Watch and Wait
Rituximab Versus a Watch and Wait Strategy in People With Advanced Stage,
Asymptomatic, Non-Bulky Follicular Lymphoma
Introduction
Follicular lymphoma is a type of Non Hodgkin's lymphoma. This type of lymphoma normally grows slowly over a long
period of time. Because of the 'indolent' nature of the disease the standard management for patients who have the
disease but as yet have no symptoms is simply for the doctor to watch the patient carefully and wait until the
first signs of disease before introducing chemotherapy.
Current understanding is that the longer the doctor can watch and wait before introducing chemotherapy the better
for you as this leads to an improved quality of life and better overall outcomes.
What is the aim of this trial?
This trial looks at two things. Firstly, the trial aims to compare early treatment with rituximab and watchful
waiting to see which approach is better at delaying the onset of symptoms which may lead to you needing chemotherapy.
Secondly, the trial looks at whether immediate treatment with rituximab or watching and waiting has an effect on a
person's quality of life.
Who can enter this trial?
You may be asked to enter this trial if you meet the following criteria:
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You are aged 18 or over
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You have a confirmed diagnosis of non-bulky follicular lymphoma
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Your blood test results are okay
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You have not had treatment for another cancer in the last 2 years apart from non-melanoma skin cancer or in
situ carcinoma of the cervix
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If you are in the group receiving treatment and of child bearing age you must agree to use barrier contraception
such as condoms during and after the trial for six months
What might stop me from entering this trial?
You won’t be asked to enter this trial for the following reasons:
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If you have a serious medical condition
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If you are experiencing 'B' symptoms such as itching, sweating and fevers
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If you are pregnant or breast feeding
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If you have had a previous cancer, unless it was successfully treated more than 2 years ago
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If you have already received treatment for your lymphoma
Do I have to take part?
No. You are a key member of the health care team and it is completely up to you whether you want to be involved in
this trial. You have a right to say no or withdraw at any time without your ongoing care or treatment being affected.
If you do choose to take part you will be given lots of information and asked to sign a consent form.
How is this trial run?
This trial is known as a randomised control trial. A randomised control trial is a trial in which patients with
similar disease traits are selected by a computer to be placed in different groups that are comparing different
treatments. There is no way at the time for researchers to know which of the treatments is best and neither you
nor your doctor get to choose which treatment you have.
In this particular trial there are three groups.
The first group
are carefully monitored by their doctor. This is the group receiving 'watchful waiting'.
The second group
are given rituximab through a drip into a vein once a week for 4 weeks. After this they revert to
'watchful waiting'.
The third group
follow the pattern of the second group of receiving rituximab through a drip into a vein once a
week for 4 weeks. After this treatment the third group receive what is known as ‘maintenance’ rituximab treatment.
The people in this group will continue to have rituximab treatment through a drip into a vein every 2 months for
approximately 2 years.
If you are in the second or third group you will have a CT scan after your fourth treatment with rituximab. This
is to determine how well the treatment is working for you.
Regardless of which group you are in you will be carefully monitored by your doctor. Your doctor will physically
examine you regularly and make a point of asking how you are and how your treatment and disease are affecting your
life. If at any time during the trial your disease shows signs of progressing or you are having symptoms your doctor
will stop the trial and start you on more appropriate treatment usually in the form of chemotherapy and/or
radiotherapy.
What might being entered in this trial mean to me?
Tests and hospital visits
Before you enter the trial you will have a number of tests to see how wide spread your disease is. This will tell
your health care team whether you are eligible for the trial or not.
The investigations may include:
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A CT scan
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Blood tests
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A bone marrow biopsy
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Physical examination
All patients regardless of which group they are in will be seen one month after starting the trial. After that
you will see your doctor every two months for two years, then every three months for the duration of the trial.
Side effects
Obviously, only the people in the second and third groups will receive treatment. As with many treatments there are
a number of side effects which you should know about. Your doctor or nurse can give you much more detailed
information on these effects and how you might manage them.
Rituximab has a few side effects which tend to happen during the actual treatment or very soon afterwards. These may include:
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Chills and fever
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Headache
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A rash which might become itchy
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It can sometimes make you feel sick