Clinical Trial TitleIbrutinib and obinutuzumab with or without venetoclax in treating patients with chronic lymphocytic leukemia.
National Clinical Trial Number:NCT03701282
Clinical Trial Protocol Description:
This study is accepting patients at both Rush University Medical Center and Rush Copley Medical Center. Please see contact information below to join the study at one location.
Leukemia is a cancer of the marrow and blood. Leukemia is called “lymphocytic” or “lymphoblastic” if the cancerous change takes place in a type of marrow cell that form lymphocytes, a type of white blood cell. CLL results from an acquired mutation to the DNA of a single marrow cell that develops into a lymphocyte.
This study is focusing on patients between the ages of 18 and 70. The purpose of this study is to compare the usual treatment of ibrutinib and obinutuzumab to a combination treatment of ibrutinib and obinutuzumab plus the study drug, venetoclax. The addition of venetoclax to the usual treatment may or may not help shrink a subject’s cancer. But, it could also cause more side effects. This study will also compare the usual treatment of indefinite ibrutinib therapy to a time limited therapy schedule of approximately 18 months to better understand the effects on subject’s quality of life and the cost of care. This study will help the study doctors find out if these different approaches are equally effective to the usual approaches while requiring a shorter duration of treatment.
Ibrutinib, obinutuzumab, and venetoclax are all FDA approved drugs to treat CLL, but they will be considered investigational in the setting of this trial.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older, but younger than 70 years of age.
- Have CLL.
- Have not received prior chemotherapy, BTK inhibitor therapy, venetoclax, or monoclonal antibody therapy for CLL.
- Are able to swallow pills.
You will be excluded from the study if any of the following criteria apply to you:
- Have a medical condition such as an uncontrolled infection (including HIV), uncontrolled diabetes mellitus, or cardiac disease.
- Take more than 20 milligrams of prednisone or equivalent corticosteroid daily.
- Have had major surgery within 4 weeks of the first dose of study drug, or minor surgery within 3 days of starting study drug.
This is a partial list of inclusion and exclusion criteria.