This trial is examining the effectiveness of ibrutinib and obinutuzumab with or without venetoclax in the treatment of older patients with chronic lymphocytic leukemia (CLL).
The main outcome to be measured will be survival without cancer worsening. This trial is recruiting in the United States.
Patients with CLL are often treated with medications that target different proteins on cancer cells. Ibrutinib (Imbruvica) may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with obinutuzumab (Gazyva) may induce changes in the immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as venetoclax (Venclexta) 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 and obinutuzumab with venetoclax may work better at treating CLL.
This trial is examining the effectiveness of ibrutinib and obinutuzumab with or without venetoclax in the treatment of older patients with CLL. The main outcome to be measured will be survival without cancer worsening. This will be assessed for up to 10 years.
Who are they looking for?
This study requires 454 patients with CLL. Patients must not have had prior therapy for CLL except with rituximab and/or corticosteroids for autoimmune complications of CLL. These treatments must be completed at least one month before the start of the trial. Patients must have adequate blood cell counts and liver and kidney function tests.
Patients should not have heart failure (stage III or IV), unstable angina, or abnormal heart rhythm. Patients with a history of heart attack, stroke, or bleed on the brain (haemorrhage) within 6 months will not qualify for the trial. Patients must not have an active infection requiring antibiotics through the vein. Patients with serious digestive tract issues, hepatitis B/C, or HIV with a detectable viral load will be excluded. Patients who have taken blood thinners within 10 days of the trail will be excluded.
How will it work
There will be two groups in this study. Patients will be randomly assigned to a group. One group will receive ibrutinib and obinutuzumab. The second group of patients will receive ibrutinib,obinutuzumab and venetoclax.
Patients who have a complete response to treatment will stop the medication and will be followed every 3 months for the first 6 years, and every 6 months after that. All patients will be followed for up to 10 years after the trial.