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NCT06291220 | RECRUITING | Chronic Lymphocytic Leukemia

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)
Sponsor:

AbbVie

Brief 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. 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 40 sites across the world. Participants in part A will placed into 1 of 5 cohorts with a specific target dose for each cohort and 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. Participants in part B will be place in one of 2 cohorts. Participants in cohort 2.1 will receive IV obinutuzumab as part of the debulking period, followed by escalating doses of oral ABBV-453 until the maximum target dose from part A is achieved. Participants in cohort 2.2 will receive no treatment during the the debulking period, followed by escalating doses of oral ABBV-453 until the maximum target dose from part A is achieved. The estimated study duration is 5 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.

Condition or disease

Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Intervention/treatment

Obinutuzumab

ABBV-453

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 80 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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)
Actual Study Start Date : 2025-01-27
Estimated Primary Completion Date : 2029-07
Estimated Study Completion Date : 2029-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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.
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.
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)

Location Details

NCT06291220

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

City of Hope /ID# 253904

Duarte, California, United States, 91010

RECRUITING

United States, California

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

Irvine, California, United States, 92618

RECRUITING

United States, Montana

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

Billings, Montana, United States, 59102

RECRUITING

United States, North Carolina

Atrium Health /ID# 265136

Charlotte, North Carolina, United States, 28204-2963

RECRUITING

United States, North Carolina

Duke Cancer Center /ID# 258707

Durham, North Carolina, United States, 27710-3000

RECRUITING

United States, Texas

MD Anderson Cancer Center /ID# 253713

Houston, Texas, United States, 77030

RECRUITING

Australia, New South Wales

Royal Prince Alfred Hospital /ID# 263129

Sydney, New South Wales, Australia, 2050

RECRUITING

Australia, Queensland

Gold coast University Hospital /ID# 255785

SouthPort, Queensland, Australia, 4215

RECRUITING

Australia, Victoria

Austin Health /ID# 256776

Heidelberg, Victoria, Australia, 3084

RECRUITING

Australia, Western Australia

Royal Perth Hospital /ID# 256464

Perth, Western Australia, Australia, 6000

RECRUITING

Germany, Baden-Wuerttemberg

Universitaetskliniku Ulm /ID# 263148

Ulm, Baden-Wuerttemberg, Germany, 89081

COMPLETED

Germany, Schleswig-Holstein

University Clinic Schleswig -Holstein - Campus Kiel /ID# 263150

As, Schleswig-Holstein, Germany, 24105

RECRUITING

Germany,

Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 263433

Berlin, Germany, 12203

RECRUITING

Germany,

Universitaetsklinikum Halle (Saale) /ID# 263299

Halle (Saale), Germany, 06120

RECRUITING

Germany,

Universitaetsklinikum Hamburg-Eppendorf /ID# 263730

Hamburg, Germany, 20246

RECRUITING

Israel, Hamerkaz

Yitzhak Shamir Medical Center /ID# 257626

Zerifin, Hamerkaz, Israel, 70300

RECRUITING

Israel, Tel-Aviv

The Chaim Sheba Medical Center /ID# 254383

Ramat Gain, Tel-Aviv, Israel, 5265601

RECRUITING

Israel, Yerushalayim

Hadassah Medical Center-Hebrew University /ID# 254721

Jerusalem, Yerushalayim, Israel, 91120

RECRUITING

Italy, Milano

IRCCS San Raffaele Hospital /Id# 263064

Milan, Milano, Italy, 20132

RECRUITING

Italy,

IRCCS Aou of Bologna Polyclinic Sant Orsola Malpighi /Id# 263065

Bologna, Italy, 40138

RECRUITING

Italy,

Hospital of Perugia - S. Maria della Misericordia /Id# 263062 Hospital

Perugia, Italy, 06156