Clinical trial • Phase IV • Oncology
IBRUTINIB for Follicular lymphoma|Chronic lymphocytic leukemia|Waldenstrom macroglobulinemia|Multiple myeloma|Marginal zone lymphoma|Diffuse large B-cell lymphoma|Urothelial carcinoma|Breast cancer|Acute myeloid leukemia|Graft versus host disease|Mantle cell lymphoma
Phase IV trial of IBRUTINIB for Follicular lymphoma|Chronic lymphocytic leukemia|Waldenstrom macroglobulinemia|Multiple myeloma|Marginal zone lymphoma|Dif…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Follicular lymphoma|Chronic lymphocytic leukemia|Waldenstrom macroglobulinemia|Multiple myeloma|Marginal zone lymphoma|Diffuse large B-cell lymphoma|Urothelial carcinoma|Breast cancer|Acute myeloid leukemia|Graft versus host disease|Mantle cell lymphoma
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 31-07-2024
- First CTIS Authorization Date
- 16-08-2024
Trial design
None/Not specified-controlled Phase IV trial in Sweden, Czechia, Hungary and others.
- Comparator
- None/Not specified
- Target Sample Size
- 495
Eligibility
Recruits 495 Includes vulnerable adults: adults under legal protection measures (e.g., guardianship/curatorship) and certain adults receiving psychiatric care. Participants must not be incarcerated. The subject or their legally authorised representative must voluntarily sign and date an informed consent form approved by an independent ethics committee (IEC)/institutional review board (IRB). Investigator discretion should be applied for those under legal protection or unable to express consent..
- Pregnancy Exclusion
- 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
- Vulnerable Population
- Includes vulnerable adults: adults under legal protection measures (e.g., guardianship/curatorship) and certain adults receiving psychiatric care. Participants must not be incarcerated. The subject or their legally authorised representative must voluntarily sign and date an informed consent form approved by an independent ethics committee (IEC)/institutional review board (IRB). Investigator discretion should be applied for those under legal protection or unable to express consent.
Inclusion criteria
- {"criterion_text":"- 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\n- Ongoing continuous treatment with ibrutinib\n- Subject must have completed all assessments in their parent protocol and want to continue treatment with ibrutinib.\n- 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\n- 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 for females and males after the last dose of drug\n- Subjects must not be incarcerated and must be freely willing and able to provide informed consent (e.g., adults under legal protection measure [e.g., under guardianship/curatorship] or unable to express their consent and select adults under psychiatric care). Investigator discretion should be applied."}
Exclusion criteria
- {"criterion_text":"- Meeting any requirement in the parent protocol to permanently discontinue ibrutinib treatment\n- Any condition or situation which, in the opinion of the treating physician, may interfere significantly with a subject’s participation in the protocol\n- 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\n- Unwilling or unable to participate in all required evaluations and procedures\n- 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"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Assessment of percentage of patients rolling over from each parent study","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Number of participants with treatment emergent serious adverse events and adverse events of special interest as assessed by CTCAE v4.0.","definition_or_measurement_approach":"Assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.0"}
Recruitment
- Planned Sample Size
- 495
- Recruitment Window Months
- 121
- Consent Approach
- Subjects or their legally authorised representative must voluntarily sign and date an informed consent form approved by an independent ethics committee (IEC)/institutional review board (IRB) for the long-term extension protocol. Consent is adult-focused (no paediatric assent specified). Country-specific ICFs and subject information materials are provided in multiple languages (examples in document list include ENG, FRA, ITA, ESP, POL, HUN, SWE, CZE).
