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NCT05618028 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets
A Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT05618028 is a Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma that is actively recruiting participants, run by AbbVie. The registered enrollment target is 150 participants, below the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (17% lower). The trial reports 20 study locations across 17 states.
The verdict
NCT05618028, a Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG ABBV-525
Study Locations (20)
Indiana
- Fort Wayne Medical Oncology and Hematology, Inc /ID# 250113 - Fort Wayne
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center /ID# 259872 - Indianapolis
New South Wales
- Liverpool Hospital /ID# 260191 - Liverpool
- Orange Health Service /ID# 260473 - Orange
Victoria
- Monash Health - Monash Medical Centre /ID# 246366 - Clayton
- The Alfred Hospital /ID# 248592 - Melbourne
California
- University of California Los Angeles Medical Center /ID# 246357 - Los Angeles
Connecticut
- Yale University School of Medicine /ID# 259081 - New Haven
Florida
- Mount Sinai Medical Center-Miami Beach /ID# 248251 - Miami Beach
Louisiana
- Tulane Cancer Center Clinic /ID# 249586 - New Orleans
Michigan
- START Midwest /ID# 252359 - Grand Rapids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2023-04-04 |
| Est. Completion | 2029-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05618028
The ClinicalTrials.gov registry entry for NCT05618028 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (17% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which ABBV-525 is the first listed.
NCT05618028 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Indiana, New South Wales, Victoria.
Frequently Asked Questions
What is clinical trial NCT05618028 about?
NCT05618028 is a clinical study titled "Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets". 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...
What is the current status of trial NCT05618028?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 150 participants. The study started on 2023-04-04. Estimated completion is 2029-07.
What conditions does trial NCT05618028 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Diffuse Large B Cell Lymphoma, Non-Hodgkin's Lymphoma, B-cell Malignancies.
What interventions are being tested in trial NCT05618028?
The interventions under investigation include: ABBV-525 (DRUG).
Who is sponsoring clinical trial NCT05618028?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05618028 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Indiana, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.