This study is searching for patients with previously untreated chronic lymphocytic leukemia (CLL) to try a new treatment combination containing obinutuzumab (Gazyva) or obinutuzumab/bendamustine (Treanda) to shrink the tumor (debulking) before treatment with venetoclax (Venclexta). The main outcome that will be measured is the number of patients who achieve a low tumor burden following treatment. This trial is recruiting across the United States.
The details
Tumor debulking involves shrinking the tumor. This often increases the effectiveness of other anti-cancer drugs. Obinutuzumab is often used alone, or in combination with bendamustine after debulking for CLL. Venetoclax is a new drug which is approved to treat CLL.
This study will investigate the effectiveness of obinutuzumab combined with venetoclax after CLL debulking. The main outcome that will be measured is the percentage of patients that achieve a low tumor burden after 24 weeks.
Who are they looking for?
This study will include 100 patients. Participants must have adequate blood, kidney and liver function. To be included, participants must not have received treatment for CLL. Participants must have a medium or high tumor burden.
Patients with CLL that has developed into severe Hodgkin’s or non-Hodgkin’s lymphoma will not be included. Patients with a type of blood cancer called prolymphocytic leukemia cannot participate.
How will it work
All participants will initially receive the same treatment. Participants will undergo debulking with up to 6 cycles of obinutuzumab with or without bendamustine. If a low tumor burden is achieved during debulking, participants will be treated with venetoclax and obinutuzumab. If a low tumor burden has not been achieved after 6 rounds of debulking, the physician may adjust the treatment regime to include venetoclax.
Participants will be treated with a combination of obinutuzumab and venetoclax for 5 months. After this, participants will be treated with venetoclax alone for 52 weeks. Patients will be followed up for up to 3.5 years.
