Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial looking at lenalidomide for mantle cell lymphoma that has come back or is no longer responding to treatment (SPRINT)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at lenalidomide (Revlimid) for mantle cell lymphoma that is not responding to treatment or has come back after other types of treatment. You may hear this called refractory or relapsed mantle cell lymphoma.
Doctors often treat mantle cell lymphoma with chemotherapy. If mantle cell lymphoma comes back, doctors can choose from a few different cancer drugs to treat it with. But they are not sure which the best one is.
The aim of this trial is to compare lenalidomide with the cancer drugs already used to find out
- How well it works for people with mantle cell lymphoma
- How it affects quality of life
Who can enter
You may be able to enter this trial if
- You have mantle cell lymphoma that has continued to grow during treatment or has come back after treatment
- You have had at least 1 course of chemotherapy treatment
- Your chemotherapy included an
alkylating drugsuch as cyclophosphamide and either an anthracyclinesuch as doxorubicin or cytarabine or fludarabine
- You have a CT scan or MRI scan that shows your lymphoma is at least 2cm across
- You have satisfactory blood test results
- You are well enough to be up and about for at least half the day (performance status 0, 1, 2)
- You are willing to use reliable contraception if there is a chance you or your partner could become pregnant
- You are at least 18 years old
You cannot enter this trial if
- You have another type of lymphoma other than mantle cell
- You have lymphoma that has changed from low grade to high grade lymphoma
- Your lymphoma has come back (relapsed) more than 3 times during or after chemotherapy treatment
- You have lymphoma in your spinal cord or brain (central nervous system) unless it has been treated, has caused no symptoms in the past 3 months and you have a clear
- You are able to have
high dose chemotherapyand a bone marrow transplant
- You have had a bone marrow transplant from someone else and the cells are still working
- You have had lenalidomide before
- You have had radiotherapy in the last 4 weeks
- You have had steroids in the last 7 days apart from treatment for your mantle cell lymphoma
- You have had an experimental drug in the last 4 weeks
- You are taking part in another clinical trial
- You have had another cancer, unless it was successfully treated and there has been no sign of it (
complete remission) for at least 5 years apart from non melanoma skin cancer, carcinoma in situof the cervix or breast, or very early prostate cancer (stage 1)
- You are known to be HIV positive, hepatitis B or hepatitis C positive
- You have another serious medical condition that could affect you taking part in this trial
- You are pregnant or breastfeeding
This is a phase 2 international trial. It will recruit about 250 people from different countries around the world. It is a randomised trial. If you take part, you will be put into one of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
If you are in group 1 you will have lenalidomide. If you are in group 2 your doctor can choose a cancer drug to treat you with. They can choose one of the following
In case you are put into group 2, your doctor will make their choice before you are randomised.
Lenalidomide and chlorambucil are tablets. You take them once a day. You can have cytarabine as an injection just under the skin or as a drip into a vein. You have gemcitabine and rituximab as a drip into a vein. You can have fludarabine as a tablet or as a drip into a vein.
For lenalidomide, chlorambucil, gemcitabine, cytarabine and fludarabine each cycle of treatment is 28 days. For rituximab each cycle of treatment is 56 days.
How long you have lenalidomide, chlorambucil or rituximab depends on whether the treatment is helping you and how bad the side effects are.
You have cytarabine, gemcitabine and fludarabine for up to 6 cycles of treatment.
If you are having your doctor’s choice of treatment and it is not helping, you may be able to start taking lenalidomide instead. Changing groups like this is called a ‘cross over’. Your doctor will talk to you about this.
When you start lenalidomide, you will have some lymphoma cells in your body. When cancer cells die, chemicals in the cells are suddenly released into your blood. This changes the normal balance of chemicals circulating in your body. This is called tumour lysis syndrome. Your doctor will give you medication to control it.
You fill in a questionnaire before you start treatment, every 2 months for 8 months, and then at the end of treatment. It will ask how you are feeling and what activities you can do.
Before you start the trial, you will see the doctor and have some tests. These include
- A physical examination
- Blood tests
- Heart trace (
- CT scan or MRI scan
- Biopsy (if not done before)
During treatment you see the doctor every 4 weeks and have a physical examination and blood tests.
At the end of treatment you see the doctor and have
- A physical examination
- Blood tests
Every 2 months for 6 months and then every 3 months you have a CT scan or MRI scan. If one of these scans shows your lymphoma has continued to grow or come back you stop the study visits. Your doctor will then talk to you about how often they want to see you.
If you crossed over to lenalidomide you see the doctor every 3 months for a physical examination, blood tests and CT scan.
All treatments have side effects. The most common side effects of lenalidomide are
- Feeling tired
- A drop in blood cells causing an increased risk of infection, bruising , bleeding problems and shortness of breath
- Feeling sick
- Loss of appetite
- Back or joint pain
- Muscle cramps
- Shortness of breath
- Chest infections
- Difficulty sleeping
- Swollen arms or legs
- Rash or itchy skin
- Lack or loss of strength
- Blood clots
The most common side effects of gemcitabine, fludarabine, cytarabine, chlorambucil and rituximab are
- A drop in blood cells causing and increased risk of infection, bruising and bleeding
- Feeling or being sick
- Loss of appetite
- Flu like symptoms
- Tingling of the hands or feet
Your doctor will talk to you about other possible side effects before you agree to take part in this trial.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Prof Simon Rule
Experimental Cancer Medicine Centre (ECMC)