Study on Oral Venetoclax and IV Obinutuzumab for Adults with Recurring Chronic Lymphocytic Leukemia (CLL)

Sponsor: AbbVie

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04895436

Provider View

This clinical trial is testing a combination of oral venetoclax and intravenous obinutuzumab to see if it can help control chronic lymphocytic leukemia (CLL) that has returned after previous treatment. The study will also monitor any side effects and changes in the disease.

Patient Parameters

Program Overview

Chronic lymphocytic leukemia (CLL) is a common type of blood cancer. This study aims to evaluate the effectiveness of retreatment with venetoclax and obinutuzumab in adults whose CLL has returned after initial treatment. Participants will be divided into two groups based on how long it took for their CLL symptoms to return after their first treatment. Around 75 adults will participate in this study at about 60 locations worldwide. Participants will receive a combination of intravenous obinutuzumab and oral venetoclax in 28-day cycles for a total of 6 cycles, followed by 6 to 18 cycles of venetoclax alone, depending on their group. The study will involve regular hospital or clinic visits for medical assessments, blood tests, and questionnaires to monitor the treatment's effects and any side effects.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) that needs treatment according to specific medical guidelines.
  • Previously completed a treatment regimen with venetoclax and an anti-CD20 antibody, with or without an additional drug, and achieved a response such as complete or partial remission.
  • For Cohort 1: More than 24 months have passed since the last dose of venetoclax and the return of CLL symptoms.
  • For Cohort 2: 12 to 24 months have passed since the last dose of venetoclax and the return of CLL symptoms.

Exclusion Criteria

  • Have received any other treatment for CLL after completing the previous venetoclax and anti-CD20 antibody regimen.

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