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Clinical trials are part of medical research, and their purpose is to discover if a new treatment or procedure is safe, has side effects, or is more effective than the current treatment. In this issue, we will focus upon one current study that is for patients who require treatment for chronic lymphocytic leukaemia (CLL). If you are interested in taking part in a clinical trial, your consultant and specialist nurse will discuss some of the options for you.
The study is for patients who have CLL and who have not received any prior treatment. The trial is called FLAIR, and is a Phase 3 study comparing a drug called ibrutinib alongside rituximab (IB). The standard treatment is fludarabine, cyclophosphamide (chemotherapy) with rituximab (monoclonal targeted therapy). This study is being carried out in around 100 hospitals in the UK and is expected to take 12 years to complete.
The FLAIR trial has recently been updated, and will now include a new treatment option called venetoclax, which is currently being assessed in other clinical studies. Patients who choose to participate and are eligible to enter the study will be randomly selected (by computer) to receive one of the four treatment options.
Not all patients will be able to enter the study; your doctor will discuss this with you. One of the questions that patients sometimes ask about random treatment selection is: Will I know which treatment I will be receiving? Patients who are randomised within the study will be told which treatment they will have.
The treatments that are being studied in this trial include:
Chemotherapies
– Fludarabine
– Cyclophosphamide
This treatment is given for a total of six courses. Each treatment cycle lasts for five days and the treatments are repeated every four weeks. Your blood counts will be monitored and your doctor will explain if we need to delay any treatments if your blood counts are too low to go ahead. Usually, this trial treatment is given in tablet form.
These treatments are also given alongside rituximab, which is a biological therapy called a monoclonal antibody. This is given as an injection, which will take some time to deliver. Patients will need to attend day care unit for this drug to be administered.
This combination of treatment is called FCR. It is the standard treatment and is option one in the trial.
Biological Therapy
– Ibrutinib
Ibrutinib is a biological therapy called a cancer growth blocker. It works by stopping signals that cancer cells use to divide and grow. This is given as a tablet and you will need to take three capsules every day for up to six years. You may stop and restart depending on your blood tests and how your CLL is responding to the treatment. Your doctor will explain this before and during the study.
This will be given in combination with rituximab (an injection given at the hospital). This combination is called IB, which is option two.
The next option of treatment that is available (option three) is that patients will receive ibrutinib alone without any combination treatment.
Again, this is given as a daily medication of three capsules each day for up to six years. You will need to attend clinic for your first course, and following this, you will be able to take ibrutinib at home. You will need to attend clinics regularly to see your doctor, who will monitor your blood tests.
Venetoclax
Venetoclax is another type of biological therapy. It works by blocking the functions of a protein found in CLL cells, and this causes these cells to die. This therapy is a new treatment addition to the FLAIR trial. The drug is currently being used and assessed in other studies for CLL for those patients who have already had treatment previously.
We are now looking at the benefit of venetoclax being used as first line therapy and comparing the benefits against the other three treatment options.
Venetoclax is taken as a tablet and the dose will be gradually increased.
Once you are receiving the highest dose, you will be taking four tablets each day. For the first day of each increasing dose, you will need to be admitted to hospital. This is so your blood tests can be closely monitored. Once you are on the highest dose, you will be able to take these tablets at home.
This treatment will be given along with ibrutinib and is treatment option four. It is called I+V.
Your Doctor and specialist nurse will explain how the combination will be given and how many hospital visits you will need to attend.
During the study, we will need to take some blood and bone marrow samples, regardless of the treatment option that you will receive.
These are called trial specific tests that will be completed to monitor your progress during the study. These tests are in addition to your normal blood samples that will be required prior to each course of your treatment.
These tests will include:
Minimal Residual Disease (MRD): everybody who is diagnosed with CLL will have detectable levels of CLL in their blood and marrow before starting treatment. This is known as MRD. These blood tests will be taken to measure these CLL levels throughout the trial.
CT Scans: patients who participate in this trial will be required to have CT scans at certain time points during the study.
All of the trial tests are necessary to monitor your progress and response to the treatment options. During your clinic appointment, a full discussion about this study will be provided by your Consultant and specialist nurse. You will also be provided with some information to take away to read with your family and friends.