Purpose of this Study
We are doing this study to find out if an experimental drug called ABBV-453 (the study drug) is a safe and effective option for patients with chronic lymphocytic lymphoma (CLL) or small lymphocytic lymphoma (SLL).
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with CLL or SLL
- Did not have a good response to past treatment or had their disease come back after treatment
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The study is divided into two parts, Part A and Part B. Whether you participate in Part A or Part B will depend on when you join the study.
If you choose to join the study, you will go through a screening period that lasts about 3 weeks to see if you are eligible. If you are eligible to join, you will proceed to the dosing period.
Part A
If you participate in the study while Part A is enrolling, you will:
- Get a dose of obinutuzumab through an intravenous (IV) infusion on back-to-back days about 2 weeks before you start taking the study drug
- Take the study drug by mouth on a weekly basis for up to 2 years
- One group will get obinutuzumab and the study drug in a similar manner to the participants in Part A
- The other group get the study drug without taking obinutuzumab first
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase 1 Study of ABBV-453 in Adult Subjects with Relapsed or Refractory
Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Principal Investigator
Danielle
Brander
Protocol Number
PRO00115631
NCT ID
NCT06291220
Phase
I
Enrollment Status
Pending Open to Enrollment