M24-291: ABBV-453 in subjects with Relapsed/Refractory CLL/SLL (Lymphoma) - Clinical Trial

What is the 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).

What is the Condition Being Studied?

Chronic Lymphocytic Lymphoma (CLL) and Small Lymphocytic Lymphoma (SLL)

Who Can Participate in the Study?

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

For more information about who can join this study, please contact the study team at quinna.marshburn@duke.edu.

Age Group
Adults

What is Involved?

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

Part B

If you participate in the study while Part A is enrolling, you will get an assignment (50:50) to 1 of 2 groups:

  • 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

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)
Principal Investigator
Hematologic Oncologist
Protocol Number
IRB: PRO00115631
NCT: NCT06291220
Phase
Phase I
ClinicalTrials.gov
Enrollment Status
Open for Enrollment