Study ID: EA9161
A randomized phase III study of the addition of venetoclax to ibrutinib and obinutuzumab versus ibrutinib and obinutuzumab in untreated younger patients with chronic lymphocytic leukemia
Researchers are studying the safety and efficacy of adding the FDA-approved oral drug Venclexta® (venetoclax) to treatment regimens for patients aged 18 to 70 who have been diagnosed with chronic lymphocytic leukemia (CLL).
All study participants receive the oral drug Imbruvica® (ibrutinib) and Gazyva® (obinutuzumab), a medication given intravenously. Both drugs are FDA approved to treat CLL.
Participants are randomized into two study groups. One group receives ibrutinib and obinutuzumab. The other group receives those two medications and venetoclax.
This phase III clinical trial is testing the safety and efficacy of adding venetoclax to the treatment regimen of ibrutinib and obinutuzumab for CLL in patients aged 18 to 70.
Eligible patients must have at least one of the following:
- Progressive marrow failure
- Symptomatic/progressive lymphadenopathy, splenomegaly or hepatomegaly
- One or more of: weight loss of more than 10% within the previous six months; grade 2/3 fatigue attributed to CLL; fevers > 100.5°F for two weeks without evidence of infection; clinically significant night sweats without evidence of infection
- Progressive lymphocytosis (not due to corticosteroids) with an increase of > 50% over a two-month period or anticipated doubling time of < six months
- A deletion of 17p13 on cytogenetic analysis by FISH
- Active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment
Other inclusion/exclusion criteria apply.
- Arm A: ibrutinib, obinutuzumab and venetoclax
- Arm B: ibrutinib and obinutuzumab
Monthly visits are required during cycles one through seven. Three-month visits are required after cycle eight.
- Must have been diagnosed with CLL
- Must not have been treated previously with chemotherapy, BTK inhibitors, venetoclax, small molecule signaling inhibitors or monoclonal antibodies for treatment of CLL