Fludarabine and Cyclophosphamide
With or Without Rituximab for Newly Diagnosed Mantle Cell Lymphoma
Introduction
Mantle cell lymphoma is a rare form of cancer that can affect the blood, bone marrow, lymph nodes and bowel.
There has been no standard treatment for this disease and many different types of chemotherapy have been used
in various combinations.
What is the aim of this trial?
This trial compares a combination of two chemotherapy drugs called fludarabine and cyclophosphamide with fludarabine,
cyclophosphamide and another drug called rituximab to see which combination is more effective for a person who
is newly diagnosed with mantle cell lymphoma.
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 over 18
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You have a confirmed diagnosis of mantle cell lymphoma
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Your blood test results are okay
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You are not pregnant
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You have not had chemotherapy in the past
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If you are 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 pregnant or breastfeeding
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If you have had cancer in the last five years, apart from non-melanoma skin cancer or in situ carcinoma of
the cervix
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If you have already received treatment for your mantle cell lymphoma
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If you have had chemotherapy in the past
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 two groups.
The first group
have fludarabine and cyclophosphamide tablets once a day for 3 days, every 4 weeks. Each 4 weeks
are called a cycle.
The second group
have fludarabine, cyclophosphamide and rituximab. The fludarabine and cyclophosphamide are taken
as tablets once a day for three days. The rituximab is given once through a drip into a vein. As with the first
group this is given every four weeks. Each 4 weeks are called a cycle.
Regardless of which group you are in you will have a blood test before each treatment and a number of tests done
after four cycles. This is to determine how well the treatment is working for you. If it is working well and you
can manage the side- effects you may have up to eight cycles. If the treatment is not working so well or the side
effects are severe your doctor may stop the treatment.
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 need treatment straight away or whether treatment can be delayed if you are
otherwise well.
The investigations 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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Chest x-ray
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Physical examination
Side effects
Fludarabine and cyclophosphamide have a few side effects but the most common are:
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Reducing your blood cell count which can make you more at risk of infection, or bleeding or feeling breathless
and tired
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The drugs can make you feel sick
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You may lose your appetite
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You may lose your hair but this is uncommon with these drugs. if you do lose your hair it will grow back
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