Geography
- Total Number Of Sites
- 19
- Total Number Of Participants
- 125
Sweden
- Earliest CTIS Part Ii Submission Date
- 12-06-2024
- Latest Decision Or Authorization Date
- 18-09-2025
- Processing Time Days
- 463
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Soedra Aelvsborg Hospital Vaestra Goetalandsregionen
- Department Name
- Rheumatology
- Principal Investigator Name
- Per Ola Andersson
- Principal Investigator Email
- per-ola.andersson@vgregion.se
- Contact Person Name
- Per Ola Andersson
- Contact Person Email
- per-ola.andersson@vgregion.se
Czechia
- Earliest CTIS Part Ii Submission Date
- 15-07-2024
- Latest Decision Or Authorization Date
- 17-09-2025
- Processing Time Days
- 429
- Number Of Sites
- 3
- Number Of Participants
- 18
Sites
- Site Name
- Fakultni Nemocnice Kralovske Vinohrady
- Department Name
- Oddeleni klinicke hematologie
- Principal Investigator Name
- Jan Novák
- Principal Investigator Email
- jan.novak@fnkv.cz
- Contact Person Name
- Jan Novák
- Contact Person Email
- jan.novak@fnkv.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- IV. interní hematologická klinika
- Principal Investigator Name
- Jiří Mayer
- Principal Investigator Email
- martin.simkovic@fnhk.cz
- Contact Person Name
- Jiří Mayer
- Contact Person Email
- martin.simkovic@fnhk.cz
- Site Name
- Fakultni Nemocnice Plzen
- Department Name
- Hematologicko-onkologické oddělení
- Principal Investigator Name
- Pavel Jindra
- Principal Investigator Email
- jindra@fnplzen.cz
- Contact Person Name
- Pavel Jindra
- Contact Person Email
- jindra@fnplzen.cz
Hungary
- Earliest CTIS Part Ii Submission Date
- 15-07-2024
- Latest Decision Or Authorization Date
- 21-10-2025
- Processing Time Days
- 463
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
- Department Name
- Hematologiai es Ossejt-transzplantacios Osztaly
- Principal Investigator Name
- Laszlo Gopcsa
- Principal Investigator Email
- laszlogopcsa@yahoo.com
- Contact Person Name
- Laszlo Gopcsa
- Contact Person Email
- laszlogopcsa@yahoo.com
Poland
- Earliest CTIS Part Ii Submission Date
- 15-07-2024
- Latest Decision Or Authorization Date
- 19-09-2025
- Processing Time Days
- 431
- Number Of Sites
- 3
- Number Of Participants
- 20
Sites
- Site Name
- Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
- Department Name
- Oddział Hematologii Onkologicznej z Pododdziałem Transplantologii Klinicznej
- Principal Investigator Name
- Jacek Krzanowski
- Principal Investigator Email
- jacek.krzanowski@gmail.com
- Contact Person Name
- Jacek Krzanowski
- Contact Person Email
- jacek.krzanowski@gmail.com
- Site Name
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
- Department Name
- Oddział Hematologii
- Principal Investigator Name
- Tadeusz Robak
- Principal Investigator Email
- robaktad@csk.umed.lodz.pl
- Contact Person Name
- Tadeusz Robak
- Contact Person Email
- robaktad@csk.umed.lodz.pl
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
- Department Name
- Oddział Hematologiczny
- Principal Investigator Name
- Marcin Fejklowicz
- Principal Investigator Email
- badania_kliniczne@zsm.com.pl
- Contact Person Name
- Marcin Fejklowicz
- Contact Person Email
- badania_kliniczne@zsm.com.pl
Spain
- Earliest CTIS Part Ii Submission Date
- 12-06-2024
- Latest Decision Or Authorization Date
- 20-10-2025
- Processing Time Days
- 495
- Number Of Sites
- 4
- Number Of Participants
- 40
Sites
- Site Name
- Institut Catala D'oncologia
- Department Name
- Hematology sercive
- Principal Investigator Name
- Eva Gonzalez Barca
- Principal Investigator Email
- e.gonzalez@iconcologia.net
- Contact Person Name
- Eva Gonzalez Barca
- Contact Person Email
- e.gonzalez@iconcologia.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Hematology sercive
- Principal Investigator Name
- Javier de la Serna Torroba
- Principal Investigator Email
- drjdelaserna@gmail.com
- Contact Person Name
- Javier de la Serna Torroba
- Contact Person Email
