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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)
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. Participants will be enrolled with a specific target dose and receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the appropriate target dose is achieved. Approximately 60 adult participants with previously R/R CLL/SLL will be enrolled in the study in approximately 40 sites across the world. Participants will receive intravenous (IV) obinutuzumab as part of the debulking period, followed by escalating doses of oral ABBV-453 until the appropriate target dose is achieved. The estimated study duration is 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
City of Hope /ID# 253904
Duarte, California, United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 267158
Irvine, California, United States
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 264622
Billings, Montana, United States
Atrium Health /ID# 265136
Charlotte, North Carolina, United States
Duplicate_Duke Cancer Center /ID# 258707
Durham, North Carolina, United States
MD Anderson Cancer Center /ID# 253713
Houston, Texas, United States
Royal Prince Alfred Hospital /ID# 263129
Sydney, New South Wales, Australia
Gold coast University Hospital /ID# 255785
Southport, Queensland, Australia
Austin Health /ID# 256776
Heidelberg, Victoria, Australia
Royal Perth Hospital /ID# 256464
Perth, Western Australia, Australia
Start Date
January 27, 2025
Primary Completion Date
July 1, 2027
Completion Date
July 1, 2027
Last Updated
January 8, 2026
4
ACTUAL participants
Obinutuzumab
DRUG
ABBV-453
DRUG
Lead Sponsor
AbbVie
NCT07277231
NCT05006716
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06859424