Clinical Trial TitleIbrutinib and obinutuzumab with or without venetoclax in treating older patients with untreated chronic lymphocytic leukemia.
National Clinical Trial Number:NCT03737981
Clinical Trial Protocol Description:
This study is accepting patients at both Rush University Medical Center and Rush Copley Medical Center. Please see contact information to join the study at one location.
Leukemia is a cancer of the marrow and blood. The four major types of leukemia are chronic lymphocytic leukemia (CLL), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), and acute myeloid leukemia (AML). 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 70 years of age and older. The purpose of this study is to compare the usual treatment alone (ibrutinib plus obinutuzumab) to using venetoclax plus the usual treatment. The addition of venetoclax to the usual treatment could prevent chronic lymphocytic leukemia from returning. But, it could also cause side effects.
There is evidence that both the study regimens are effective in the treatment of chronic lymphocytic leukemia. All of these therapies are already approved by the FDA for use in chronic lymphocytic leukemia.
This study will help the study doctors find out if one of the regimens is better than the other. To do this, the study doctors will look at how long remissions last in patients treated with the usual approach versus those treated with the three-drug combination. In the group of patients receiving the three-drug combination (ibrutinib, obinutuzumab, venetoclax), those patients who have no detectable CLL will stop ibrutinib after about a year, and those who still have evidence of CLL will continue ibrutinib.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 70 years of age or older.
- Have intermediate or high risk CLL.
- Have not received prior treatment 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.
- Have an active disease or malignancy that is expected to limit your survival to less than 5 years.
- Take more than 20 milligrams of prednisone or equivalent corticosteroid daily.
- Have a known allergy to mannitol.
- Have had prior significant hypersensitivity to rituximab.
This is a partial list of inclusion and exclusion criteria.