[logo] HealthTree Foundation
search more_vert
close
person Sign In / Create Account
arrow_back

Go back to trials list

A Phase 1 Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-453 in Adult Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)


Description

Chronic lymphocytic leukemia (CLL) is the most common leukemia in Western countries. The purpose of this study is to assess how well ABBV-453 works adult participants with relapsed/refractory (R/R) untreated CLL/small lymphocytic lymphoma (SLL). Adverse events, pharmacokinetics, and change in disease activity will be assessed. ABBV-453 is an investigational drug for the treatment of CLL and SLL. There are 2 parts to this study. In part A participants will be placed 1 of 5 cohorts with a specific target dose for each cohort and receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the appropriate target dose is achieved. In part B participants will be placed in 2 cohorts and receive up to the maximum dose in part A, with cohort 2.1 including a debulking period (obinutuzumab) as in part A. Approximately 80 adult participants with previously R/R CLL/SLL will be enrolled in the study in approximately 28 sites across the world. Participants in part

Trial Eligibility

Inclusion Criteria: * Relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) that has received at least 2 prior anti-cancer systemic therapies and does not have another therapy that is more appropriate at the judgement of the Investigator. * Laboratory values meeting those listed in the protocol. Exclusion Criteria: * QT interval corrected for heart rate (QTc) using Fridericia's correction of \> 470 msec (females) or \> 450 msec (males), Grade 3 arrythmia, and/or other clinically significant cardiac abnormalities. * Known to be B-cell leukemia/lymphoma 2 inhibitor (BCL-2i) refractory or has received a BCL-2i-containing regimen within (6 months) of starting study drug (e.g., venetoclax, lisaftoclax, BGV-11417). * Has active human immunodeficiency virus (HIV) infection. HIV testing is not required unless required locally. * Recent history (within 6 months) of: * Congestive heart failure (defined as New York Heart Association, Class 2 or higher). * Ischemic cardiovascular event. * Cardiac arrhythmia requiring pharmacological or surgical intervention. * Pericardial effusion. * Pericarditis. * Consumes known moderate or strong inhibitors of cytochrome P450 3A isoform subfamily (CYP3A) within 14 day or 5 half-lives of the drug (whichever is shorter) before the first dose of ABBV-453.

Study Info

Organization

AbbVie


Primary Outcome

Part A and B: Percentage of Participants With Adverse Events (AEs)


Outcome Timeframe Up to 5 Years

NCTID NCT06291220

Phases PHASE1

Primary Purpose TREATMENT

Start Date 2024-08-09

Completion Date 2029-07-21

Enrollment Target 80

Interventions

DRUG Obinutuzumab

DRUG ABBV-453

Locations Recruiting

City of Hope /ID# 253904

United States, California, Duarte


City of Hope Orange County Lennar Foundation Cancer Center /ID# 267158

United States, California, Irvine


Royal Prince Alfred Hospital /ID# 263129

Australia, New South Wales, Sydney


Austin Health /ID# 256776

Australia, Victoria, Heidelberg


Universitaetsklinikum Hamburg-Eppendorf /ID# 263730

Germany, Hamburg


Interested in joining this trial?

Our dedicated patient navigators are here to guide you through the validation and enrollment process with ease.

newsletter icon

Get the latest thought leadership on your Lymphoma delivered straight to your inbox

Subscribe to the weekly newsletter for news, stories, clinical trial updates, and helpful resources and events with cancer experts.