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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)

RecruitingPhase 2Ages 18 Years - anyAllAbbVie
NCT04895436 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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)

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📋 Eligibility rules (as published)
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.
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What it tests

  • Venetoclax
  • Obinutuzumab
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Where

58 sites
Moores Cancer Center at UC San Diego /ID# 230157
La Jolla, United States
Winship Cancer Institute of Emory University /ID# 230643
Atlanta, United States
Des Moines Oncology Research Association /ID# 232606
Des Moines, United States
Dana-Farber Cancer Institute /ID# 230061
Boston, United States
Henry Ford Hospital /ID# 230268
Detroit, United States
St. Lukes Hospital of Duluth /ID# 250021
Duluth, United States
Hattiesburg Clinic /ID# 233443
Hattiesburg, United States
Summit Medical Group-Florham Park /ID# 244782
Florham Park, United States

…and 50 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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