Lymphoma Treatment: Clinical Trials

by Linda Bartlett, NCI

Lymphoma patients may have the option to participate in clinical trials, gaining access to an experimental treatment before it is widely available. There are many factors to consider before deciding to participate in any type of clinical trial.

While the information presented here can answer general questions, be sure to speak with your health care professional and consult other resources such as clinicaltrials.gov, a service of the U.S. National Institutes of Health [NIH], before making any decisions.

What is a clinical trial?

Clinical trials are health-related research studies using human subjects. They follow a carefully defined protocol or study plan that is designed to answer specific research questions while protecting the health of trial participants. Despite precautions, clinical trials can pose significant risks.

There are several different types of clinical trials, including treatment trials, prevention trials, diagnostic trials, screening trials and quality of life or supportive care trials. They may be funded or sponsored by physicians, medical institutions, foundations, pharmaceutical companies or federal agencies, including the NIH and the Department of Defense.

Most treatment trials are conducted in three phases. Experimental treatments or drugs are given to a small group of 20 to 80 people in Phase I trials and then to progressively larger groups in Phases II and III.

Pros and cons of participating in a clinical trial

Participants in clinical treatment trials receive experimental treatments that are not widely available. Beyond the possible personal health benefits of the treatment, participants also can gain a sense of control over their health care and satisfaction from playing a part in medical research that has the potential to help others.

Disadvantages of clinical trials can include unpleasant or even risky side effects from the experimental treatment. Clinical trials typically require participants to commit significant time and attention either through additional site visits, recordkeeping and/or complex dosage instructions.

Participants may not realize any health benefits from the trial, either because the experimental treatment is ineffective or because the participant is a member of the clinical trial control group. In some trials, control groups receive either an inactive treatment known as a placebo or the standard treatment for the condition in order to establish a "control" against which the experimental treatment is measured.

Finding a suitable clinical trial

Your medical team or doctor should help you find clinical trials that may be suitable for your condition. Your general health, type of lymphoma, its stage and prior treatments are all factors to consider when searching for a clinical trial. Questions to ask about specific trials include:

• What is the purpose of the study?
• What type of experimental treatment is being tested?
• Why is this treatment believed to be effective?
• How will I know if the treatment is working? Will I see the trial results?
• How long will the trial last?
• How will it affect my daily life?
• Who will pay for the experimental treatment?
• Who will be in charge of my care? Will my doctor be involved?
• What type of follow-up care is involved?

Participating in a clinical trial

If you decide to participate and are accepted into a clinical trial, you will be asked to sign an informed consent document. The document includes details about the study including required procedures, duration, potential benefits, risks and key contacts. While you must sign an informed consent document to participate, you are free to withdraw from the trial at any time.

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Resources

• The National Cancer Institute's Clinical Trial Center
• For information about clinical trials taking place at the NCI/National Institutes of Health campus in Bethesda, Maryland, see the Bethesda Campus Clinical Trials site.
• Centerwatch is a resource both for patients interested in participating in clinical trials and for research professionals.
• The Coalition of National Cancer Cooperative Groups has a their TrialCheck^™ tool
• European Clinical Trials http://www.EORTC.be/

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