What are clinical trials?

Any potential treatments for Follicular Lymphoma (and other forms of Non-Hodgkin lymphoma) must undergo extensive testing. They must be fully researched to confirm that they work, are safe to use, and are more effective than other current treatments. 

Clinical trials test the treatment’s effects on human participants and are split into four phases. By joining a clinical trial, you may be able to try a therapy that is not yet available to the general public.  

It’s vital to ensure that a specific trial is suitable for you. If you’re interested in taking part, the best thing to do is to speak to your cancer specialist. As they have your records and test results, they can guide you on which Follicular Lymphoma clinical trials are safe and appropriate for you. Trials may be available through your haematologist’s or oncologist’s office or center, or may require travel to a different center. You’ll need a medical referral.

The four phases of clinical trials represent different stages of a treatment’s development.

Phase I trials are the earliest phase, designed to select the best dose and schedule of giving a drug or combination. It is important to understand that there is wide variability within phase I trials; not all are for new drugs just beginning development. Some Phase 1 trials, for example, test a combination of established drugs so much more would already be known about their safety and efficacy. These types of questions can be answered by the clinical trial team. Phase II trials most commonly test a new treatment (or combination) for a disease. In lymphoma studies, sometimes the disease will be limited to FL, while other trials may include all indolent lymphoma types or even other types. Generally, you and your doctor will know what treatment you are receiving in Phase I and II trials. Phase III studies are randomized comparisons of a standard therapy arm (also called cohort) with an experimental treatment arm (or arms), which might be adding something to or replacing standard treatment. You will be randomly assigned to one of the arms. Depending on the trial you may or may not know what arm you are on. To avoid bias, studies that are designed to test whether adding a drug to standard therapy is of benefit may include a placebo control for the experimental drug, but it is important to know that in such trials you will still be getting standard treatment. In FL, there are times when you may not need treatment, i.e. standard care is observation. In those cases, a Phase III trial might be designed to see whether earlier treatment is helpful, in which case there may be a no treatment arm, but that would be the normal approach for you at that point in time. This will be carefully explained to you by the study team and in the informed consent document. Phase IV trials are done after a treatment has been approved for your disease and might be designed to get more information about the treatment, such as side-effects..

What you need to know before taking part in a clinical trial

If you and your doctor decide that a Follicular Lymphoma clinical trial is a good option for you, the researchers will explain the treatment, how it is given and where , for example whether or not you’ll have to stay in hospital. 

They also have a legal and ethical obligation to tell you:

  • What the trial’s aim is.
  • What the different treatment groups are.
  • Potential benefits.
  • Likely risks and side effects – very new trials may not have a vast amount of information on side effects but it’s vital the researchers give you all the details they do already have.
  • What sorts of tests or checkups you’ll have throughout the trial.
  • How often you’ll need follow-up appointments.
  • Whether the researchers want to keep blood or tissue samples for future research.
  • Where your treatment will be.  

All of this information will be contained in the “Informed Consent Document” and Patient Information Sheet that must be given to you to read, review and then have the opportunity to ask questions about, and discuss with your family or other support systems if you want. After you sign the consent form, you will be given a copy of the signed form to keep as well.

 It’s important to remember that you can leave the trial at any time, and do not need to give a reason. If you choose to leave the trial, it won’t impact your ongoing care, however, you should always discuss this with your doctor to make sure that there is no interruption in your care .

What happens in Follicular Lymphoma clinical trials?

Joining a Follicular Lymphoma clinical trial usually starts with a discussion with the doctor and their clinical trial staff. They will explain the trial and answer any questions. If you agree to enroll in the trial, you will sign an informed consent form. The team will also carry out screening, generally an exam, lab work (blood tests) and in some cases repeat scans, to make sure you fit the trial’s eligibility criteria. 

Once accepted, you’ll have an initial visit to again check your physical condition and possibly some additional testing. These checks will give them a baseline to compare with during and at the end of the trial. 

If the trial is a randomized design, you’ll be put into a group. Neither you or your doctor control which group you are in.  You’ll go through the steps of the treatment as outlined in the informed consent and have regular tests to check your progress, both for improvement in your FL and for any toxicity. Treatments usually continue for either a specified period of time or as long as your disease is not progressing, as long as there are no serious side effects, and this will be described in the consent form. After you finish treatment, there will be periodic evaluations, exams, blood work (blood tests) and scans to monitor you and your FL.

Our mission and FL trials

As a dedicated Follicular Lymphoma charity, we’re passionate about leading new and determined efforts to find cures for FL. Follicular Lymphoma clinical trials are an essential part of this. However, before taking part in one, it’s vital to make sure you have all the information you need.

Our Precision Medicine Programme aims to improve and speed up the development of new treatments and, ultimately, a cure. 

Please don’t hesitate to contact the Follicular Lymphoma Foundation and connect with the FLF community.