Purpose of trial
The aim of the trial is to find out whether masitinib alone works better in treating peripheral T-cell lymphoma (PTCL) that has come back or not responded to treatment than chemotherapy, or masitinib combined with chemotherapy. The trial also aims to find out more about the side effects of mastinib.
PTCL is a type of high-grade (fast-growing) non-Hodgkin lymphoma. It often spreads to other lymph nodes from where it started and is generally treated with chemotherapy.
This is a randomised trial with 3 treatment groups. Participants are randomised to receive either:
- Group 1 - masitinib and dexamethasone
- Group 2 - gemcitabine and dexamethasone
- Group 3 - masitinib, gemcitabine and dexamethasone.
You can’t choose which treatment you have and neither can your doctor. Treatments are assigned by computer and once this has happened you are told what treatment you have been allocated and given information about it.
Masitinib is a newer, targeted drug called a tyrosine kinase inhibitor or cell signal blocker. This means that it blocks chemical growth signals that lymphoma cells send, which help to keep them alive or encourage them to divide.
The combination of gemcitabine (a chemotherapy drug) and dexamethasone (a steroid) is a treatment doctors often use for PTCL that has come back or not responded well to treatment.
Masitinib and dexamethasone are tablets that you swallow. You have gemcitabine intravenously (through a drip into a vein).
In a cycle of treatment, you have the drug on some days for 3 weeks followed by a rest period of 1 week to allow your body to recover before the next cycle.
- Group 1 have masitinib tablets twice a day and dexamethasone tablets once a week.
- Group 2 have treatment once a week with dexamethasone tablets in combination with a gemcitabine drip.
- Group 3 have masitinib tablets twice a day. Once a week, you have dexamethasone tablets together with a gemcitabine drip.
If you are in one of the groups having gemcitabine, you have up to 6 cycles of treatment.
If you are in one of the groups taking masitinib, you can continue to take it after the 6 cycles of treatment until there are signs of your lymphoma growing or you have side effects that mean you can’t (or don’t wish to) continue to take it.
After you finish treatment in the trial, you see the study team every 12 weeks for a check-up.
The researchers collect data on how well the treatment works as well as its side effects.
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
Around 267 people are needed for this trial.
You may be able to enter if:
- You have peripheral T-cell lymphoma (PTCL).
- Your lymphoma is stage 2, 3 or 4.
- Your lymphoma relapsed or continued to grow after having chemotherapy.
- Your lymphoma is measurable by the tests used in the trial.
- You are well enough to look after yourself and are up and about more than 50% of your waking hours, even if you are not well enough to work.
- Your blood and other health test results are satisfactory.
- You and your partner are willing to use reliable contraception if there is any chance of you or your partner becoming pregnant.
- You are 18 or over.
You will not be able to enter if:
- You have any other type of lymphoma.
- Your lymphoma is in your central nervous system (CNS; brain and spinal cord).
- You have had a donor (allogeneic) stem cell transplant for PTCL.
- Your PTCL came back within 3 months of having high dose chemotherapy followed by infusion of your own stem cells (autologous transplant).
- You still have significant side effects from your previous treatment.
- You have (or have had) particular heart problems or very high blood pressure.
- You have HIV, Hepatitis C virus or Hepatitis B virus.
- You have had another cancer in the last 5 years, except certain localised cancers.
- You are pregnant or breastfeeding.
- You need surgery, radiotherapy or any other cancer drugs within 4 weeks of starting the study treatment.
- You are taking or have taken certain other drugs.
- Any of the study drugs are not suitable for you.
More information about this trial is available on the NHS Human Research Authority (HRA) website.