M20-356 ReVenG
Research type
Research Study
Full title
M20-356 A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Venetoclax-Obinutuzumab Retreatment in Patients with Recurring Chronic Lymphocytic Leukemia
IRAS ID
1006777
Contact name
Aleksandra Jankielewicz
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2021-001037-39
Research summary
Chronic lymphocytic leukemia (CLL) is the most common leukaemia (cancer of blood cells). The purpose of this study is to assess how well venetoclax + obinutuzumab (VenG) works and how safe they are in adult participants with CLL who were previously treated with VenG. 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 treatment arms, based on when symptoms of CLL came back after previous treatment with VenG. Approximately 75 adult participants with CLL who have been treated with VenG 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.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
23/NW/0058
Date of REC Opinion
18 Aug 2023
REC opinion
Further Information Favourable Opinion