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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)

NCT04895436

RecruitingPhase 2

Sponsor: AbbVie

Conditions: Chronic Lymphocytic Leukemia (CLL)

Interventions: Venetoclax, Obinutuzumab

Countries: United States, Australia, Austria, Brazil, Bulgaria, Germany, Israel, Italy

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 (58)

La Jolla, California, United States
Atlanta, Georgia, United States
Des Moines, Iowa, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Duluth, Minnesota, United States
Hattiesburg, Mississippi, United States
Florham Park, New Jersey, United States
Hackensack, New Jersey, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Winston-Salem, North Carolina, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Madison, Wisconsin, United States
Adelaide, South Australia, Australia
Epping, Victoria, Australia
Melbourne, Victoria, Australia
Sankt Pölten, Lower Austria, Austria
Vienna, State of Vienna, Austria
Vienna, State of Vienna, Austria
Leoben, Styria, Austria
Linz, Upper Austria, Austria
Salzburg, Austria
Vienna, Austria
Porto Alegre, Rio Grande do Sul, Brazil
São Paulo, São Paulo, Brazil
São Paulo, Brazil
Plovdiv, Bulgaria
Vratsa, Bulgaria
+ 28 more on CT.gov