A trial of pralatrexate after CHOP chemotherapy for peripheral T 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

Lymphoma

Non-Hodgkin lymphoma

Status:

Closed

Phase:

Phase 3

This trial is looking at a drug called pralatrexate for peripheral T cell lymphoma that has responded to chemotherapy.

Peripheral T cell lymphoma (PTCL) Open a glossary item is a type of non Hodgkin lymphoma where blood cells called T cells become cancerous. Doctors usually treat this type of lymphoma with chemotherapy. One of the drug combinations they often use is called CHOP.

If your lymphoma responds to chemotherapy and gets smaller or goes away completely, you may not have any further treatment at that point. But your doctors will monitor you closely to look for signs of the lymphoma coming back or getting worse. They call this observation.

Researchers are looking for ways to improve treatment and in this trial they are looking at a chemotherapy drug called pralatrexate. The people taking part have peripheral T cell lymphoma that has responded to CHOP chemotherapy. Some will have observation. Some will have pralatrexate.

The aim of the trial is to see if there is a difference in how long it takes for lymphoma to come back or get worse in people having pralatrexate compared to people having observation.

Who can enter

You may be able to enter this trial if you

Have peripheral T cell lymphoma and tests show it is one of the subtypes being studied in this trial (the trial team can advise you about this)
Have had at least 6 cycles of CHOP or a similar type of chemotherapy and your lymphoma has got smaller or disappeared completely
Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
Have satisfactory blood test results
Are at least 18 years old
Are willing to use reliable contraception during the trial if you have pralatrexate and there is any chance you or your partner could become pregnant. Women must carry on using contraception for at least a month after the last dose of pralatrexate, men must carry on for at least 3 months

You cannot enter this trial if you

Have lymphoma that has spread to your brain or spinal cord (central nervous system) and this needs treating
Have already had chemotherapy (apart from CHOP) or radiotherapy for peripheral T cell lymphoma (there are some exceptions to this and the trial team can advise you)
Have already had pralatrexate or your doctors are planning for you to have any other treatment for peripheral T cell lymphoma during the time you will be in the trial
Have had steroids in the last 3 weeks unless it was a low dose (the trial team can advise you about this and it is important you don’t stop taking any medication without talking to your doctor)
Have had major surgery in the last 2 weeks
Have had any other cancer in the last 5 years, unless it was a very early stage and has been successfully treated (the trial team can advise you about this)
Have high blood pressure that can’t be controlled with medication or have certain heart problems (the trial team can advise you about this)
Have an infection that can’t be controlled with medication or any other medical condition that the trial team think could affect you taking part
Are having drugs to treat HIV, hepatitis B or hepatitis C

Trial design

This phase 3 trial will recruit more than 500 people around the world. It is a randomised trial. The people taking part are put into 1 of 2 groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

People in one group have pralatrexate. People in the other group have observation which is the standard treatment Open a glossary item for people with peripheral T cell lymphoma that has responded to CHOP There will be twice as many people in the pralatrexate group as in the observation group.

trial diagram

If you are in the pralatrexate group, you have the drug as an injection into a vein once a week for 3 weeks out of 4. It takes up to 5 minutes each time. Each 4 week period is called a cycle of treatment. As long as you don’t have bad side effects and your lymphoma doesn’t come back or start to get worse, or you decide that you don’t want to continue in the trial, you can have pralatrexate for up to 2 years.

People in both groups also have 2 vitamins. Every 8 to 10 weeks, you have a vitamin B12 injection into one of your large muscles, and you take folic acid tablets every day.

If you are in the observation group, you see the trial team every 4 weeks. You carry on having observation until your lymphoma comes back or starts to get worse. Or until you start another type of treatment or you decide that you don’t want to continue in the trial.

Hospital visits

Before you can join the trial, the researchers will ask you to sign a consent form Open a glossary item . They also need to check that your lymphoma is definitely one of the types being studied in this trial. To do this, they get a sample of your lymphoma that was removed when you had a biopsy to diagnose your lymphoma. It can take a few weeks to check this. You don’t need to have a new biopsy.

If the tests on your lymphoma show that you can join the trial, you see the trial team and have some tests, including

Physical examination
Blood tests
CT scan
Heart trace (ECG )
Bone marrow test

You may also have a PET scan and if your lymphoma is affecting your skin, the trial team may take photographs of it.

If you are in the pralatrexate group, you go to hospital for treatment 3 times in each 4 week treatment cycle. You have a blood test before each injection of pralatrexate. Some people will be asked to have extra blood tests to see what happens to the drug in the body.

If you are in the observation group, you go to see the trial team and have a blood test every 4 weeks. And in the 2nd week of each 4 week period, a member of the trial team will phone you to see how you are.

Everybody taking part has a follow up visit and a CT scan 8 weeks after beginning the study. There is another visit 4 weeks later. You then have follow up visits every 12 weeks for 3 years. After 3 years, further follow up visits will be every 24 weeks for 4 more years. You may also have MRI scans, PET scans, bone marrow tests and skin photographs at these follow up visits.

You see the trial team again about a month after finishing pralatrexate or observation. The trial team will keep in touch with you for up to 7 years after you join the trial. Someone from the team will phone you to find out how you are and whether you are having any other treatment.

Side effects

As pralatrexate is a new drug, there may be side effects we don’t know about yet. In earlier trials, the most common side effects have been

Sore mouth
Tiredness (fatigue)
Feeling or being sick
Diarrhoea
High temperature (fever)
Shortness of breath
Constipation
A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Hair loss