A Study Assessing Adverse Event and How Oral ABBV-453 Moves Through the Body in Adult Participants With Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
NCT ID: NCT06291220
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
4 participants
INTERVENTIONAL
2025-01-27
2027-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A: Cohort 1.1 ABBV-453 Dose A
Participants will receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the dose A is achieved, during the 5 year study duration.
Obinutuzumab
Intravenous Infusion
ABBV-453
Oral; Tablet
Interventions
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Obinutuzumab
Intravenous Infusion
ABBV-453
Oral; Tablet
Eligibility Criteria
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Inclusion Criteria
* Laboratory values meeting those listed in the protocol.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
Universitaetsklinikum Ulm /ID# 263148
Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum Halle (Saale) /ID# 263299
Halle, Saxony-Anhalt, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel /ID# 263150
Kiel, Schleswig-Holstein, Germany
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 263433
Berlin, , Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 263730
Hamburg, , Germany
Yitzhak Shamir Medical Center /ID# 257626
Ẕerifin, Central District, Israel
Hadassah Medical Center-Hebrew University /ID# 254721
Jerusalem, Jerusalem, Israel
The Chaim Sheba Medical Center /ID# 254383
Ramat Gan, Tel Aviv, Israel
IRCCS Ospedale San Raffaele /ID# 263064
Milan, Milano, Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 263065
Bologna, , Italy
Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 263062
Perugia, , Italy
Countries
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Related Links
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Other Identifiers
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2023-507637-19
Identifier Type: OTHER
Identifier Source: secondary_id
M24-291
Identifier Type: -
Identifier Source: org_study_id
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