Chronic Lymphocytic Leukemia Clinical Trial
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)
Chronic lymphocytic leukemia (CLL) is the most common leukemia (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.
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.
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.
- Received intervening treatment for CLL after completing previous treatment with a venetoclax + anti-CD20 antibody +/- X regimen.
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There are 43 Locations for this study
La Jolla California, 92093, United States
Des Moines Iowa, 50309, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48202, United States
Duluth Minnesota, 55805, United States
Florham Park New Jersey, 07932, United States
Charlotte North Carolina, 28204, United States
Winston-Salem North Carolina, 27103, United States
Madison Wisconsin, 53705, United States
Adelaide South Australia, 5000, Australia
Epping Victoria, 3076, Australia
Melbourne Victoria, 3000, Australia
Sankt Poelten Niederoesterreich, 3100, Austria
Linz Oberoesterreich, 4010, Austria
Vienna Wien, 1090, Austria
Vienna Wien, 1160, Austria
Salzburg , 5020, Austria
Wien , 1140, Austria
Porto Alegre Rio Grande Do Sul, 90035, Brazil
São Paulo Sao Paulo, 01409, Brazil
Sao Paulo , 01236, Brazil
Vratsa , 3000, Bulgaria
Mutlangen Baden-Wuerttemberg, 73557, Germany
Ulm Baden-Wuerttemberg, 89081, Germany
Landshut Bayern, 84036, Germany
Köln Nordrhein-Westfalen, 50937, Germany
Dresden Sachsen-Anhalt, 01307, Germany
Kiel Schleswig-Holstein, 24105, Germany
Bremen , 28239, Germany
Essen , 45147, Germany
Halle (Saale) , 06120, Germany
Hamburg , 22081, Germany
Landshut , 84034, Germany
Muenchen , 80804, Germany
Paderborn , 33098, Germany
Rostock , 18057, Germany
Haifa H_efa, 49414, Israel
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv Tel-Aviv, 64239, Israel
Jerusalem Yerushalayim, 91120, Israel
Terni , 05100, Italy
Turin , 10126, Italy
Bucharest Bucuresti, 02232, Romania
Madrid , 28006, Spain
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