A trial looking at fostamatinib for diffuse large B cell lymphoma

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

High grade lymphoma

Non-Hodgkin lymphoma

Status:

Closed

Phase:

Phase 2

This trial is looking at a new drug called fostamatinib to treat diffuse large B cell lymphoma (DLBCL) that has continued to grow during treatment (refractory) or come back after treatment (relapsed).

Fostamatinib is a type of biological therapy. It is a cancer growth blocker. We know from research that it may block one of the signals that lymphoma cells need to grow and divide.

The aims of this trial are to find out

If fostamatinib helps people with diffuse large B cell lymphoma
What is the best dose to use
What the side effects are
How it works in the body

Who can enter

You may be able to enter this trial if you

Have diffuse large B cell lymphoma that has continued to grow during treatment or come back after treatment
Have a lymph gland, or a lump (nodule) on your spleen or liver that is at least 1½ cm across and can be measured on a scan
Have a small piece of tissue (biopsy ) taken from your lymph gland or the lump on the spleen or liver, or you had a biopsy taken and frozen when your lymphoma came back as long as this is within 6 weeks of agreeing to take part in this trial
Have a tissue sample stored from previous surgery or a biopsy, that the researchers can use – your doctor can confirm this
Have satisfactory blood test results
Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
Are willing to use reliable contraception 2 weeks before treatment, during treatment and for 2 weeks afterwards if you or your partner could become pregnant
Are able to swallow tablets
Are at least 18 years old

You cannot enter this trial if you

Have lymphoma of the brain or spinal cord (central nervous system)
Are able to have high dose chemotherapy followed by a stem cell transplant
Have had treatment within 3 weeks of starting treatment as part of this trial (within 6 weeks for nitrosoureas and mitomycin C)
Have had radiotherapy to a large area within a month or to a small area to relieve symptoms within 2 weeks of starting treatment in this trial
Have had an experimental drug as part of another clinical trial within a month of starting treatment in this trial
Have had fostamatinib before
Still have side effects from previous treatment, apart from hair loss, unless they are very mild
Have high blood pressure that isn’t controlled
Have had another cancer in the past 2 years that your doctor thinks has a high risk of coming back
Have HIV, hepatitis B or hepatitis C that is causing problems
Have had a heart attack, stroke or heart pain in the past 6 months, or have any other serious heart problems
Have a blood clot that is causing symptoms and needs any treatment apart from medication that thins your blood
Have any condition that would stop you being able to swallow or absorb the trial medication
Are allergic to fostamatinib, or similar drugs, and their ingredients
Have another medical condition that could affect you taking part in this trial
Are pregnant or breastfeeding

Trial design

This is an international phase 2 trial. It will recruit at least 60 people from different countries. This is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in either. This is called a double blind trial.

Everyone will have fostamatinib. Half the people will have one dose. The other half will have double the dose.

Looking at fostamatinib for DLBCL trial diagram

Fostamatinib is a tablet. You take it twice daily. You can take it with or without food. You can continue taking fostamatinib as long as it is helping you and the side effects aren’t too bad.

As a part of this trial, the researchers will take a blood sample to look at the genetic makeup of a certain protein in your body. This is to find out how your body deals with fostamatinib.

If you agree to take part in this study, the researchers will ask for a sample of tissue before you start treatment and another if your lymphoma starts to get worse while having treatment. They will also ask for a blood sample. If you don’t want to give the tissue samples, blood sample or both for this study, you don’t have to. You can still take part in the trial.

Hospital visits

The researchers will ask your permission to access tissue from your tumour that has been stored from previous surgery or biopsy. You must agree to this. If you don’t you can’t take part in this trial.

You see the doctor to have some tests before taking part in this trial. These tests include

A physical examination
Blood tests (including the genetic test)
Urine test
Heart trace (ECG )
Bone marrow test
CT scan or PET scan

You see the doctor regularly during treatment and again a month after you stop taking fostamatinib. At these appointments, you have the same tests as above, apart from the bone marrow test.

Side effects

The most common side effects of fostamatinib are

Diarrhoea
Tiredness (fatigue)
A drop in blood cells causing an increased risk of infection, bruising or bleeding
High blood pressure
Headache
Dizziness
Shortness of breath
Cough
Fever
Feeling or being sick (nausea)