Език: EN EN
← Назад към резултатите
Активно (без набиране) Фаза 4 NCT03229200

Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.

Фаза 4 – наблюдение след одобрението на пазара
Заболявания: Lymphoma, B-Cell Lymphoma, Non-Hodgkin Leukemia, B-cell Graft Vs Host Disease Solid Tumor

Спонсор: Pharmacyclics Switzerland GmbH

Налично на: БГ
Обобщение
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.
Описание
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.
Кой може да участва
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.
Места на провеждане 17
Австралия (1)
St. George Hospital
Kogarah , New South Wales
Канада (1)
QEII Health Science Centre
Halifax , Nova Scotia
Чехия (1)
University Hospital Hradec Kralove
Hradec Králové , Hradec Králové Region
Франция (1)
CHU Hotel Dieu
Nantes , Loire Atlantique
Унгария (1)
Central Hospital of Southern Pest - National Institute of Hematology and Infectious Diseases, Dept of Hematology and Stem Cell
Budapest
Италия (1)
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan
New Zealand (1)
Middlemore Hospital
Papatoetoe , Auckland
Полша (1)
Szpital Specjalistyczny w Brzozowie, Oddział Hematologii Onkologicznej z Klinicznym Oddziałem Przeszczepiania Szpiku
Brzozów , Podkarpackie Voivodeship
Russia (1)
Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko
Nizhny Novgorod , Nizhegorodskaya
Южна Корея (1)
Kyungpook National University Hospital (KNUH)
Daegu
Испания (1)
ICO - Hospital Germans Trias I Pujol
Badalona , Barcelona
Швеция (1)
Sunderby hospital
Luleå , Norrbotten County
Taiwan (1)
China Medical University Hospital
Taichung
Турция (1)
Pamukkale University Medical Faculty
Denizli , Pamukkale
Ukraine (1)
CNE CCOHTPC of Cherkasy Regional Council
Cherkasy
Великобритания (1)
University Hospital of Wales
Cardiff
САЩ (1)
Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center, The Roy & Patricia Disney Family Cancer Center
Burbank , California
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 4
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
22.05.2017
Крайна дата
10.05.2027
Регистрационен номер
NCT03229200
Източник
anzctr
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.