Purpose of this Study
This study has two groups. In the first group, people take a usual cancer medicine called zanubrutinib. It is taken as a pill by mouth two times each day, and the treatment is given in cycles that last 28 days.
In the second group, people take zanubrutinib first for a few cycles. After that, they also start taking a new study medicine called sonrotoclax. This medicine is added slowly, starting at a low dose and increasing step by step each week until the full dose is reached. This is done to help keep people safe and lower the risk of side effects.
The study compares these two treatment plans to see if adding the new medicine works better than the usual treatment alone.
Who Can Participate?
Eligibility
People can join this study if they have a blood cancer called chronic lymphocytic leukemia and meet medical rules that show they need treatment. They must not have been treated for this cancer before.
Participants must be 65 years old or older and healthy enough to take part in the study and do most daily activities. They cannot have had recent surgery or be taking certain blood thinning medicines like warfarin. They must also be able to swallow pills. Some treatments for complications must be finished before joining the study.
Age Range
65-100
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is trying to learn if adding a new medicine called sonrotoclax to a usual treatment called zanubrutinib can help people with this blood cancer. Researchers want to see if using both medicines together can keep the cancer from getting worse for a longer time compared to using the usual treatment alone.
The study will also look at a blood test that checks for very small amounts of cancer left in the body. Doctors want to learn if this test can help decide how long people should stay on treatment and help control the cancer better.
The goal of the study is to find out if this new approach works better than the usual care and can help people stay healthier for a longer time without their cancer getting worse.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
Protocol A042302, Phase III Evaluation of Fixed Duration Zanubrutinib plus Sonrotoclax-Based Therapy Compared to Continuous Zanubrutinib in Previously Untreated Older Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Principal Investigator
Danielle
Brander
Protocol Number
PRO00120149
NCT ID
NCT07321652
Phase
III
Enrollment Status
Open to Enrollment