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Активно (без набиране) Фаза 2 NCT05201066

Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab.

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Myelodysplastic Syndromes Leukemia, Myelomonocytic, Chronic

Спонсор: Novartis Pharmaceuticals

Налично на: БГ
Обобщение
This study is intended to collect safety data from participants who completed the parent protocols but are still benefiting from study treatment. The study population consists of participants who tolerate study treatment of the parent studies. Collecting safety information from long-term exposure might offer the unique opportunity to detect rare Adverse Events.
Описание
This is a multicenter, open label, roll-over study to collect and assess safety of sabatolimab in participants who are treated in current Novartis-sponsored parent studies and who are benefiting from continued study treatment including sabatolimab as judged by the investigator. There is no conventional screening period in this study as participants are expected to transition directly from treatment on the parent protocol to treatment on this roll-over protocol. Participants who are candidates for the roll-over protocol will be evaluated by the investigator in the parent protocol for eligibility for the roll-over protocol. If eligible, the parent protocol end of treatment visit will be performed and the informed consent for the roll-over protocol will be signed. Participants then continue treatment on this protocol with the next planned dose of sabatolimab as monotherapy or with other combination agent(s). The treatment with sabatolimab and combination agent(s), as applicable, is continued according to the schedule in the parent study. Adverse events (AEs) will be collected continuously throughout the study and participants will be questioned about adverse events at each visit.
Кой може да участва
Inclusion Criteria: 1. Participant is currently enrolled in a Novartis-sponsored study with sabatolimab, is being treated with sabatolimab, and has fulfilled all requirements in the parent study. 2. Participant is currently benefiting from the treatment with sabatolimab as determined by guidelines of the parent protocol and investigator's judgment. 3. Participant has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements. 4. Willingness and ability to comply with scheduled visits, treatment plan and any other study procedures. 5. Written informed consent obtained prior to enrolling in the roll-over study. Exclusion Criteria: 1. Participants in cohorts or treatment groups not receiving sabatolimab in the parent protocol. 2. Participant has been permanently discontinued from sabatolimab treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason. 3. Participant currently has unresolved toxicities for which sabatolimab dosing has been interrupted in the parent study (participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow sabatolimab dosing to resume). 4. Pregnant or nursing (lactating) women. Where pregnancy is defined as the state of a female after conception confirmed by a positive serum hCG laboratory test and until the termination of gestation. 5. Participant not willing to comply with the contraception requirements outlined in the exclusion criteria of the parent protocol. 6. Local access to commercially available sabatolimab for parent protocol indications. Other protocol-defined Inclusion/Exclusion may apply.
Места на провеждане 15
Австралия (1)
Novartis Investigative Site
Clayton , Victoria
Бразилия (1)
Novartis Investigative Site
Florianópolis , Santa Catarina
Канада (1)
Novartis Investigative Site
Vancouver , British Columbia
Китай (1)
Novartis Investigative Site
Changchun , Jilin
Чехия (1)
Novartis Investigative Site
Prague
Франция (1)
Novartis Investigative Site
Toulouse
Германия (1)
Novartis Investigative Site
Freiburg im Breisgau , Baden-Wurttemberg
Гърция (1)
Novartis Investigative Site
Alexandroupoli
Италия (1)
Novartis Investigative Site
Brescia , BS
Япония (1)
Novartis Investigative Site
Fukushima
Malaysia (1)
Novartis Investigative Site
Kuala Lumpur
Испания (1)
Novartis Investigative Site
Badalona , Barcelona
Швейцария (1)
Novartis Investigative Site
Zurich
Турция (1)
Novartis Investigative Site
Izmir
САЩ (1)
Oregon Health Sciences University
Portland , Oregon
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
12 Years
Максимална възраст
99 Years
Здрави доброволци
Не
Начална дата
13.02.2023
Крайна дата
14.02.2028
Регистрационен номер
NCT05201066
Източник
anzctr
Запитване за медицински туризъм

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