
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
This trial is looking at a drug called polatuzumab vedotin in combination with a treatment called RICE for B cell lymphoma.
It is open to people with diffuse large B cell lymphoma:
One treatment doctors can use to treat diffuse large B cell lymphoma (DLBCL) is RICE. This is a combination of a called rituximab and the chemotherapy drugs ifosfamide, carboplatin and etoposide.
Polatuzumab vedotin is made up of the monoclonal antibody polatuzumab and the chemotherapy drug vedotin. Polatuzumab targets a particular protein on B cell lymphoma cells. When polatuzumab attaches to these cells it delivers vedotin into the cell. Vedotin then kills the lymphoma cells.
We know from research that polatuzumab vedotin either by itself or in combination with chemotherapy drugs can help people with lymphoma.
Researchers think that polatuzumab vedotin in combination with RICE might help people when their initial treatment stopped working. Or when their DLBCL came back after initial treatment.
The main aims of this trial are to find:
The following bullet points are a summary of 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.
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 an international phase 3 trial. The team plan to have 324 people take part with up to 75 people from the UK.
It is a randomised trial. A computer puts you into 1 of 2 treatment groups. Neither you nor your doctor choses which group you are in. The 2 groups are:
You have treatment in cycles. Each is 3 weeks. You have 3 treatment cycles.
You have polatuzumab vedotin as a drip into a vein on the 1st day of each treatment cycle.
Whether you are having RICE as part of the trial or not you have it the same way. You have RICE as a drip into a vein. There are 4 drugs in RICE. They are:
You have rituximab on the 1st day of each treatment cycle.
You have ifosfamide on the 2nd day. You have it over 24 hours and stay overnight in hospital.
You have carboplatin on the 2nd day of each treatment cycle.
You have etoposide on the 1st, 2nd and 3rd day at the start of each cycle.
Samples for research
You give extra blood samples and tissue samples (biopsies) as part of the trial. Where possible the trial team take these samples when you have them done as part of your routine care.
They will use these samples to find out:
Researchers in the future might also use these samples.
You don’t have to agree to have these samples taken. You can still take part in the trial.
Quality of life
You fill in questionnaires:
These are quality of life questionnaires.
You see the doctor to have tests before taking part. These tests include:
You see the doctor regularly during treatment:
You have a PET-CT scan or CT scan during treatment and at the end of treatment.
You see the doctor at the end of treatment to see how you are and for blood tests. You then see the doctor every 3 months for at least 2 years after joining the trial.
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.
The combination of polatuzumab vedotin and RICE is new and the side effects aren’t yet known.
Polatuzumab vedotin is new and there might be side effects we don’t know about yet. The side effects reported so far include:
Below are other side effects reported by people having polatuzumab vedotin but it isn’t known if they are caused by polatuzumab vedotin. These include:
We have information about RICE and its side effects.
Your doctor will talk to you about possible side effects and answer any questions you have before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Andrew Davies
Cancer Research UK
F. Hoffmann - La Roche, Limited
Southampton Clinical Trials Unit
GWT-TUD GmbH
AGMT
Geltamo
This is Cancer Research UK trial number CRUKE/21/006.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”