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What are CLL Clinical Trials and Why Consider One?
Posted: Sep 26, 2023
What are CLL Clinical Trials and Why Consider One? image

Discover the world of clinical trials and how they unlock the potential to transform CLL healthcare. Curious about what clinical trials are and why you should consider participating in one? Explore the information below where you'll find explanations about the significance of clinical trials and their impact on CLL cure advancements. Gain insights into cutting-edge treatments, patient benefits, and how you can contribute to shaping the future of CLL healthcare. 

Find a clinical trial through our clinical trial finder here.

Read about the latest updates in several ongoing CLL clinical trials here.

What are CLL Clinical Trials?

Clinical trials are research studies that patients can volunteer to participate in. Clinical trials help research communities find better ways to prevent, diagnose and/or treat cancer. Currently, only 8% of cancer patients participate in clinical trials. This is believed to be because of a lack of understanding about clinical trials and the power they have to help better CLL care. 

Areas Clinical Trials May Cover

  • Comparing the current FDA-approved standard care medicines against newer potentially more effective medicines 
  • Treatments that have been approved by the FDA but they look at different ways of administering the treatments such as in combinations or different doses
  • Immunotherapies like CAR T-cell therapy 
  • Health-related quality of life patient surveys 
  • Reviewing the impact of treating CLL earlier rather than after the watch and wait period
  • Strategies to reduce disease and/or treatment-related side effects 
  • Ways to better strengthen the immune system before treatment

How clinical trials work

Every clinical trial follows a specific protocol. Protocols consists of:

  • An explanation of the treatment plan
  • A list of the medical tests you might receive
  • Information on how many patients will participate in the clinical trial
  • Requirements that help determine if you are qualified to join the trial
  • Safety information

There should also be a very thorough and informed consent process of learning about the clinical trial before you decide to take part in it. You should learn the purpose of the trial, how long it will take, what will happen, all potential risks and benefits, and information on the privacy of your medical records.

If you want to participate, you will sign a consent form that details all of the information that has been discussed. You will be able to take that form home and refer to it at any time. Even though you have signed the consent form, you still have the right to leave the study at any time and for any reason.

Informed consent continues throughout the trial. This will give the research team an opportunity to update you on the progress of the trial as well as any side effects or other risks that have been identified.

Phases of clinical trials

Clinical trials are only done when there is good reason to believe that a new test or treatment can improve the care of patients. Treatments are tested in preclinical research. Preclinical research is not done with people.

After preclinical research, treatments go through a series of clinical trials. Clinical trials have five phases. The phases are described next using the example of a new medicine:

PHASE 0

Phase 0 trials are the first clinical trials that involve people. This phase is to learn how a medicine is processed in the body, how it affects the body, and does it reach the cancer cells. A very small dose of a medicine is given to about 10 to 15 people.

PHASE I

This phase is generally tested in a small group of 15 to 30 patients and seeks to find out:

  • If the new treatment is safe (fewest side effects)
  • The best way to give the new treatment, such as by mouth or by vein, and at what dose
  • If there are signs that cancer responds to the new treatment

PHASE II

Phase II trials are to further analyze the safety of the medicine as well as if a medicine works. These trials are tested in groups of less than 100 patients.

PHASE III

Phase III trial's purpose is to compare the new medicine to the current medicine it could replace. This phase monitors the side effects of each medicine and which one works better. This phase is tested in hundreds to thousands of patients.

Patients who enroll in a Phase III clinical trial have a chance of being in one of the following randomly selected groups:

  • Control group – gets the current standard treatment
  • Study group – gets the new treatment being tested

You don’t get to choose what group you are in, this is assigned at random. You will also not know which group you’re in until the trial is over.

PHASE IV

Phase IV trials continue testing new medicines that have been recently approved by the FDA. The medicine is tested in hundreds to thousands of patients worldwide. This allows for a better understanding of short and long-term side effects, safety, and benefits of the new medicine.

Benefits & risks

Possible benefits may include: 

  • If the new treatment works, you may be one of the first people to benefit from the treatment
  • You may receive additional expert medical care
  • You will be closely monitored for side effects
  • You will take an active role in your own healthcare
  • You may be able to help future cancer patients and contribute to cancer research

Possible risks may include: 

  • A trial can sometimes require more time and medical attention such as doctor visits, phone calls, more treatments, a hospital stay, or a more complicated treatment regimen
  • Expected side effects
  • Side effects the doctor did not anticipate from the treatment 
  • New treatments are not always better than, or as good as, current treatments
  • The new treatment may not work for you even if it works for other patients

Cost of clinical trials

All clinical trials are different. Oftentimes, the treatment itself in the clinical trial is covered by the sponsors of the study. Surrounding care such as blood tests, however, may or may not be covered by the study's sponsors and the patient will need to review insurance coverage. Consult with the clinical trial's investigators to get answers to these questions.

