A trial looking at polatuzumab vedotin for B cell lymphoma (Pola-R-ICE)
Cancer type:
Status:
Phase:
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:
- when the
first line treatment 
has stopped working - that has come back after treatment
More about this trial
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:
- how well polatuzumab vedotin and RICE works
- what the side effects are
- how this combination affects
quality of life
Who can enter
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.
- You have diffuse large B cell lymphoma (DLBCL) that did not go away after
first line treatment (complete remission) . Or you had a complete remission after having first line treatment but the DCBLC has come back (recurrence ). - The information about the 5 factors that helps your doctor know the likely outlook for DCBL needs to be available. Your doctor will know about this.
- You have had a
PET-CT scan that shows the lymphoma. Your doctor will know this. - You have had first line treatment for your lymphoma. Your doctor can tell you about this.
- Your doctors are planning for you to have
high dose chemotherapy followed by a stem cell transplant if the second line treatment works. - You have satisfactory blood test results.
- You are willing to use contraception during treatment and for a time after if there is any chance you or your partner could become pregnant.
- You are able to look after yourself, are up for at least half the day but might not be able to work (performance status 0, 1 or 2). You might be able to join if your performance status is 3 if it is due to your lymphoma. Your doctor will be able to tell you more about this.
- You are at least 16 years old.
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
- have lymphoma that started in the brain or spinal cord (
primary cancer ) or that has spread from another part of the body to the brain or spinal cord (secondary cancer ) - have Richter’s transformation or you have had chronic lymphocytic leukaemia (CLL)
- have had treatment within 2 weeks of starting trial treatment. This includes experimental drugs used in a clinical trial. Or you are already in a clinical trial that is using an experimental drug or device.
- have had more than 1 course of treatment (first line treatment) for DLBCL. Your doctor will know about this.
- have already had polatuzumab vedotin as part of your treatment
Medical conditions
You cannot join this trial if any of these apply. You:
- have
heart problems , liver problems , lung problems or any other medical problems that could affect you taking part - have HIV and your viral load and or CD4 count is not detectable
- have active hepatitis B or active hepatitis C
- have an active infection
- have had major surgery within 6 weeks of starting trial treatment. This is unless it was to diagnose your lymphoma.
- have any mental health problems that could affect you taking part
Other
You cannot join this trial if any of these apply. You:
- are allergic or sensitive to the treatments used or any of their ingredients
- have a
live vaccine within 4 weeks of starting trial treatment. The COVID 19 vaccines and some seasonal flu vaccines are not live vaccines. - are pregnant or breastfeeding
Trial design
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:
- polatuzumab vedotin and RICE
- RICE
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:
- rituximab
- ifosfamide
- carboplatin
- etoposide
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:
- whether the difference in
genes of DLBCL in the individual affects how well treatment works - more about DLBCL
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:
- before starting treatment
- when you finish treatment then at
- the 3 month and 12 month follow up visits
These are quality of life questionnaires.
Hospital visits
You see the doctor to have tests before taking part. These tests include:
- a
physical examination - blood tests
- PET-CT scan and or a CT scan. You might have a bone marrow test if these scans are not enough. Your doctor will talk to you about it if this the case.
- heart trace (ECG)
- a breathing test to show how well your lungs work
You see the doctor regularly during treatment:
- to see how you are
- for blood tests
- to check for side effects
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.
Side effects
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:
- a drop in blood cells causing an increased risk of infection, bruising, bleeding and tiredness
- nerve changes causing tingling, pain, numbness, pins and needles, weakness and loss of balance
- an allergic reaction that can be mild or severe. Symptoms are skin rash, hives, shortness of breath. Contact your advice line or team if you have any of these symptoms.
- feeling or being sick
- diarrhoea or constipation
- tummy (abdominal) pain
- changes to the level of sugar in your blood
- changes to how your liver works
- tumour lysis syndrome – this can be mild or severe. Your doctor takes blood tests regularly to check.
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:
- loss of appetite, weight loss and taste changes
- changes to your eyesight such as blurred vision
- tiredness (fatigue)
- changes to your heart and lungs
- joint and back pain
- hair loss
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.
Location
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.
Chief Investigator
Professor Andrew Davies
Supported by
Cancer Research UK
F. Hoffmann - La Roche, Limited
Southampton Clinical Trials Unit
GWT-TUD GmbH
AGMT
Geltamo
Other information
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
