You may be thinking about looking into clinical trials to help treat your chronic lymphocytic leukemia (CLL). These trials are research studies that help scientists study treatment safety and effectiveness. They could let you try cutting-edge treatments that aren’t yet widely available — and by taking part, you could help other people with your type of cancer.
“Clinical trials are an option worth exploring at any stage of the disease, not just in the late stages,” says Gwen Nichols, MD, chief medical officer of the Leukemia & Lymphoma Society.
First, you need to know exactly what’s involved: what trials are available, what they’re about, what the risks and benefits are, and what you’ll need to do if you do decide to sign up.
Is a CLL Clinical Trial Right for Me?
Clinical trials are an option for most people with CLL. Generally, you need to be in good health and not have other serious medical conditions if you want to enroll. Your doctor will also check your past treatments to make sure they’re in line with the rules of the study.
Many doctors will tell you about clinical trial options when you get a CLL diagnosis. Talking about trials is “part of my normal discussion with patients and families” when weighing treatment options, Nichols says.
Or you can start the conversation by asking 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?
You can also go to www.clinicaltrials.gov and search for all CLL studies that are recruiting patients. The Leukemia & Lymphoma Society also has a clinical trial support center that can help you find and enroll in clinical trials.
Keep in mind that experimental treatments might, or might not, work better than the standard treatment. That’s part of the goal of the trial: to see how well it works.
Also, find out what you (or your health insurance or Medicare plan) will be responsible for covering. Clinical trials usually pay for the cost of the treatment, but not unrelated medical costs. If you’d have to travel to take part in the trial, ask about those costs, too.
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. Scientists test the safety, the most frequent side effects, and how the body breaks down and gets rid of the drug.
Phase II includes people who have certain conditions. The main goal is to study the treatment’s effectiveness compared to people receiving a placebo during this phase. The researchers also continue to study the safety and side effects.
Phase III trials are large, with several hundred participants. Scientists study whether the drug works in different groups and at different dosages. 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 takes place 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 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.
All trials must meet ethical standards and pass a detailed review of their goals and methods.
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