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Recruiting Phase 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)

Phase 2 – studying effectiveness and dosage
Conditions: Chronic Lymphocytic Leukemia (CLL)

Sponsor: AbbVie

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Overview
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.
Who can participate
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.
Locations 10
Australia (1)
Royal Adelaide Hospital /ID# 229898
Adelaide , South Australia
Brazil (1)
Hospital de Clinicas de Porto Alegre /ID# 243657
Porto Alegre , Rio Grande do Sul
COMPLETED
Bulgaria (1)
UMHAT Sveti Georgi EAD /ID# 272321
Plovdiv
Germany (1)
Stauferklinikum Schwaebisch Gmuend /ID# 230176
Mutlangen , Baden-Wurttemberg
Israel (1)
Hadassah /ID# 245059
Jerusalem , Jerusalem
Italy (1)
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 229504
Turin , Piedmont
Romania (1)
Fundeni Clinical Institute /ID# 241614
Bucharest , Bucharest
Spain (1)
Hospital Universitario de la Princesa /ID# 229665
Madrid
United Kingdom (1)
Blackpool Victoria Hospital /ID# 267280
Blackpool , Lancashire
United States (1)
Moores Cancer Center at UC San Diego /ID# 230157
La Jolla , California
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
28.03.2022
Completion date
01.01.2029
Registry ID
NCT04895436
Source
anzctr
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