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No longer recruiting (closed or complete)Last updated: 23 May 2025

M24-291: The purpose of this study is to assess how well a medicine called ABBV-453 works in people with relapsed or refractory, untreated, chronic lymphocytic leukaemia or small lymphocytic lymphomaA 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)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

M24-291

Clinical summary

Summary

This study has two parts. 

In Part A, participants will be placed into one 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 placed 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 debulking period, followed by escalating doses of ABBV-453 until the maximum target dose from Part A is achieved.

The estimated study duration is 5 years.

 

Conditions

This trial is treating people with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma

Eligibility

Inclusion

  • Relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) that has received at least 2 prior anti-cancer systemic therapies and does not have another therapy that is more appropriate at the judgement of the Investigator.
  • Laboratory values meeting those listed in the protocol.

Exclusion

  • 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.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

AbbVie

Scientific 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)

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