A study looking at a drug called alisertib in people with peripheral T cell lymphoma that has come back or continued to grow after treatment (LUMIERE)

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 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 Open a glossary item.

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 enzyme Open a glossary item), 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

  • See how well people respond to alisertib compared to other treatment for peripheral T cell lymphoma
  • See if alisertib can control your cancer

Who can enter

You may be able to enter this study if

  • You have a type of lymphoma called peripheral T cell lymphoma Open a glossary item
  • Your lymphoma can be measured by a physical examination and scans
  • You have had at least one type of standard chemotherapy Open a glossary item for your lymphoma but it has come back after treatment, or got worse
  • You have a sample of your cancer stored by the hospital when you were diagnosed, or you would be willing to give a sample (a biopsy) of your lymphoma for the study
  • You are willing to use 2 reliable forms of contraception from the start of the study until 30 days after the last dose of study treatment if you are female and there is any chance you could become pregnant, or for 6 months if you are male and there is any chance your partner could become pregnant
  • You have veins that the team would easily be able to take blood from (for people who join the chemotherapy group)
  • You have satisfactory blood tests
  • Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • You are at least 18 years old

You cannot enter this study if you

  • Have lymphoma that only affects your skin
  • Have lymphoma that affects your brain or spinal cord (your central nervous system)
  • Have had chemotherapy, radiotherapy, immunotherapy or any other experimental cancer drug in the last 4 weeks (6 weeks if you had nitrosourea chemotherapy Open a glossary item)
  • Have had radiotherapy to more than a third of your bone marrow Open a glossary item (if you have had radiotherapy to your whole body before a stem cell transplant you may still be able to take part)
  • Have had a stem cell transplant using your own blood cells in the last 3 months, or ever had a transplant using other people’s stem cells or body organs
  • Have had a drug similar to alisertib before, or have had both pralatrexate and gemcitabine chemotherapy (if you have only had one of these chemotherapy drugs, you may still be able take part)
  • Have had injections of growth factors or a transfusion of platelets in the last 2 weeks
  • Are taking drugs that would affect the action of proteins in the body called enzymes Open a glossary item, including drugs called CYP3A4 inhibitors – you can ask your doctor about this
  • Have taken steroids in the last 7 days (if you have been taking a low dose of prednisone for the last month, or you are taking steroids for sickness, skin conditions or asthma, you may still be able to take part)
  • Still have treatment side effects from earlier treatment, apart from hair loss (if the team think that your side effect would not make it unsafe for you to take part you still may be able to join)
  • Have had any other cancer, apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated at least 3 years ago
  • Are taking warfarin (if you are taking a low dose of warfarin or another blood thinning drug to stop clots in a central line you may still be able to take part)
  • Are taking a drug to reduce stomach acid and cannot stop taking it
  • Have had a stroke in the last year
  • Have a serious heart problem
  • Have had major surgery in the last 2 weeks
  • Have any condition that could make you very sleepy during the day, such as stopping breathing during sleep (sleep apnoea), or a group of conditions that cause difficulty breathing, called chronic obstructive pulmonary disease (COPD)
  • Have an infection needing antibiotics
  • Have an active infection of hepatitis B, hepatitis C or HIV
  • Are not able to swallow medication for any reason
  • Are pregnant or breastfeeding
  • Have any other condition that may make you unwell if you took part, or affect the results of the study – you can ask your doctor about this

Trial design

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.

LUMIERE study diagram

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.

Hospital visits

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

  • Heart traces (ECGs)
  • CT scans
  • PET scans

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.

Side effects

In the UK, pralatrexate is not a standard treatment for peripheral T cell lymphoma. Common side effects of pralatrexate include

  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • High temperature (Fever)
  • Constipation
  • Dizziness and fainting
  • Itching
  • Swelling due to a build up of fluid in your body (oedema)
  • Sore mouth
  • Tiredness (fatigue)
  • Cough
  • Nosebleed

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

  • Feeling and being sick
  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • Changes to the way your liver works
  • Protein or blood in your urine
  • Fever
  • Skin rash
  • Itching
  • Shortness of breath

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.

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr. Eve Gallop-Evans

Supported by

Experimental Cancer Medicine Centre (ECMC)
Millennium: The Takeda Oncology Company
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 9556

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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