PARADIGME

A study about Follicular Lymphoma

THE PARADIGME STUDY

This research study is testing investigational treatments (Lilotomab and Betalutin®) to see how it works for people whose follicular lymphoma (FL) has returned.

Medical Condition: Follicular Lymphoma

Study duration: 5 years

Phase: IIb

Study locations: United States and Canada

How can I participate?

If your FL has returned, even though you have gone through treatment, you may qualify to participate.

You can take a short questionnaire by clicking here and if you pass, a nurse will call you to review more of your medical history.

More about Follicular Lymphoma:

Follicular lymphoma (FL) is a type of non-Hodgkin lymphoma (NHL) which are cancers impacting the lymphatic system in your body. The lymphatic system includes your lymph nodes, spleen, and bone marrow.

FL can spread to other tissues and organs after starting in the lymphatic system.

This type of cancer can develop slowly or rapidly. For many people, it is slow growing and develops over many years.

Source: https://rarediseases.org/rare-diseases/follicular-lymphoma/

What does it mean to participate in this trial?

Clinical trials are designed with the patient’s safety as the top priority but also to establish how a drug or drugs work best to treat your disease. If you choose to participate, you will be well informed throughout the process and have the option to withdraw at any time.

This study includes traveling to the study center 18 times over a maximum of 5 years and receiving medication at 2 of the visits.

Travel

Research centers are located in many areas of the United States and Canada for your convenience. If you feel that travel to the research center would be a burden, please discuss this with the staff at the study center. There may be an opportunity to help coordinate travel services or offer reimbursement for travel costs.

COVID

We are committed to doing our part to prioritize the health, safety, and support of our patients and our staff while we continue undertaking measures to help slow the spread of COVID-19 in our communities.

If you qualify and choose to participate in the PARADIGME research study, the research center will discuss your COVID-19 related concerns with you. There may be flexibility to have some assessments closer to your home – again, the research center will review this with you.

Frequently Asked Questions

What is a clinical study?

Clinical studies explore whether a medicine, treatment, or device is safe and effective for humans.

Clinical studies are scientific studies in which new medicines and treatments are tested to make sure they are safe and effective for people to take and use. They are one of the most important steps in bringing new treatments to patients.

Why is clinical research important?

Clinical research adds to medical knowledge and helps bring new treatments to people with medical conditions. In order to make new treatments available to the public they need be studied in clinical trials.

Clinical trials rely on the participation of volunteers in order to succeed. On average, it can take up to 8 years for a new treatment to reach the public, the major hold-up being how long it takes to complete the clinical trials (often due to shortage of participants).

All new medical treatments and drugs have gone through clinical trials to make sure that they are safe and effective.

Who runs clinical studies?
Clinical studies can be sponsored, or funded, by pharmaceutical companies, academic medical centres, voluntary groups, or health care providers.

Every clinical study is led by a principal investigator, who is often a medical doctor. Clinical studies also have a research team that may include doctors, nurses, social workers, and other health care professionals.

What are the phases of clinical research studies?

Clinical studies are conducted in different phases:

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the effect in various populations and any side effects associated with long-term use.

What does it mean to participate?

Taking part in a clinical trial typically involves taking tests to ensure you are a match for the study. If you qualify, you will visit the clinic regularly to receive the drug, treatment and assess your disease. The study staff will monitor your progress and well-being.

Before taking part in a trial, you are informed about what it means to participate in the study, including how the study is conducted, how you are protected during the study and the risks and benefits of participating. You may choose to end your participation in the study at any time.

You should learn about the risks and benefits of any clinical trial before you agree to take part in a trial. Talk to your doctor about specific trials you’re interested in.