RECRUITING

Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

B-cell malignancies are a group of cancers of B lymphocytes, a type of white blood cell responsible for fighting infections. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-525 as a monotherapy. ABBV-525 is an investigational drug being developed for the treatment of B-Cell Malignancies. Study doctors put the participants in groups called treatment arms. Participants will receive ABBV-525 at different doses. Approximately 150 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), participants will receive escalating oral doses of ABBV-525. In part 2 (dose optimization), participants will receive one of two oral doses of ABBV-525, until the recommended phase 2 dose (RP2D) is determined. In part 3 (dose expansion), participants will receive the RP2D oral dose of ABBV-525. The estimated duration of the study is up to 64 months. 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 and may require frequent medical assessments, blood tests, and scans.

Official Title

A First-in-Human Study of ABBV-525 (MALT1 Inhibitor) in B-Cell Malignancies

Quick Facts

Study Start:2023-04-04
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05618028

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Dose Escalation (Part 1) Only: Participants with a documented diagnosis of one of the following third line or later of treatment (3L)+ mature B-cell malignancies, from the World Health Organization (WHO)-defined histologies as defined in the protocol.
  2. * Dose Optimization (Part 2) Only: Participants with documented diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with histology based on WHO criteria, with measurable disease requiring treatment as defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL).
  3. * Dose Expansion (Part 3) Only: Participants with documented diagnosis of one of the 3L+ mature B-cell malignancies based on WHO criteria listed in the protocol, with measurable disease requiring treatment.
  4. * Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2.
  5. * Participant has a life expectancy \>= 12 weeks.
  6. * Adequate hematological and hepatic function as defined in the protocol.
  7. * Must have archival or freshly collected tumor tissue for correlative studies before study enrollment.
  8. * Participants with prior central nervous system (CNS) disease that has been effectively treated may be eligible.
  9. * Participants with resolved coronavirus disease 2019 (COVID-19) infection are eligible.
  1. * Known active CNS disease, or primary CNS lymphoma.
  2. * Known bleeding disorders.
  3. * Known history of stroke or intracranial hemorrhage within 12 months prior to first dose of study treatment.
  4. * Uncontrolled active systemic infection, or active cytomegalovirus infection.
  5. * Active and/or chronic hepatitis B or C infection and/or the criteria listed in the protocol.
  6. * Known history of human immunodeficiency virus (HIV).
  7. * Known active COVID-19 infection. Participant must not have signs/symptoms associated with COVID-19 infection or known exposure to a confirmed case of COVID-19 infection during screening. If participant has signs/symptoms suggestive of COVID-19 infection, the participant must have a negative molecular (e.g., polymerase chain reaction) test or 3 negative antigen test results at least 24 hours apart.

Contacts and Locations

Study Contact

ABBVIE CALL CENTER
CONTACT
844-663-3742
abbvieclinicaltrials@abbvie.com

Principal Investigator

ABBVIE INC.
STUDY_DIRECTOR
AbbVie

Study Locations (Sites)

University of California Los Angeles /ID# 246357
Los Angeles, California, 90095
United States
Yale University School of Medicine /ID# 259081
New Haven, Connecticut, 06510
United States
Mount Sinai Medical Center-Miami Beach /ID# 248251
Miami Beach, Florida, 33140-2948
United States
Fort Wayne Medical Oncology and Hematology, Inc /ID# 250113
Fort Wayne, Indiana, 46804
United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center /ID# 259872
Indianapolis, Indiana, 46202-5116
United States
Tulane Cancer Center Clinic /ID# 249586
New Orleans, Louisiana, 70112
United States
START Midwest /ID# 252359
Grand Rapids, Michigan, 49546
United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 245459
New York, New York, 10065-6007
United States
Levine Cancer Institute /ID# 246363
Charlotte, North Carolina, 28204
United States
University Of Cincinnati Medical Center /ID# 262288
Cincinnati, Ohio, 45219
United States
University of Texas MD Anderson Cancer Center /ID# 245463
Houston, Texas, 77030
United States
University of Utah Health Hospital /ID# 259924
Salt Lake City, Utah, 84132
United States
Northwest Medical Specialties - Tacoma /ID# 260376
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: AbbVie

  • ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-04
Study Completion Date2027-06

Study Record Updates

Study Start Date2023-04-04
Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

  • Diffuse Large B-Cell Lymphoma
  • B-cell Malignancies
  • Chronic Lymphocytic Leukemia
  • Non-Hodgkin's Lymphoma
  • ABBV-525
  • Cancer

Additional Relevant MeSH Terms

  • Diffuse Large B-Cell Lymphoma
  • Chronic Lymphocytic Leukemia
  • B Cell Malignancies
  • Non-Hodgkin's Lymphoma