Other financial coverage questions you should ask the clinical trial's team include: 

  • What costs will be covered by the clinical trial? For example, my insurance company may not cover blood tests that aren't part of my regular care
  • Will I be responsible for my copays and deductibles associated with my insurance plan for routine visits?
  • Where will the visits be? Find out the name of the location so that you can confirm with your insurance network
  • Are costs associated with travel to the study's site and/or meals reimbursed?
  • Has the study team heard from other patients about issues with insurance coverage? If the study team says that other patients have had issues with insurance coverage, or if you have spoken with your insurance company and think there will be problems, consider creating a packet of materials to submit to your insurance provider in support of the trial. The clinical trial coordinator or research nurse with the study may be able to help you put together a packet that demonstrates why the trial is right for you. The packet can include things such as:
    • Medical journal articles from prior studies that explain the potential benefit of the treatment
    • A letter from your doctor that explains the trial or why the trial is medically necessary
    • A letter from other outside supporters of the trial, such as a patient advocacy group

You need to understand the costs you'll be responsible for before participating in a trial. If you have questions, reach out to the clinical trial's investigator (listed on the study's page) or HealthTree's clinical trial study team who are here to help you navigate these questions. 

Eligibility for clinical trials

How do I know if I can join a clinical trial? 

Not all clinical trials are right for all patients. Each study has certain inclusion and exclusion criteria. These filtering criteria help preserve the health of patients to avoid treatments that could potentially harm them. Eligibility criteria include information about you and your overall health such as:

  • Age and gender
  • Results of medical tests
  • Medicines you take
  • Any health problems
  • Your cancer type and stage
  • Other treatments you may have had
  • How long it has been since you were last treated

Things to consider before joining a clinical trial 

Treatment:

  • The reason for the clinical trial (what the doctors hope to learn)
  • Who is eligible to take part in the clinical trial
  • What is known about the type of treatment being studied
  • Possible risks and benefits (based on what is known so far)
  • Other treatment options available to you

Tests:

  • Types of tests
  • How often you need tests
  • How often you meet with the doctor

Costs:

  • Who pays for the clinical trial
  • If the clinical trial causes you to need more medical care, who pays for those costs

My Research Team: 

  • You will have a research team that will care for you during the trial which includes:
    • Principal investigator (PI) who is usually a doctor. They run the clinical trial and make sure the healthcare team follows the plan
    • Research nurse who teaches you about the trial and collects data from you

Am I allowed to quit the clinical trial? 

You are a volunteer and can choose to stop a clinical trial at any time. You should speak with your doctor first to see if stopping could affect your health, the best way to stop taking the medications, or if there are other treatment options available to you. If a clinical trial isn’t proving to be successful for you, you can have the option of stopping and starting another clinical trial or a different course of treatment. 

When Should I Start Thinking About Joining a Clinical Trial? 

Dr. Meghan Thompson helped explain when it’s appropriate for CLL patients to start thinking about joining a clinical trial. Watch her video below to learn more: 

Dr. Thompson explained that there are usually clinical trials available for CLL patients in any stage of the cancer. For example, there are clinical trials for patients before treatment starts to help review the best supportive care like prevention of infection and how to best support the immune system. Other clinical trials help refine and improve the current standard of care for the patient’s first treatment. 

For CLL patients whose cancer has come back after a line of treatment or whose disease has stopped responding to treatments (relapsed/refractory), there are also clinical trials available. Some of these include trying new potentially better medicines than the current standard of care. 

Dr. Thompson recommends CLL patients talk with their doctor at each stage of their care journey to review if a clinical trial is right for them. 

Clinical trials have the potential to help better the treatment landscape for the CLL patient community. We invite you to consider joining a clinical trial you are eligible for to help us in this goal. See here to check out clinical trials you may qualify for! 

The author Megan Heaps

about the author
Megan Heaps

Megan joined HealthTree in 2022. As a writer and the daughter of a blood cancer patient, she is dedicated to helping patients and their caregivers understand the various aspects of their disease. This understanding enables them to better advocate for themselves and improve their treatment outcomes. In her spare time, she enjoys spending time with her family. 

Thanks to our HealthTree Community for Chronic Lymphocytic Leukemia Sponsors:

Abbvie
Genentech

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