A trial of ibrutinib and rituximab for post-transplant lymphoproliferative disorder (TIDaL)

Cancer type:

Blood cancers
Lymphoma
Secondary cancers

Status:

Open

Phase:

Phase 2
This trial is looking at the combination of ibrutinib and rituximab for people who develop a condition called post-transplant lymphoproliferative disorder.
 
Post-transplant lymphoproliferative disorder can develop after a:
  • stem cell transplant, a treatment used for some types of cancer
  • an organ transplant Open a glossary item, such the heart, lung or liver

More about this trial

After a transplant, if your immune system isn’t strong enough a type of white blood cell called B cells might grow out of control. This is post-transplant lymphoproliferative disorder (PTLD).
 
The initial treatment for PTLD is a targeted drug called rituximab. This works very well for about 25 out of every 100 people (25%). 
 
For people where rituximab by itself doesn’t work well chemotherapy is added. The standard treatment for these people is a combination called R-CHOP:
 
rituximab (R)
cyclophosphamide (C)
doxorubicin (H)
vincristine (O)
prednisolone (P)
 
R-CHOP does work. But there is a high risk of:
  • getting an infection
  • damage to the transplant
  • side effects 
We know from research that ibrutinib by itself or in combination with rituximab works for a type of cancer called lymphoma Open a glossary item
 
In this trial everyone has ibrutinib and rituximab as their first treatment. After a number of weeks of treatment, the researchers look at how well this has worked. 
 
If it has worked well, you continue to have ibrutinib and rituximab. If it hasn’t worked so well, you have ibrutinib and R-CHOP.
 
The aims of this trial are to find out:
  • how well ibrutinib and rituximab work as initial treatment for PTLD
  • if adding ibrutinib to R-CHOP works better
  • about the side effects of these treatments

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 
 
Who can take part
 
You may be able to join this trial if all of the following apply:
  • you have post-transplant lymphoproliferative disorder (PTLD) that has the CD20 protein
  • you haven’t had treatment for PTLD
  • you have an area of PTLD that can be measured and is greater than 2cm and, or your bone marrow has been affected by PTLD
  • you have had a donor stem cell transplant and the PTLD developed more than 6 months afterwards or you have PTLD because you have had a transplant of your heart, lung, liver, kidney, pancreas or small intestine
  • you have satisfactory blood test results
  • your heart works well enough, you have a test for this
  • you are up and about, can look after yourself but can’t work (performance status 0, 1 or 2)
  • you are willing to use reliable contraception during the trial and for up to a year after if you or your partner could become pregnant
  • you are at least 16 years old
Who can’t take part
 
You cannot join this trial if any of these apply. You:
  • have PTLD that has come back (relapsed) or continued to grow during treatment (refractory)
  • have had all the PTLD removed by surgery
  • have radiotherapy to any areas of PTLD that were left after surgery
  • have developed PTLD within 6 months of having a donor stem cell transplant
  • have PTLD that is caused by a type of white blood cell called T cells
  • have already had rituximab or chemotherapy treatment for your PTLD
  • need to continue with a medication, including herbal medicines, that could affect how the treatments in this trial works
  • have had medication that thins your blood such as warfarin or a vitamin K blocker, within 1 week of being registered for this trial
  • have a severe problem with one or more of your body organs that isn’t due to PTLD
  • have HIV
  • have active hepatitis B or any other serious active infection that the trial team think could affect you taking part in the trial
  • have an allergy to any of the drugs used in this trial or there is another reason you can’t have them
  • are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The team need up to 60 people to join the trial. 

There are 2 stages of treatment in this trial.

Stage 1 
Everyone has ibrutinib and rituximab for up to 7 weeks. 

You then have a CT scan to see how well the treatment is working. 

Stage 2
What treatment you have in this stage depends on how well the treatment in stage 1 worked for you.

If treatment worked well, you continue with ibrutinib and rituximab. 

If it worked a little bit or didn’t work you have ibrutinib and R-CHOP. 

Ibrutinib is a capsule. You take 1 capsule a day at the same time at least 30 minutes before food or 2 hours after food. 
 
You have rituximab as a drip into a vein. You have it once a week for the first 4 weeks and then once every 3 weeks. 
 
R-CHOP is the standard treatment for PTLD. It includes the drugs:
  • rituximab
  • doxorubicin
  • cyclophosphamide
  • vincristine
  • prednisolone
You have rituximab, doxorubicin, cyclophosphamide and vincristine as a drip into a vein. You have them once every 3 weeks. 
 
Prednisolone is a tablet. You take it once a day for 5 days.
 
You can have up to 5 months of treatment in total. 
 
You have a diary to write down when you have your ibrutinib. You need to bring this to your hospital appointments for your doctor to see. 
 
While having treatment there are certain foods, drinks and medications you should avoid. These include:
  • grapefruit and its juice
  • Seville oranges and its juice
  • marmalade
  • St John’s wort
  • vitamin E
  • certain antibiotics
Your doctor will talk to you about this and give a full list of what to avoid. 

Hospital visits

You see your doctor to have tests before taking part in the trial. These tests include:
  • a physical examination
  • blood tests
  • heart trace (ECG Open a glossary item)
  • heart scan (ECHO Open a glossary item or MUGA Open a glossary item)
  • breathing test (lung function tests Open a glossary item)
  • CT scan
  • PET scan
  • MRI scan
  • bone marrow test
  • a tissue sample (biopsy) of the PTLD unless one was taken in the past 6 months and the team are able to obtain a piece of it
For stage 1 treatment
You see the doctor every week for a month for:
  • a physical examination
  • blood tests
At 7 weeks you see the doctor for:
  • a physical examination
  • blood tests
  • CT scan
  • breathing test
  • heart scan, if needed
For stage 2 treatment
You see the doctor every 3 weeks for:
  • a physical examination
  • blood tests
At 6 weeks you have more breathing tests. You might have another heart scan if your doctor thinks it is needed. 
 
At the end of treatment, you see the doctor for:
  • a physical examination
  • blood tests
  • heart trace (ECG)
  • heart scan (ECHO or MUGA), if needed
  • breathing test (lung function tests)
  • CT scan
  • PET scan
  • MRI scan
  • bone marrow test
After treatment you see the doctor every 4 months for 2 years to see how you are and for blood tests. You have a CT scan after 1 year. 

Side effects

Your doctor and nurse will monitor you closely for any side effects. Let your doctor or nurse know as soon as possible if:
  • you have severe side effects
  • your side effects aren’t getting any better
  • your side effects are getting worse
  • you notice anything unusual or anything that has changed
The most common side effects of ibrutinib include:
We have information about the side effects of:

Location

Birmingham
Cardiff
Coventry
Leeds
Leicester
Liverpool
London
Manchester
Newcastle upon Tyne
Nottingham
Oxford
Plymouth
Scotland
Sheffield
Southampton

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 Tobias Menne

Supported by

Bloodwise
Janssen
University of Birmingham

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15564

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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