A trial looking at vistusertib for diffuse large B cell lymphoma (TORCH)

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

Cancer type:

Blood cancers
Hodgkin lymphoma
Lymphoma
Non-Hodgkin lymphoma

Status:

Closed

Phase:

Phase 2

This trial is looking at a new drug called vistusertib (AZD2014) for diffuse B cell lymphoma. It is for people with lymphoma that has continued to grow during treatment or has come back afterwards. Diffuse large B cell lymphoma (DLBCL) is a type of non Hodgkin lymphoma. It is the most common type of high grade non Hodgkin lymphoma.

More about this trial

Doctors usually treat DLBCL with chemotherapy and a drug called rituximab. Some people may have high dose chemotherapy Open a glossary item followed by a stem cell transplant Open a glossary item.

For many people, these treatments get rid of the lymphoma cells (get it into remission Open a glossary item). But sometimes the DLBCL does not go away, or it comes back after a period of remission. So doctors are trying to improve treatment for this group of people. In this trial, researchers are looking at a drug called vistusertib.

Vistusertib is a type of biological therapy Open a glossary item. It is cancer growth blocker. It stops signals that cancer cells use to divide and grow.

The researchers are also looking at having vistusertib alongside rituximab in a small number of people. Researchers think rituximab may help vistusertib to work better. But they don’t know for sure.

The aims of this trial are to

  • Find out If vistusertib helps people with diffuse large B cell lymphoma
  • Find out if vistusertib and rituximab together is a useful and safe treatment
  • Learn more about the side effects

Who can enter

The following bullet points list the entry conditions for this trial. If you are unsure about any of these speak with your doctor or the trial team. They will be able to advise you.

You may be able to join this trial if all of the following apply.

  • You have DLBCL that either continued to grow or has come back despite treatment with chemotherapy and rituximab or another drug called obinutuzumab, or your lymphoma has changed (transformed) from low grade Open a glossary item - the changed lymphoma must have been treated 
  • You have had high dose chemotherapy and a stem cell transplant Open a glossary item with your own stem cells or you weren’t suitable to have one
  • You have lymphoma that can be measured on a scan and at least one area measures more than 1.5cm across, or you have an enlarged spleen that measures more than 14cm long
  • The trial team can test a sample of tissue (biopsy Open a glossary item) taken when you had a biopsy of your lymph nodes Open a glossary item
  • You have satisfactory blood test results
  • You are well enough to be up and about for at least half the day (performance status 0, 1, or 2)
  • You are willing to use 2 different types of reliable contraception while you are taking the trial drug and for up to 1 months afterwards, and for at least 1 year if you are having rituximab, if there is any chance that you or your partner could become pregnant
  • You are at least 18 years old

You cannot join this trial if any of these apply. You

  • Have lymphoma in your brain or spinal cord
  • Have had any lymphoma treatment in the 2 weeks before joining the trial such as chemotherapy, biological therapy, thalidomide Open a glossary item or radiotherapy Open a glossary item
  • Have had treatment with drugs called rapamycin, sirolimus, temsirolimus, everolimus, vistusertib or AZD8055 in the past
  • Have had severe side effects from drugs called PI3 kinase inhibitors or AKT inhibitors such as idelalisib and buparlisib in the past
  • Take other medication that can affect body substances called CYP enzymes or drugs that can alter your heart beat
  • Can’t swallow tablets for any reason
  • Have any moderate side effects from treatment that haven’t resolved apart from hair loss
  • Have had major surgery in the last 4 weeks
  • Have had a heart test called an ECHO Open a glossary item or MUGA Open a glossary item that showed a problem with how your heart pumps blood around your body
  • Have had a heart condition called torsades de pointes in the last 12 months
  • Have type 1 diabetes or type 2 diabetes that isn’t well controlled with medication
  • Have had a heart attack in the past 6 months, heart pain (angina), chronic congestive heart failure (CCF) or another serious heart condition
  • Have had problems with your digestive system Open a glossary item that may interfere with how you absorb the trial drug
  • Are allergic to vistusertib
  • Have any other medical condition or mental health problem that the trial team think would affect you taking part in this trial
  • Are known to be HIV, hepatitis B or hepatitis C positive
  • Are pregnant or breastfeeding

As well as the above, if you are having rituximab, you cannot join if you

  • Are known to be very sensitive to rituximab
  • Have had a live vaccine Open a glossary item in the last 4 weeks or plan to have one during the trial

Trial design

This is a phase 2 trial. The researchers need 36 people to take part in total.

The trial is in 2 parts. 30 people are needed for part 1 and 6 people for part 2.

Everyone has vistusertib. The people in part 2 also have rituximab.

Vistusertib is a tablet. You take it twice a day. You have treatment for the first 2 days of each week and then 5 days without treatment. You have treatment for as long as it is helping you and the side effects aren’t too bad.

If you join part 2, you also have rituximab as a drip into a vein once a month for up to 6 months. It takes about 1 to 2 hours each time.

The researchers will also ask for extra blood samples and a sample of spit (saliva). They will use these samples to find out more about diffuse large B cell lymphoma. If you don’t want to give these samples for research, you don’t have to. You can still take part in the trial.

Hospital visits

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

  • A physical examination
  • Blood tests
  • Urine tests
  • Heart trace (ECG Open a glossary item)
  • Heart scan such as an ECHO Open a glossary item or MUGA Open a glossary item
  • PET-CT scan

If you haven’t had a tissue sample (biopsy Open a glossary item) taken of your lymphoma in the last 3 months you will need one before you are able to take part in the trial.

If you are having rituximab, you go to hospital to have it.

For the first 6 months of treatment, you go to hospital once or twice a month for a check up. After that you see the trial team once a month.

You have a PET-CT scan 2 months and again 6 months after starting treatment.

A month after finishing treatment, you see the trial team for a check up. They will repeat some of the tests you had before you joined the trial.

The trial team will follow you up every 3 to 4 months for a year to see how you are getting on. You have a CT scan at each check up.

Side effects

As vistusertib is a new drug, there may be some side effects we don’t know about yet. The trial team will monitor you during the time you have treatment and you will be given a phone number to call them if you are worried about anything.

The most common side effects of vistusertib so far include

  • Loss of appetite
  • Tiredness (fatigue)
  • Feeling or being sick
  • Diarrhoea
  • Sore mouth or mouth ulcers
  • Tummy pain
  • Skin rash
  • Low level of potassium or phosphate in your blood
  • Confusion
  • High blood pressure
  • Muscle weakness
  • Feeling thirsty all the time
  • Problems concentrating
  • Passing urine more often

It is possible that vistusertib may make you more sensitive to sunlight. You should avoid strong sunlight, sunbeds and tanning booths during treatment and for 3 months after your last treatment.

We have information on the side effects of rituximab.

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 Graham Collins

Supported by

AstraZeneca
Bloodwise
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Birmingham

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12249

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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