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Набира участници Фаза 2 NCT04895436

Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Chronic Lymphocytic Leukemia (CLL)

Спонсор: AbbVie

Налично на: БГ
Обобщение
Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess retreatment with venetoclax-obinutuzumab (VenG) in participants previously treated with fixed duration first-line (IL) therapy of venetoclax in combination with an anti-CD20 antibody +/- X (where X is any additional drug). Adverse events and change in disease activity will be assessed. Venetoclax is an approved drug for the treatment of CLL. Study doctors put the participants in 1 of 2 groups, called cohorts, based on when symptoms of CLL came back after previous treatment in first-line. Approximately 75 adult participants with CLL who have been treated with venetoclax in combination with an anti-CD20 antibody +/- X will be enrolled in the study in approximately 60 sites worldwide. Participants will receive intravenous (IV) obinutuzumab + oral venetoclax (VenG) in 28-day cycles for a total of 6 cycles per cohort, followed by 6 to 18 cycles of venetoclax alone, for a total treatment of 12 to 24 cycles, depending on the cohort. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Кой може да участва
Inclusion Criteria: * Documented diagnosis of chronic lymphocytic leukemia (CLL) that requires treatment for CLL according to International Workshop for Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria. * Previously completed venetoclax + anti-CD20 antibody +/- X regimen as a fixed duration first-line (1L) therapy and achieved documented response, defined as complete remission, complete remission with incomplete marrow recovery, partial remission, or nodular partial remission. * More than 24 months (Cohort 1) or 12-24 months (Cohort 2) have elapsed between last dose of venetoclax and disease progression after completion of 1L treatment. Exclusion Criteria: \- Received intervening treatment for CLL after completing previous treatment with a venetoclax + anti-CD20 antibody +/- X regimen.
Места на провеждане 10
Австралия (1)
Royal Adelaide Hospital /ID# 229898
Adelaide , South Australia
Бразилия (1)
Hospital de Clinicas de Porto Alegre /ID# 243657
Porto Alegre , Rio Grande do Sul
COMPLETED
България (1)
UMHAT Sveti Georgi EAD /ID# 272321
Plovdiv
Германия (1)
Stauferklinikum Schwaebisch Gmuend /ID# 230176
Mutlangen , Baden-Wurttemberg
Израел (1)
Hadassah /ID# 245059
Jerusalem , Jerusalem
Италия (1)
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 229504
Turin , Piedmont
Румъния (1)
Fundeni Clinical Institute /ID# 241614
Bucharest , Bucharest
Испания (1)
Hospital Universitario de la Princesa /ID# 229665
Madrid
Великобритания (1)
Blackpool Victoria Hospital /ID# 267280
Blackpool , Lancashire
САЩ (1)
Moores Cancer Center at UC San Diego /ID# 230157
La Jolla , California
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
28.03.2022
Крайна дата
01.01.2029
Регистрационен номер
NCT04895436
Източник
anzctr
Запитване за медицински туризъм

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