
"I am glad that taking part in a trial might help others on their own cancer journey.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is comparing an experimental drug called alisertib with the chemotherapy drugs pralatrexate or gemcitabine, in people who have a type of cancer called .
Peripheral T cell lymphoma (PTCL) is a type of non Hodgkin lymphoma, where blood cells called T cells become cancerous. If you have PTCL, you may have treatment with chemotherapy. Sometimes though, the lymphoma can continue to grow during treatment, or come back after treatment.
Researchers in this study are looking at an experimental drug for PTCL, called alisertib. Alisertib can block a particular protein (an ), which may slow down cancer growth by killing the cancer cells.
This study will compare alisertib with the chemotherapy drugs gemcitabine or pralatrexate. The main aims of the study are to
You may be able to enter this study if
You cannot enter this study if you
This phase 3 study will recruit about 354 people. It is randomised. The people taking part are put into 2 treatment groups by a computer. There will be about the same number of people in each group. Neither you nor your doctor will be able to decide which group you are in.
If you are in group 1, you have alisertib tablets. You take alisertib twice a day, with water, 12 hours apart. You take it for 7 days and then have 2 weeks with no treatment. Each 3 week period makes up a cycle of treatment.
People taking part in the trial in the UK, who are in group 2, have either pralatrexate or gemcitabine. Which one you have is up to your doctor.
If you have pralatrexate, you have it as an injection into a vein once a week for 6 weeks and then a week with no treatment. Each 7 week period makes up a cycle of treatment. You also take folic acid tablets, starting 10 days before your first dose of pralatrexate, up until 30 days after your last dose of pralatrexate. And, you have vitamin B12 as an injection into a muscle, once during the 10 weeks before you start treatment, and then about every 10 weeks throughout treatment.
If you have gemcitabine, you have it through a drip into a vein, over about half an hour, once a week for 3 weeks and then a week with no treatment. Each 4 week period makes up a cycle of treatment.
You will have a number of blood tests and scans throughout the study. The team will tell you more about these. You will also fill out quality of life questionnaires before you start treatment, during the study and a couple of times at the end of treatment. The questionnaires will ask about side effects you may be having and how you’ve been feeling.
How long you stay in the study depends on how well your body copes with the drug you have, and the effect it has on your lymphoma.
Before you join the study, you see the doctor and fill out quality of life questionnaires. You also have some tests, including
The doctor may also take photographs of any areas of lymphoma they can see.
Throughout the study, you see the doctor and have regular blood samples. You also have
How often you have these depends on how long you stay in the study. You have the scans every 8 weeks until you have taken part for 10 months. Then you have scans every 12 weeks.
When you finish treatment, you see the team between 30 and 40 days later. You then see the doctor every 8 to 12 weeks for scans, physical examinations and blood tests, depending how long you were in the study. You do this until your lymphoma starts to get worse.
After this, your doctor will phone you every 4 months for about 42 months to see how you are getting on.
In the UK, pralatrexate is not a standard treatment for peripheral T cell lymphoma. Common side effects of pralatrexate include
In the UK, gemcitabine is not a standard treatment for peripheral T cell lymphoma. When used to treat other conditions, common side effects of gemcitabine include
Alisertib is still experimental, so there may be some unknown side effects. The most common side effects of alisertib include
The trial team will talk to you about all the possible side effects before you take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr. Eve Gallop-Evans
Experimental Cancer Medicine Centre (ECMC)
Millennium: The Takeda Oncology Company
NIHR Clinical Research Network: Cancer
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”