If you have chronic lymphocytic leukemia (CLL), you may wonder whether a clinical trial is right for you.
Clinical trials are research studies that involve people. They test new ways to prevent, find, and treat diseases like cancer. These studies also help doctors find ways to ease the side effects of cancer and its treatments.
Through a clinical trial, you may be able to try a new therapy that isn’t yet available to everyone. And when you take part, it could help others with CLL in the future.
“Clinicals trials are the path to finding additional treatments for patients at all stages of CLL, and hopefully, one day, a cure. Not long ago, today’s standard of care treatments were only available in clinical trials,” says Nina Logan, MD, director of research and clinical programs at the Leukemia and Lymphoma Society.
First, you need to know exactly what’s involved in a clinical trial: what studies are available, what the risks and benefits are, and what you’ll need to do if you do decide to sign up.
Is a Clinical Trial Right for You?
Clinical trials are usually an option for most people with CLL.
“A common misconception about clinical trials is that they are a last resort for patients, a place to go only when all other available treatments have failed. That could not be further from the truth,” Logan says. “In fact, a clinical trial could be the right treatment option for someone with CLL, even if they are treatment naive [someone who has not gotten any treatments], are currently receiving treatment, and even into survivorship.”
But certain studies may have specific rules about who they can accept. Your eligibility might depend on your:
- Age
- Overall health
- Medical and treatment history
- Family history
- Cancer’s stage
- Cancer’s genetic makeup
Pros and Cons of a Clinical Trial for CLL
The goal of a clinical trial is generally to find out if a treatment is safe and effective. There may be both pros and cons involved.
Some possible benefits of a clinical trial are:
- You might have access to a new treatment that you wouldn’t otherwise.
- The treatment you get may be better than standard therapies.
- You could help doctors find medicines that can help other people in the future.
- You may have more tests and checkups, which means doctors can watch your cancer better.
Potential downsides include:
- The experimental treatment you get may not be as effective as standard therapies.
- You could have side effects from the treatment.
- Extra tests, paperwork, and appointments may take up a lot of your time.
- You might have to pay for some of the treatments or the cost of travel.
Who Pays for a Clinical Trial?
Often, the sponsor of the clinical trial and health insurance companies cover the cost for you. But you may be asked to pay for certain procedures or therapies that your insurance won’t. It’s important to find out for sure what your health plan will cover before you decide to participate in the study.
Logan adds that the Leukemia and Lymphoma Society offers IMPACT research grants to improve access to clinical trials for underrepresented populations, like Black, Indigenous, and people of color (BIPOC); Hispanic people; and people from rural areas.
Clinical Trial Words to Know
Before researchers test a new treatment in people, they first do lab experiments and studies in animals.
Treatments go through different phases of testing:
Phase I tests the treatment on a small group of healthy volunteers, usually around 15-30 people. Scientists test the safety, the side effects that happen most often, and how your body breaks down and gets rid of the drug.
Phase II: A phase II trial usually involves between 50-100 volunteers. The main goal is to study whether the treatment works against the cancer. The researchers also keep studying the safety and side effects.
Phase III trials are large, with several hundred people. Scientists study how the drug compares to standard therapies. They might use the treatment in combination with other medicines. If the results are positive, the FDA will consider the treatment for approval.
Phase IV: The study happens after the FDA approves a new treatment. It lets scientists track the treatment’s safety and success in many more people.
In a randomized trial, you’ll be assigned to one treatment group or another by chance. (You won’t be able to choose which treatment group you’re in.)
In cancer trials, one group usually gets the experimental treatment and another “control” group gets the standard treatment. Placebos, which are treatments that appear real but aren’t, are rarely used in cancer clinical trials.
If it’s a blind trial, you won’t know which treatment you’re getting. If it’s a double-blind trial, the researchers won’t know what treatment you’re getting, either.
The principal investigator of the study is the person who supervises all parts of the clinical trial.
All trials must meet ethical standards and pass a detailed review of their goals and the way they do things.
How Do You Find a Clinical Trial?
Clinical trials for cancer happen all around the U.S. and the world. They may take place at cancer centers, medical facilities, community hospitals, doctors’ offices, or veterans and military hospitals. A single clinical trial may be done in hundreds of places or only a few.
You can go to www.clinicaltrials.gov and search for all CLL studies that are looking for patients.
The Leukemia and Lymphoma Society also offers a free clinical trial support center that can help you find and enroll in clinical trials. A designated nurse navigator in this program can help you get past any barriers to enrollment.
How Can You Talk to Your Doctor About Clinical Trials?
Logan says simply asking is the most important step.
“Don’t assume clinical trials aren’t for you, and don’t assume your health care team will automatically bring them up,” she says. “Ask questions about all available treatment options for your disease, including clinical trials. Be clear about your goals, what you want to get out of your treatment, and your concerns.”
You may want to ask questions such as these:
- Is there a CLL clinical trial I can join?
- What will the trial study?
- How is the study treatment different from the standard option?
- What are the pros and cons for me?
- Are there risks or side effects?
- How often will I get treatment, for how long, and where?
- How will we know if the treatment works?
- Who will be in charge of my care during the trial?
- How do I sign up?
CLL Drugs Tested in Clinical Trials
Clinical trials have paved the way for many effective therapies, including targeted medicines, Logan says. These drugs, which have now become standard treatment for many people with CLL, target specific proteins on cancer cells that help them grow.
In March 2024, the FDA approved CAR T-cell therapy to treat CLL. It uses a patient’s own immune system to attack cancer cells.
And there are many more treatments on the horizon.
“New therapies and drug combinations are evolving quickly, so when CLL patients do relapse, chances are, there will be a new treatment option waiting for them,” Logan says.
Show Sources
Photo Credit: Cultura RF/Andrew Brookes/Medical Images
SOURCES:
National Cancer Institute: “What are Clinical Trials?” “How Do Clinical Trials Work?” “Who Pays for Clinical Trials?”
Nina Logan, MD, director, Research Clinical Programs, Leukemia and Lymphoma Society.
National Institutes of Health: “What are Clinical Trials and Studies?”
Cancer Research UK: “The pros and cons of taking part in a clinical trial.”
American Cancer Society: “Targeted Therapy Drugs for Chronic Lymphocytic Leukemia.”
Leukemia and Lymphoma Society: “FDA Approves First CAR T-Cell Therapy for Chronic Lymphocytic Leukemia.”
