites in 17 countries.
Trial summary
Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Leukemia, B-cell
- What is being tested?
- Ibrutinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 297 participants
- Where
- 98 sitesin 17 countries
- Study dates
- 22 May 2017to 10 May 2027
- Phase
- Phase 4
- 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
- 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ethics committee (IEC)/institutional review board (IRB) to the long term treatment extension protocol and not withdrawn consent from the parent study.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.
Who cannot join
- 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.
Trial locations and contacts
98 sites in 17 countries.
98 sites in 17 countries
United States34 sites
Emory University
Atlanta, Georgia, 30322
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
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
University of Vermont Medical Center
Burlington, Vermont, 05405
Levine Cancer Institute
Charlotte, North Carolina, 28204
Northwestern University
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University
Columbus, Ohio, 43210
Mid Ohio Oncology/Hematology Inc., DBA The Mark H. Zangmeister Center
Columbus, Ohio, 43219
Henry Ford Health System
Detroit, Michigan, 48202
City Of Hope National Medical Center
Duarte, California, 91010
San Juan Oncology Associates
Farmington, New Mexico, 87401
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27534-9479
John Theurer Cancer Center, Hackensack UMC
Hackensack, New Jersey, 07601
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009
M.D. Anderson Cancer Centre
Houston, Texas, 77030
UCSD Moores Cancer Center
La Jolla, California, 92093-0698
TRIO - Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169-3321
University of California Los Angeles (UCLA)
Los Angeles, California, 90095
Norton Medical Plaza II, 3991 Dutchmans Lane
Louisville, Kentucky, 40207
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37232
Northwell Health
New Hyde Park, New York, 11042
Memorial Sloan Kettering Cancer Center
New York, New York, 10065-6007
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, 10065
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
University of Rochester
Rochester, New York, 14642
Swedish Cancer Institute
Seattle, Washington, 98104
Stanford University
Stanford, California, 94305
US Oncology Research, LLC
The Woodlands, Texas, 77380
Northwest Cancer Specialists, Compass Oncology
Vancouver, Washington, 09868
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, 98801
Yakima Valley Memorial Hospital
Yakima, Washington, 98902
Australia9 sites
Ballarat Health Services
Ballarat, Victoria, 3350
Flinders Medical Centre
Bedford Park, South Australia, 5067
Eastern Health
Box Hill, Victoria, 3128
Monash Health-Monash Medical Centre
Clayton, Victoria, 3168
St Vincent Hospital
Fitzroy, Victoria, 3065
St. George Hospital
Kogarah, New South Wales, 2217
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Concord Repatriation General Hospital - Haematology Clinical Trials
Sydney, New South Wales, 2139
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Italy7 sites
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, 20122
Ospedale San Raffaele IRCCS
Milan, 20132
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
Azienda Ospedaliera di Padova
Padova, 35128
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, 27100
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, 10126
Azienda Sanitaria Universitaria Integrata Udine
Udine, 33100
Spain7 sites
ICO - Hospital Germans Trias I Pujol
Badalona, Barcelona, 08916
Hospital Vall d'Hebron
Barcelona, 08035
Hospital de Sanata Creus i Sant Pau
Barcelona, 08041
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, 08908
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
University Hospital of Salamanca
Salamanca, 37007
Czechia5 sites
Hematology and Oncology Masaryk University Hospital Brno
Brno, 62500
University Hospital Hradec Kralove
Hradec Králové, Hradec Králové Region, 50005
University Hospital Pilsen
Pilsen, 30460
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34
Charles University Hospital, Prague
Prague, 12808
Russia5 sites
Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko
Nizhny Novgorod, Nizhegorodskaya, 603126
SBI of Ryazan region "Regional Clinical Hospital"
Ryazan, Ryazan Oblast, 390039
Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medical Biological Agency
Saint Petersburg, 191024
Almazov National Medical Research Centre
Saint Petersburg, 197341
Yaroslavl Regional Clinical Hospital
Yaroslavl, 150062
Turkey (Türkiye)5 sites
Ankara Universitesi Tip Fakultesi Hastanesi
Ankara, 06100
Gazi University
Ankara, 06500
Pamukkale University Medical Faculty
Denizli, Pamukkale, 20070
VKV American Hospital
Istanbul, 34365
Dokuz Eylul University
Izmir, 35340
Poland4 sites
Szpital Specjalistyczny w Brzozowie, Oddział Hematologii Onkologicznej z Klinicznym Oddziałem Przeszczepiania Szpiku
Brzozów, Podkarpackie Voivodeship, 36-200
SPZOZ ZSM w Chorzowie
Chorzów, Silesian Voivodeship, 41-500
Klinika Hematologii i Transplantologii
Gdansk, Pomeranian Voivodeship, 80-211
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika
Lodz, 93-510
United Kingdom4 sites
University Hospital of Wales
Cardiff, CF14 4XW
Leeds Teaching Hospitals NHS
Leeds, LS9 7TF
University College Hospitals NHS Foundation Trust
London, NW1 2PG
The Christie NHS Foundation Trust
Manchester, M20 4BX
Canada3 sites
QEII Health Science Centre
Halifax, Nova Scotia, B3H 2Y9
McGill University Health Center
Montreal, Quebec, H4A3J1
Princess Margaret Cancer Centre
Toronto, Ontario, M5G2M9
France3 sites
CHU Hotel Dieu
Nantes, Loire Atlantique, 44000
Centre Henri Becquerel
Rouen, 76038
Centre Hospitalier Saint Brieuc
Saint-Brieuc, 22000
Sweden3 sites
Södra Älvsborg Hospital Borås
Borås, 50182
Sunderby hospital
Luleå, Norrbotten County, 97180
Karolinska Universitetssjukhuset, Solna
Solna, 171 76
Ukraine3 sites
CNE CCOHTPC of Cherkasy Regional Council
Cherkasy, 18009
CNCE City Clinical Hospital 4 of Dnipro City Council
Dnipro, 49102
SI Institute of Blood Pathology and Transfusion Medicine of AMSU
Lviv, 79044
New Zealand2 sites
North Shore Hospital
Auckland, 0622
Middlemore Hospital
Papatoetoe, Auckland, 2025
Taiwan2 sites
China Medical University Hospital
Taichung, 40447
National Taiwan University Hospital
Taipei, 100
Hungary1 site
Central Hospital of Southern Pest - National Institute of Hematology and Infectious Diseases, Dept of Hematology and Stem Cell
Budapest, 1097
South Korea1 site
Kyungpook National University Hospital (KNUH)
Daegu, 41944
About this study
Official title: Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib After Completion of Ibrutinib Clinical Trials.
Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region.
Read the detailed description
Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region.
Subjects enrolled in this treatment protocol will receive oral continuous dosing with ibrutinib at the same dose and schedule they were receiving at the end of the respective parent study. Treatment may be continued as long as the subjects continue to derive benefit from treatment with ibrutinib until such time that ibrutinib becomes commercially available for the indication of the parent study.
Clinical evaluations (including safety assessments) will be performed per local standard of care for each disease that was studied in the parent protocol. At each visit, all ongoing and new onset non-serious AEs leading to dose reduction or discontinuation, serious adverse events (SAEs), adverse events of special interest (AESI), pregnancy events, other malignancies, and special reporting situations will be recorded.
- Conditions
- Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Leukemia, B-cell, Graft Vs Host Disease, Solid Tumor
- Being tested
- Ibrutinib
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Leukemia, B-Cell, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrutinibDrug
Subjects will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study.
| Study group | Role | What they receive |
|---|---|---|
| Ibrutinib | Experimental | Treatment with Ibrutinib, once daily until disease progression or unacceptable toxicity. Receives: Drug: Ibrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the drug safety profile by collecting long-term safety data for ibrutinib.
Number of participants with treatment emergent serious adverse events and adverse events of special interest as assessed by CTCAE v4.0.
Measured: Up to 3 years and will be re-evaluated on an ongoing basis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start22 May 2017
- Primary completion10 May 2027 (estimated)
- Study completion10 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, B-CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmacyclics Switzerland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Biotech, Inc., including Johnson & Johnson
- Responsible party
- Sponsor
- Investigators
- Kevin Wu, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229200
- Sponsor's protocol ID
- PCYC-1145-LT
- Other IDs
- 2016-004356-30, 2016
- Status last verified
- Oct 2025
- First submitted
- 5 Jun 2017
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib After Completion of Ibrutinib Clinical Trials.
- ClinicalTrials.gov ID
- NCT03229200
- Acronym / sponsor ID
- PCYC-1145-LT
- Conditions
- Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Leukemia, B-cell, Graft Vs Host Disease, Solid Tumor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Pharmacyclics Switzerland GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Biotech, Inc., including Johnson & Johnson
- Study start
- 22 May 2017 (actual)
- Primary completion
- 10 May 2027 (estimated)
- Study completion
- 10 May 2027 (estimated)
- First posted
- 25 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region.
Detailed description
Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region.
Subjects enrolled in this treatment protocol will receive oral continuous dosing with ibrutinib at the same dose and schedule they were receiving at the end of the respective parent study. Treatment may be continued as long as the subjects continue to derive benefit from treatment with ibrutinib until such time that ibrutinib becomes commercially available for the indication of the parent study.
Clinical evaluations (including safety assessments) will be performed per local standard of care for each disease that was studied in the parent protocol. At each visit, all ongoing and new onset non-serious AEs leading to dose reduction or discontinuation, serious adverse events (SAEs), adverse events of special interest (AESI), pregnancy events, other malignancies, and special reporting situations will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ibrutinib | Experimental | Drug: IbrutinibTreatment with Ibrutinib, once daily until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbrutinibSubjects will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study. | Drug | Ibrutinib |
Primary outcome
Characterize the drug safety profile by collecting long-term safety data for ibrutinib.
Time frame: Up to 3 years and will be re-evaluated on an ongoing basis.
Number of participants with treatment emergent serious adverse events and adverse events of special interest as assessed by CTCAE v4.0.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Wu study director
AbbVie
98 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibrutinib in people with Lymphoma, B-Cell and Lymphoma, Non-Hodgkin, run by Pharmacyclics Switzerland GmbH at 98 sites in 17 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 5 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 98 sites in United States, Australia, Italy, Spain, Czechia and 12 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Characterize the drug safety profile by collecting long-term safety data for ibrutinib. (time frame: Up to 3 years and will be re-evaluated on an ongoing basis.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2025.