This phase 2 clinical trial will test the effectiveness of ibrutinib (Imbruvica)with venetoclax (Venclexta) in treating patients with chronic lymphocytic leukemia (CLL). The primary outcome will be measured by the response to treatment. This trial is being conducted at the University of Texas MD Anderson Cancer Center in Houston, Texas.
The details
Ibrutinibis a drug that stops the growth of B-cells and may decrease the spread of CLL. It permanently binds to the Bruton's tyrosine kinase (BTK), a protein essential for B-cell growth and development. Since cancerous lymphocytes rely on mature B-cell signals to develop, blocking BTKs (thereby stopping B-cell maturation) could stop the spread of cancer. Venetoclax promotes cell death in cancer cells. It works by inhibiting (blocking the function of) Bcl-2, which is a protein that is often overexpressed in cancer cells. It is unclear whether the combination of drugs will improve the disease response.
The study will examine the response rate to the combination treatment over 2 months.
Who are they looking for?
This trial is recruiting 160 patients with relapsed or refractory CLL or untreated patients with high-risk CLL. Ideal candidates should not have major surgery or receive anticancer treatment within 3 weeks prior to enrollment.
Patients should not have any active infections, including hepatitis or HIV. Patients should not have an autoimmune disease requiring over 20 mg of prednisone a day. Those with a history of other serious primary cancers should be disease free for 2 years. Participants should not have received prior treatment with venetoclaxor ibrutinib.
How will it work
Patients will be divided into two groups based on disease state. One group will contain patients with relapsed or refractory (has not responded to treatment) CLL, and the other will consist of high-risk patients that have not had prior treatment. Both groups will receive the same treatment.
Participants will begin treatment with ibrutinibonly for three 28-cycles. Venetoclax treatment will then be added to ibrutinib beginning on cycle 4. The combination treatment will continue for 24 cycles (27 total cycles). Both drugs are taken daily by mouth. Patients will also receive a treatment to prevent tumor lysis syndrome. This condition can happen when tumor cells break down quickly, and the by-products enter the blood stream.
Treatment with venetoclax may continue for up to two years. Patients will also undergo physical exams, bone marrow biopsies (removal of bone marrow to test for presence of cancer cells) and PET scans.
