UPCC 14425 A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Venetoclax-Obinutuzumab Retreatment in Patients with Recurring Chronic Lymphocytic Leukemia (ReVenG)
Retreatment Study for Chronic Lymphocytic Leukemia
Brief description of study
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Chronic Lymphocytic Leukemia (CLL)
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Age: 18 years or above
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Gender: All
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.
The purpose of this study is to assess the retreatment of chronic lymphocytic leukemia (CLL) using a combination of investigational medications. Participants in this study have previously been treated with a specific therapy involving an anti-CD20 antibody and are now being evaluated for retreatment. The study will look into how effective the retreatment is and monitor any side effects.
Participants will be divided into two groups based on when their CLL symptoms returned after their initial treatment. They will receive a combination of intravenous medication and oral medication in 28-day cycles. Depending on their group, participants will undergo between 12 to 24 cycles of treatment. Throughout the study, participants will have regular visits to the hospital or clinic for medical assessments, blood tests, side effect monitoring, and to complete questionnaires.
- Who can participate: Adults with chronic lymphocytic leukemia who completed a specific treatment and had symptoms return after 12 to 24 months can participate.
- Study details: Participants will receive intravenous and oral investigational medications in cycles, with regular visits for assessments and monitoring.
Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.
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