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)

Last updated: January 7, 2026
Sponsor: AbbVie
Overall Status: Active - Not Recruiting

Phase

1

Condition

Lymphoma

Lymphocytic Leukemia, Chronic

Leukemia

Treatment

ABBV-453

Obinutuzumab

Clinical Study ID

NCT06291220
M24-291
2023-507637-19
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/ small lymphocyticlymphoma (SLL) that has received at least 2 prior systemic therapies and have noavailable (or established) therapies known to provide clinical benefit and to whichthe participant would consent to receiving.

  • Laboratory values meeting those listed in the protocol.

Exclusion

Exclusion Criteria:

  • QT interval corrected for heart rate (QTc) using Fridericia's correction of > 470msec (females) or > 450 msec (males), Grade 3 arrythmia, and/or other clinicallysignificant cardiac abnormalities.

  • Known to be B-cell leukemia/lymphoma 2 inhibitor (BCL-2i) refractory or has receiveda 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 requiredunless required locally.

  • Recent history (within 6 months) of:

  • Congestive heart failure (defined as New York Heart Association, Class 2 orhigher).

  • 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 thefirst dose of ABBV-453.

Study Design

Total Participants: 4
Treatment Group(s): 2
Primary Treatment: ABBV-453
Phase: 1
Study Start date:
January 27, 2025
Estimated Completion Date:
July 31, 2027

Connect with a study center

  • Royal Prince Alfred Hospital /ID# 263129

    Sydney, New South Wales 2050
    Australia

    Site Not Available

  • Royal Prince Alfred Hospital /ID# 263129

    Sydney 2147714, New South Wales 2155400 2050
    Australia

    Site Not Available

  • Gold coast University Hospital /ID# 255785

    SouthPort, Queensland 4215
    Australia

    Site Not Available

  • Gold coast University Hospital /ID# 255785

    Southport 2148928, Queensland 2152274 4215
    Australia

    Site Not Available

  • Austin Health /ID# 256776

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • Austin Health /ID# 256776

    Heidelberg 2163654, Victoria 2145234 3084
    Australia

    Site Not Available

  • Royal Perth Hospital /ID# 256464

    Perth, Western Australia 6000
    Australia

    Site Not Available

  • Royal Perth Hospital /ID# 256464

    Perth 2063523, Western Australia 2058645 6000
    Australia

    Site Not Available

  • Universitaetsklinikum Ulm /ID# 263148

    Ulm, Baden-Wuerttemberg 89081
    Germany

    Site Not Available

  • Universitaetsklinikum Ulm /ID# 263148

    Ulm 2820256, Baden-Wurttemberg 2953481 89081
    Germany

    Site Not Available

  • Universitaetsklinikum Halle (Saale) /ID# 263299

    Halle 2911522, Saxony-Anhalt 2842565 06120
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel /ID# 263150

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel /ID# 263150

    Kiel 2891122, Schleswig-Holstein 2838632 24105
    Germany

    Site Not Available

  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 263433

    Berlin, 12203
    Germany

    Site Not Available

  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 263433

    Berlin 2950159, 12203
    Germany

    Site Not Available

  • Universitaetsklinikum Halle (Saale) /ID# 263299

    Halle (Saale), 06120
    Germany

    Site Not Available

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 263730

    Hamburg, 20246
    Germany

    Site Not Available

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 263730

    Hamburg 2911298, 20246
    Germany

    Site Not Available

  • Yitzhak Shamir Medical Center /ID# 257626

    Ẕerifin 293084, Central District 294904 70300
    Israel

    Site Not Available

  • Yitzhak Shamir Medical Center /ID# 257626

    Zerifin, HaMerkaz 70300
    Israel

    Site Not Available

  • Hadassah Medical Center-Hebrew University /ID# 254721

    Jerusalem 281184, Jerusalem 293198 91120
    Israel

    Site Not Available

  • The Chaim Sheba Medical Center /ID# 254383

    Ramat Gan 293788, Tel Aviv 293396 5265601
    Israel

    Site Not Available

  • The Chaim Sheba Medical Center /ID# 254383

    Ramat Gan, Tel-Aviv 5265601
    Israel

    Site Not Available

  • Hadassah Medical Center-Hebrew University /ID# 254721

    Jerusalem, Yerushalayim 91120
    Israel

    Site Not Available

  • IRCCS Ospedale San Raffaele /ID# 263064

    Milan, Milano 20132
    Italy

    Site Not Available

  • IRCCS Ospedale San Raffaele /ID# 263064

    Milan 3173435, Milano 20132
    Italy

    Site Not Available

  • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 263065

    Bologna, 40138
    Italy

    Site Not Available

  • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 263065

    Bologna 3181928, 40138
    Italy

    Site Not Available

  • Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 263062

    Perugia, 06156
    Italy

    Site Not Available

  • Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 263062

    Perugia 3171180, 06156
    Italy

    Site Not Available

  • City of Hope /ID# 253904

    Duarte, California 91010
    United States

    Site Not Available

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

    Irvine, California 92618
    United States

    Site Not Available

  • City of Hope /ID# 253904

    Duarte 5344147, California 5332921 91010
    United States

    Site Not Available

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

    Irvine 5359777, California 5332921 92618
    United States

    Site Not Available

  • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 264622

    Billings, Montana 59102
    United States

    Site Not Available

  • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 264622

    Billings 5640350, Montana 5667009 59102
    United States

    Site Not Available

  • Atrium Health /ID# 265136

    Charlotte, North Carolina 28204-2963
    United States

    Site Not Available

  • Duke Cancer Center /ID# 258707

    Durham, North Carolina 27710-3000
    United States

    Site Not Available

  • Atrium Health /ID# 265136

    Charlotte 4460243, North Carolina 4482348 28204-2963
    United States

    Site Not Available

  • Duplicate_Duke Cancer Center /ID# 258707

    Durham 4464368, North Carolina 4482348 27710-3000
    United States

    Site Not Available

  • MD Anderson Cancer Center /ID# 253713

    Houston, Texas 77030
    United States

    Site Not Available

  • MD Anderson Cancer Center /ID# 253713

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

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