This trial is comparing the effectiveness of a combined regimen of venetoclax (Venclexta) and obinutuzumab (Gazyva) or VEN-G to an existing drug regimen of fludarabine (Fludara), cyclophosphamide (Cytoxan), and rituximab (Rituxan) or FCR, or bendamustine (Treanda) and rituximab or BR in patients with untreated chronic lymphocytic leukemia (CLL). The main outcome that is to be assessed is the minimal residual disease (MRD) response rate.
The details
CLL is a type of cancer of the white cells in the bone marrow. Chemoimmunotherapies such as FCR or BR are currently used in the treatment of CLL. Ventoclax (VEN) is a chemotherapy medication used in the treatment of CLL. Obinutuzumab (G) is a monoclonal antibody (immunotherapy). This study is going to examine the effectiveness of VEN+G in the treatment of CLL. The main outcome to be assessed is the MRD response rate (how many cancer cell remain after treatment).
Who are they looking for?
There are 165 patients to be recruited for this trial. To be recruited for this trial patients must have previously untreated CLL that requires treatment. Patients must have a good kidney and liver function. Patients must agree to remain abstinent from sexual intercourse or use effective birth control during the trial and must not donate sperm or eggs.
Patients will be excluded from this trial if they have CLL that has transformed to non-Hodgkins lymphoma or small lymphocytic lymphoma (SLL). Patients will also be excluded if they have CLL in the brain or other brain conditions. Patients who are pregnant, or actively breastfeeding are also excluded from this trial. Other exclusion criteria involve autoimmune disease, history of another cancer, infections (including HIV, hepatitis), or allergies to any of the drugs in the trial.
How will it work
There is to be two groups involved in this trial. Grou 1 will receive VEN+G fo 12 cycles of 28 days each. VEN will be administered orally, daily. G will be administered intravenously (IV) on Days 1 (and 2), 8, and 15 of Cycle 1 and on Day 1 of Cycles 2-6. Group 2 will receive either FCR or BR treatment for 6 cycles
The main outcome will be MRD response at month 15. Other outcomes evaluated will be survival without cancer worsening, duration of response, side effects, and quality of life. The trial will last up to 46 months.
