This trial is examining the effectiveness of ibrutinib (Imbruvica) and obinutuzumab (Gazyva) with or without venetoclax (Venclexta) in the treatment of chronic lymphocytic leukemia (CLL).
The main outcome to be measured will be survival without cancer growing or spreading. This trial is recruiting in various places around the United States.
The details
CLL is often treated with powerful drugs that target certain proteins. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer. It may interfere with the ability of tumor cells to grow and spread.
Drugs used in chemotherapy, such as venetoclax, work in different ways to stop the growth of cancer cells. They work either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib, obinutuzumab and venetoclax may work better in treating patients with CLL.
This trial is examining the effectiveness of ibrutinib and obinutuzumab with or without venetoclax in the treatment of CLL. The main outcome to be measured will be survival without the disease worsening. This will be assessed for up to 10 years.
Who are they looking for?
720 patients are needed for this trial. Patients should have adequate kidney and liver function tests. They should not have hemolytic anemia or autoimmune complications developed since CLL diagnosis. Patients with inflammatory bowel disease, serious digestive tract issues, known bleeding disorders, active hepatitis B/C, or patients with HIV and a detectable viral load will be excluded. Patients should not have another active cancer or a serious heart condition. Patients who have a recent infection (less than 14 days before the start of trial) requiring antibiotic treatment do not qualify.
Patients taking corticosteroids, immunosuppressant therapy, or other investigational agents do not qualify to participate. Patients must not take blood thinners or have had major surgery or radiation therapy within 4 weeks of the study. Women of childbearing age and sexually active males must use effective contraception or abstain from sexual intercourse for the duration, and for some time after the study.
How will it work
There will be two groups in this study. Patients will be randomly assigned to a group. A treatment course will last 28 days in this trial. One group will receive ibrutinib orally daily. They will also receive obinutuzumab through a drip placed in the vein (IV) over 4 hours on days 1, 2, 8, and 15 during the first course, and on day 1 of courses 2-6. These patients will also receive venetoclax tablets during course 3-14 of the trial. Treatment repeats for up to 19 courses. The second group of patients will receive ibrutinib orally and obinutuzumab IV the same as the first group.
Patients will be followed every 3 months for the first 2 years, every 6 months for years 3-5, and then every 12 months for years 6-10.