- drjdelaserna@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Hematology Department
- Principal Investigator Name
- Francesc Bosch Albareda
- Principal Investigator Email
- fboschct@vhio.net
- Contact Person Name
- Francesc Bosch Albareda
- Contact Person Email
- fboschct@vhio.net
- Site Name
- University Of Valladolid
- Department Name
- Hematology
- Principal Investigator Name
- María Jesús Peñarrubia Ponce
- Principal Investigator Email
- mpenarrubia@saludcastillayleon.es
- Contact Person Name
- María Jesús Peñarrubia Ponce
- Contact Person Email
- mpenarrubia@saludcastillayleon.es
France
- Earliest CTIS Part Ii Submission Date
- 12-06-2024
- Latest Decision Or Authorization Date
- 17-09-2025
- Processing Time Days
- 462
- Number Of Sites
- 1
- Number Of Participants
- 30
Sites
- Site Name
- Hospital Hotel Dieu
- Department Name
- Hématologie
- Principal Investigator Name
- Chloé ANTIER
- Principal Investigator Email
- chloe.antier@chu-nantes.fr
- Contact Person Name
- Chloé ANTIER
- Contact Person Email
- chloe.antier@chu-nantes.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 12-06-2024
- Latest Decision Or Authorization Date
- 09-10-2025
- Processing Time Days
- 484
- Number Of Sites
- 6
- Number Of Participants
- 10
Sites
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Ematologia I
- Principal Investigator Name
- Michele Merli
- Principal Investigator Email
- michele.merli@policlinico.mi.it
- Contact Person Name
- Michele Merli
- Contact Person Email
- michele.merli@policlinico.mi.it
- Site Name
- Azienda Ospedaliera di Padova
- Department Name
- Dipartimento di Medicina Clinica e Sperimentale
- Principal Investigator Name
- Livio Trentin
- Principal Investigator Email
- livio.trentin@unipd.it
- Contact Person Name
- Livio Trentin
- Contact Person Email
- livio.trentin@unipd.it
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- Clinica di Ematologia
- Principal Investigator Name
- Marzia Varettoni
- Principal Investigator Email
- m.varettoni@smatteo.pv.it
- Contact Person Name
- Marzia Varettoni
- Contact Person Email
- m.varettoni@smatteo.pv.it
- Site Name
- Azienda Sanitaria Universitaria Friuli Centrale
- Department Name
- Clinica Ematologica
- Principal Investigator Name
- Jacopo Olivieri
- Principal Investigator Email
- jacopo.olivieri@asufc.sanita.fvg.it
- Contact Person Name
- Jacopo Olivieri
- Contact Person Email
- jacopo.olivieri@asufc.sanita.fvg.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Department Name
- Ematologia
- Principal Investigator Name
- Ilaria Dr. Del Giudice,
- Principal Investigator Email
- Ilaria.delgiudice@uniroma1.it
- Contact Person Name
- Ilaria Dr. Del Giudice,
- Contact Person Email
- Ilaria.delgiudice@uniroma1.it
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- UO Clinica Ematologica
- Principal Investigator Name
- Roberto Massimo Lemoli
- Principal Investigator Email
- roberto.lemoli@unige.it
- Contact Person Name
- Roberto Massimo Lemoli
- Contact Person Email
- roberto.lemoli@unige.it
Sponsor
Primary sponsor
- Full Name
- AbbVie Deutschland GmbH & Co. KG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- Suvoda LLC
- Responsibilities
- [14,3]
- Name
- IQVIA Limited
- Responsibilities
- [1,12,2,7]
- Name
- Sitero LLC
- Responsibilities
- [6]
Third parties
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"[14,3]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"[1,12,2,7]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Sitero LLC","duties_or_roles":"[6]","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Ibrutinib
- Active Substance
- IBRUTINIB
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised
- Maximum Dose
- 840 mg
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer
- Abemaciclib for Stage IV lung cancer | Breast cancer
- BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
- AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer
- Pembrolizumab for Classical Hodgkin lymphoma | Melanoma | Solid tumours (MSI-H/dMMR) | Solid tumours (TMB-H)