RecruitingPHASE1INTERVENTIONAL

Study to Evaluate Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-291 Moves Through the Body in Adult Participants With Non-Hodgkin's Lymphoma

This research study is investigating a new medication, ABBV-291, for adults who have a type of cancer called Non-Hodgkin's Lymphoma. This is specifically for those whose cancer has returned or hasn't improved with previous treatments. The main goals are to find out if ABBV-291 is safe to use and how well people tolerate it. Researchers will also look at how the medicine moves through the body and if it shows early signs of helping to reduce the cancer. The study involves giving ABBV-291 through a drip into a vein. Participants will have regular hospital visits for assessments and blood tests, and doctors will closely monitor for any side effects. This study includes different stages to determine the best dose and then to see its effects on the cancer.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

AbbVie

Enrolment target

165

Start

16 Jan 2025

Estimated completion

01 Nov 2031

Non-Hodgkin's Lymphoma

What is this study about?

This study is for adults with Non-Hodgkin's Lymphoma, a type of cancer affecting white blood cells. If your cancer has come back after treatment or hasn't responded to previous treatments, this study might be relevant to you. The main purpose is to explore a new treatment called ABBV-291. Researchers want to understand if this medicine is safe to use, how well people tolerate it, and how it moves through the body. They will also look for early signs that ABBV-291 might help reduce the cancer.

ABBV-291 is an experimental drug, meaning it's still being tested and isn't yet available for general use. The study is divided into different parts. In the first part, called "dose escalation," a small group of participants will receive increasing doses of ABBV-291 to find the highest dose that can be given safely. Once that dose is found, more people will join the second part of the study, where researchers will look more closely at how the medicine affects the cancer.

This study will involve around 165 adult participants from different places around the world. It’s important to remember that this is an early-stage study (Phase 1), which means the main focus is on safety and finding the right dose, rather than on proving how effective it is compared to existing treatments.

Key takeaways

This study is testing a new medicine (ABBV-291) for Non-Hodgkin's Lymphoma.
It's for adults whose cancer has returned or hasn't responded to other treatments.
The main goals are to check the medicine's safety and find the right dose.
ABBV-291 is given through a drip into a vein.
Participation involves regular hospital visits and close monitoring for side effects.
The study is an early stage (Phase 1) investigation of the medicine.

Who may be eligible?

This study is looking for adults aged 18 or older. To be considered, you must have a confirmed diagnosis of certain types of B-cell Non-Hodgkin's Lymphoma, and your doctor must confirm that your cancer requires treatment and can be measured.

The specific types of Non-Hodgkin's Lymphoma vary depending on which part of the study you might join. These include various forms of Diffuse Large B-cell Lymphoma (DLBCL), Mantle Cell Lymphoma (MCL), and Follicular Lymphoma (FL). Other types like Marginal Zone Lymphoma (MZL) and Waldenstrom Macroglobulinemia (WM) may also be considered for certain parts of the study.

Your medical team will check your detailed diagnosis against the study's requirements to see if you are a suitable match.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of certain types of B-cell Non-Hodgkin's Lymphoma?
Has your cancer come back or not responded to previous treatments?
Does your doctor confirm your cancer needs treatment and can be measured?
Are you generally well enough to participate in a clinical study?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will receive ABBV-291, which is given into a vein through a drip (intravenously). Initially, in the dose-finding part, the amount of medicine you receive will gradually increase until the researchers find the most suitable dose. The study is expected to last for a long time, potentially around 74 months (over six years), although your individual participation might vary.

You will need to attend regular visits at a hospital or clinic approved for the study. During these visits, the study team will carry out various checks to see how you are responding to the treatment and to monitor your health. These will include medical examinations, blood tests, and careful tracking of any side effects you might experience. These frequent checks are essential to understand the medicine's effects.

Potential risks and benefits

Participating in a clinical trial may offer the potential benefit of accessing an experimental treatment before it is widely available. However, there are also potential risks, as ABBV-291 is a new medicine whose side effects are not yet fully known. There is a chance you may experience side effects, and the study requires more frequent hospital visits and tests compared to standard care, which might be demanding. You have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (14)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Carolina BioOncology Institute /ID# 265259
Verified postcode
Huntersville, United States· Completed
Willamette Valley Cancer Institute and Research Center /ID# 270945
Verified postcode
Eugene, United States· Recruiting
Texas Oncology - Central/South Texas /ID# 270946
Verified postcode
Austin, United States· Recruiting
START Mountain Region /ID# 267592
Verified postcode
West Valley City, United States· Completed
Virginia Cancer Specialists - Fairfax /ID# 265082
Verified postcode
Fairfax, United States· Completed
St Vincent's Hospital Melbourne /ID# 261664
Unverified
Fitzroy Melbourne, Australia· Recruiting
Sir Charles Gairdner Hospital /ID# 268579
Verified postcode
Nedlands, Australia· Recruiting
Hadassah Medical Center-Hebrew University /ID# 261658
Verified postcode
Jerusalem, Israel· Recruiting
Tel Aviv Sourasky Medical Center /ID# 261659
Verified postcode
Tel Aviv, Israel· Recruiting
Aichi Cancer Center /ID# 267471
Verified postcode
Nagoya, Japan· Recruiting
National Cancer Center Hospital East /ID# 261775
Unverified
Kashiwa-shi, Japan· Recruiting
The Cancer Institute Hospital Of JFCR /ID# 267470
Unverified
Koto-ku, Japan· Recruiting

Common questions

What is Non-Hodgkin's Lymphoma?

It's a type of cancer that starts in white blood cells called lymphocytes, which are part of your body's immune system.

What does 'relapsed or refractory' mean?

This means your cancer has either come back after treatment (relapsed) or hasn't responded to previous treatments (refractory).

How will I receive the study medicine, ABBV-291?

The medicine will be given directly into your bloodstream through a drip, which is called an intravenous infusion.

Will I have more hospital visits than usual?

Yes, participation in the study typically involves more frequent visits to the hospital or clinic for assessments and monitoring compared to standard care.

Can I stop participating in the study if I want to?

Yes, you are free to leave the study at any time, for any reason, and this will not affect your usual medical care.

How to find out more

ABBVIE CALL CENTER

abbvieclinicaltrials@abbvie.com 844-663-3742 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.