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RecruitingPHASE1INTERVENTIONAL

A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-319 Moves Through the Bodies of Adult Participants With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), or Chronic Lymphocytic Leukemia (CLL)

This study is looking into a new medicine called ABBV-319 for adults who have specific types of blood cancer: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), or chronic lymphocytic leukemia (CLL). These are cancers of white blood cells that have either returned after treatment or haven't responded well to standard therapies. The main goals are to check if ABBV-319 is safe, understand how it works in the body, and see if it can help reduce the cancer. The study will involve around 154 people globally and will test different doses of the medicine, which is given directly into a vein.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
AbbVie
Enrolment target
154
Start
26 Apr 2023
Estimated completion
01 Feb 2027

What is this study about?

This study is about a new treatment called ABBV-319 for certain types of blood cancer: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL). These are all cancers that affect a specific type of white blood cell called B-cells. For some people, these cancers can be difficult to treat because they might come back after treatment or not respond to current medicines. This new drug, ABBV-319, is still in the early stages of testing.

The main reasons for doing this study are to find out if ABBV-319 is safe for people to take and to understand how their bodies handle the medicine. Researchers will also be looking to see if the drug shows any promise in helping to control or shrink the cancer. This is a "Phase 1" study, meaning it's one of the first times this drug is being tested in humans, so the focus is primarily on safety and finding the right dose.

The study will involve about 154 adults from different places worldwide who have one of these types of cancer that has either returned or isn't responding to current treatments. The medicine, ABBV-319, will be given directly into a vein (intravenously) in a cycle that lasts 21 days.

Key takeaways

  • This study is testing a new drug called ABBV-319 for specific blood cancers.
  • It's for people whose lymphoma or leukemia has returned or isn't responding to current treatments.
  • The main goals are to check the drug's safety and see if it helps fight the cancer.
  • Participants will receive the medicine through a drip into a vein.
  • There will be more hospital visits and tests than usual care.
  • It's a 'Phase 1' study, meaning safety and dosage are key focuses.

Who may be eligible?

To join this study, you would need to be an adult with a confirmed diagnosis of diffuse large B-cell lymphoma, follicular lymphoma, or chronic lymphocytic leukemia. Importantly, your cancer must have either come back after previous treatment or not responded well to other medicines.

Also, your doctors need to be able to see and measure your cancer, meaning it's visible enough to track its progress. You will also need to have healthy enough blood test results to take part in the study, and if you've had a specific type of therapy before, you might need an extra biopsy (a small tissue sample).

There are also some reasons why you might not be able to join. For example, if your cancer has spread to your brain or spinal cord, or if you have an active infection. Your overall health and how well you can go about your daily activities will also be considered.

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.

  1. Are you an adult (18 years or older)?
  2. Do you have diffuse large B-cell lymphoma, follicular lymphoma, or chronic lymphocytic leukemia?
  3. Has your cancer come back after treatment or not responded to other medicines?
  4. Can your doctors see and measure your cancer?
  5. Are your routine blood tests within healthy limits?
  6. Is your overall health generally good enough to participate in a study?
Answer every question to see your result.

What does participation involve?

If you choose to join this study, you will receive the study drug ABBV-319, which is given directly into a vein. This will happen in repeating 21-day cycles. Initially, doctors will test different doses to find the best amount, and then other participants will receive that specific dose. You will need to attend regular appointments at a hospital or clinic approved for the study. These visits will involve various checks to see how you are doing, including medical examinations, blood tests, and answering questions about your health and how you feel. Doctors will also closely watch for any side effects. There might be more visits and tests than you would usually have for your standard cancer care.

Potential risks and benefits

Participating in a clinical trial like this could potentially offer a new treatment option if your current treatments haven't worked or your cancer has returned. However, because ABBV-319 is a new investigational drug, not all its side effects or benefits are fully known. There's a chance you might experience side effects, some of which could be serious. There's also no guarantee that the treatment will help your cancer. It's important to remember that joining is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (20)

  • University of Arizona Cancer Center - Tucson /ID# 247752
    Verified postcode
    Tucson, United States· Recruiting
  • Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232
    Verified postcode
    Miami, United States· Completed
  • Allina Health System /ID# 251782
    Verified postcode
    Minneapolis, United States· Recruiting
  • University of Nebraska Medical Center /ID# 246715
    Verified postcode
    Omaha, United States· Recruiting
  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246
    Verified postcode
    New York, United States· Recruiting
  • Novant Health Presbyterian Medical Center /ID# 246719
    Verified postcode
    Charlotte, United States· Recruiting
  • Baylor Sammons Cancer Center /ID# 247715
    Verified postcode
    Dallas, United States· Recruiting
  • University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234
    Verified postcode
    San Antonio, United States· Recruiting
  • Concord Repatriation General Hospital /ID# 249240
    Verified postcode
    Concord, Australia· Recruiting
  • St Vincent's Hospital Melbourne /ID# 247624
    City only
    Fitzroy Melbourne, Australia· Recruiting
  • One Clinical Research Pty Ltd /ID# 248392
    Verified postcode
    Nedlands, Australia· Recruiting
  • Cross Cancer Institute /ID# 246717
    Verified postcode
    Edmonton, Canada· Completed

Common questions

What kind of cancer does this study focus on?

This study is for adults with diffuse large B-cell lymphoma, follicular lymphoma, or chronic lymphocytic leukemia that has come back or isn't responding to other treatments.

What is ABBV-319?

ABBV-319 is a new medicine that researchers are testing to see if it can help treat these types of blood cancer.

How will I receive the medicine?

The medicine, ABBV-319, will be given directly into your vein (intravenously) in cycles that last 21 days.

What is a 'Phase 1' study?

Phase 1 means it's an early study focusing mainly on checking the safety of the new drug and finding the right dose for patients.

How long will I be in the study?

The study involves repeating 21-day cycles of treatment, and your participation will continue as long as the treatment is helping and you are tolerating it well, or until the study concludes.

How to find out more

ABBVIE CALL CENTER

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Assess the Adverse Events, Change in Disease Acti…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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