Active not recruitingPHASE1INTERVENTIONAL

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

This study is for adults diagnosed with specific types of B-cell cancers, such as Diffuse Large B-Cell Lymphoma, Chronic Lymphocytic Leukaemia, and other Non-Hodgkin's Lymphomas. These cancers affect B-cells, which are white blood cells important for fighting infections. The main goal is to test a new medicine called ABBV-525, taken as a tablet. Researchers want to see if it's safe, how well people tolerate it, how the body processes it, and if it shows any promise in treating these cancers by itself. About 150 adults worldwide will take part, receiving different doses of the medicine over several years. This is an early-stage study, meaning it's one of the first times this medicine is being tested in humans.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

AbbVie

Enrolment target

Start

04 Apr 2023

Estimated completion

01 Jul 2029

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

What is this study about?

This study is investigating a new oral medication called ABBV-525, which is being developed to treat certain types of B-cell cancers. B-cell cancers include conditions like lymphoma and leukaemia, and they affect a type of white blood cell in your body that normally helps fight off infections. When these cells become cancerous, they don't work properly.

The purpose of this research is to carefully evaluate ABBV-525. Firstly, researchers want to make sure it's safe for people to take and to understand any side effects. Secondly, they'll be looking at how the body handles the medicine – how it's absorbed, distributed, broken down, and removed. Finally, they'll be observing if the medicine shows any early signs of being effective in treating these B-cell cancers when used alone.

This is an important step in developing new treatments for these conditions. Because ABBV-525 is a new medicine, this study is designed to gather essential information about it before it can be used more widely. The study will involve around 150 adult participants from various locations globally.

Key takeaways

This study is testing a new tablet medicine, ABBV-525, for specific B-cell cancers.
It aims to check the medicine's safety, how the body handles it, and if it shows early signs of working.
Participants will attend regular hospital visits for tests and take the study medicine.
The study could last for over five years.
It's an early-stage study, so the full effects of the medicine are not yet known.

Who may be eligible?

To be considered for this study, you would generally need to have a specific diagnosis of certain B-cell cancers that have either returned or not responded to at least two previous treatments. For some parts of the study, if you have chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL), your cancer needs to be active enough to require treatment.

You should generally be in reasonably good health overall, meaning you can carry out most daily activities without too much difficulty, and doctors expect you to live for at least 12 more weeks. You would also need to have healthy blood counts and liver function. If you've had COVID-19 and recovered, or if you've had a brain or spinal cord disease that's now under control, you might still be able to join.

However, some conditions would prevent you from taking part. This includes if your cancer has spread to your brain or spinal cord, if you have certain bleeding problems, or if you've had a stroke or bleed in the brain in the last year. Also, if you have an active infection that isn't under control, certain types of hepatitis, or HIV, you wouldn't be able to join. You also can't have an active COVID-19 infection or any symptoms of it during the screening process.

Quick self-check

Do I have a specific B-cell cancer like listed (Diffused Large B-Cell Lymphoma, Chronic Lymphocytic Leukaemia, or Non-Hodgkin's Lymphoma)?
Has my cancer not responded to or returned after at least two previous treatments (or is active CLL/SLL)?
Am I generally well enough to go about most of my daily activities?
Do I have healthy blood counts and liver function?
Do I have tumour tissue available or can a new sample be taken?
Do I have any active infections, bleeding problems, or recent history of stroke or brain bleed?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, the total time involved could be up to 64 months (over 5 years). You would be asked to attend regular appointments at a hospital or clinic. These appointments will involve frequent check-ups by the study doctors, blood tests to monitor your health and how your body is reacting to the medicine, and various scans to see how the cancer is responding.

The study medicine, ABBV-525, is taken as a tablet by mouth. Participants will be divided into groups, and you might receive different doses of the medicine over time. In the early stages, doses might be gradually increased. Later, you might receive a specific dose that the researchers determine is best, and you'll continue on that dose for the remainder of your time in the study. Because this is a research study, you might have more appointments and tests than someone receiving standard care for your condition.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. You might not directly benefit from this study, but your contribution could help researchers learn more about new ways to treat B-cell cancers in the future. The main risks involve possible side effects from the new medicine, ABBV-525, which will be carefully monitored by the study team. There might also be discomfort from extra tests, like blood draws and scans, and the time commitment for hospital visits. It's important to remember that participating is completely voluntary, and you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (39)

University of California Los Angeles Medical Center /ID# 246357
Los Angeles, United States
Yale University School of Medicine /ID# 259081
New Haven, United States
Mount Sinai Medical Center-Miami Beach /ID# 248251
Miami Beach, United States
Fort Wayne Medical Oncology and Hematology, Inc /ID# 250113
Fort Wayne, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center /ID# 259872
Indianapolis, United States
Tulane Cancer Center Clinic /ID# 249586
New Orleans, United States
START Midwest /ID# 252359
Grand Rapids, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 245459
New York, United States
Atrium Health Levine Cancer Institute /ID# 246363
Charlotte, United States
University Of Cincinnati Medical Center /ID# 262288
Cincinnati, United States
University of Texas MD Anderson Cancer Center /ID# 245463
Houston, United States
University of Utah Health Hospital /ID# 259924
Salt Lake City, United States

+27 more sites — see the official record for the full list.

Common questions

What kind of cancers is this study looking at?

This study is for adults with specific B-cell cancers, including Diffuse Large B-Cell Lymphoma, Chronic Lymphocytic Leukaemia, and other types of Non-Hodgkin's Lymphoma.

What is ABBV-525?

ABBV-525 is a new medicine in tablet form that doctors are testing to see if it can treat B-cell cancers. It's still in the early stages of development.

How long will the study last if I join?

If you participate, the study could last for up to 64 months, which is over five years.

Will I have to go to the hospital often?

Yes, taking part means you will have regular visits to the hospital or clinic for check-ups, blood tests, and scans to monitor your health and the treatment's effects.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, and it will not affect the medical care you receive afterwards.