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)

Running, not enrolling · Phase 1

Conditions studied: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

In brief

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.

Key facts

Study ID

NCT06291220

Run by

AbbVie

People needed

4

Starts

2025-01-27

Expected to finish

2027-07-01

Last updated by the study team

2026-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) that has received at least 2 prior systemic therapies and have no available (or established) therapies known to provide clinical benefit and to which the participant would consent to receiving.
• Laboratory values meeting those listed in the protocol.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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