Study on the Risk of Tumor Lysis Syndrome in Adults Taking Venetoclax with Obinutuzumab or Acalabrutinib for Untreated Chronic Lymphocytic Leukemia
Sponsor: AbbVie
ClinicalTrials ID:NCT06428019
This clinical trial is examining the safety of using venetoclax with either obinutuzumab or acalabrutinib to treat adults with chronic lymphocytic leukemia (CLL) who have not received treatment before. The study will monitor side effects and changes in the disease.
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Program Overview
Chronic lymphocytic leukemia (CLL) is a common type of blood cancer. This study aims to evaluate the safety of combining venetoclax with either obinutuzumab or acalabrutinib in treating CLL. Participants will be divided into four groups, each receiving different combinations and schedules of these medications. The study will involve about 120 adults with CLL across 80 locations worldwide. Participants will have regular hospital or clinic visits for medical assessments, blood tests, and to monitor side effects over approximately 28 months.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has not been treated before and requires treatment.
- Have a life expectancy of more than 6 months.
- Be in relatively good health with an ECOG performance status of 0, 1, or 2, meaning fully active or with some limitations but able to carry out light work.
- Have adequate bone marrow function without needing growth factors or transfusions, unless low blood counts are due to CLL.
- Have a creatinine clearance of at least 30 mL/min, indicating sufficient kidney function.
Exclusion Criteria
- Have an active or uncontrolled infection.
- Have a condition known as Richter's transformation.
- Have active immune thrombocytopenia.
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