
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at pembrolizumab and rituximab for Waldenstrom’s macroglobulinaemia (WM). It is for people whose WM has come back after treatment or treatment has stopped working.
(WM) is a slow growing type of
(NHL).
Doctors treat WM with rituximab on its own or in combination with other chemotherapy drugs or .
Sometimes WM can come back during treatment. This is known as refractory WM. It can also come back after treatment has finished. This is known as relapsed WM. Researchers are looking for new treatments to help people in these situations.
Pembrolizumab is an immunotherapy drug. It works by helping the immune system find and kill cancer cells. We know from previous clinical trials that pembrolizumab could help people with WM.
Rituximab is a monoclonal antibody.
Researchers think the combination of pembrolizumab and rituximab might help people with WM that has come back or treatment has stopped working.
The main aims in this trial are to find out:
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:
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
This is a phase 2 trial. The trial team need 42 people to join. Everyone has pembrolizumab and rituximab.
You have pembrolizumab as a drip into a vein. You have it once every 3 weeks.
You have rituximab as a drip into a vein. You have it once a week for 4 weeks. And then once every 12 weeks.
Your doctor checks how well treatment is working at:
You have treatment for a year as long as it is working and the side effects aren’t too bad.
Samples
You give some extra blood samples when you join and during the trial. When you have a the trial team take a small piece of the
The team ask to take a small piece of the lymph node tissue () if your cancer has spread to the
. You give this when you join the trial.
Researchers use these samples to find out more about Waldenstrom’s macroglobulinemia and the treatment.
Quality of life
You fill in a questionnaire when you join the trial and twice more during the trial. The questions ask about:
This is a quality of life questionnaire.
In the event of pregnancy
During the trial if you or your partner become pregnant you stop treatment.
And the trial team want to monitor any pregnancies that happen during the trial or after. They collect this information during the pregnancy and for 8 weeks after.
Women who become pregnant during treatment or within a year of stopping treatment, should tell their doctor or the trial team.
For men, if your partner becomes pregnant during treatment or in the 4 months after treatment has finished, tell your doctor or the trial team.
You or your partner don’t have to agree to have the pregnancy monitored by the trial team.
You see the doctor to have some tests before taking part. These include:
You have treatment at the hospital on the day ward. During treatment you see the doctor for the following tests:
You have these before each treatment and at:
You have a bone marrow test at weeks 24 and 52. You also have a CT scan if needed.
You see the doctor at 2 months and then every year after finishing treatment.
A member of the trial team phones you 5 months after finishing treatment to talk about any side effects you might have.
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
You have a contact card from the trial team with the number to call. You should carry this card with you all the time. And when you go to the GP or hospital show them the card. In case they need to contact the trial team.
Pembrolizumab and rituximab can affect the immune system. They may cause inflammation in different parts of the body which can cause serious side effects. These could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. If you have any of these side effects, you should tell the doctor or nurse as soon as possible that you are on or have been on an immunotherapy. |
The most common side effects of pembrolizumab and rituximab include:
We have more information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Jaimal Kothari
University College London (UCL)
Merck, Sharp & Dohme
CRUK & UCL Cancer Trials Centre
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”