Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial of a monoclonal antibody called DI-B4 for low grade B cell lymphoma and chronic lymphocytic leukaemia
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a new drug called DI-B4 for low grade B cell lymphoma and chronic lymphocytic leukaemia (CLL). The people taking part have lymphoma or leukaemia that is getting worse or has come back despite having other treatment. The trial is supported by Cancer Research UK.
More about this trial
Doctors often treat low grade lymphoma and CLL with chemotherapy and a drug called rituximab. But the lymphoma or leukaemia may not respond to treatment or it may come back afterwards. Researchers are looking for new treatments to help people in this situation. In this trial, they are looking at a drug called DI-B4.
DI-B4 is type of biological therapy called a monoclonal antibody. It targets a protein called CD19 that is often found on lymphoma and leukaemia cells. Everybody taking part in this trial has lymphoma or leukaemia that has the CD19 protein (CD19 positive).
The aims of the trial are to
- Find the highest safe dose of DI-B4
- Learn more about the side effects and what happens to the drug in your body
Who can enter
You may be able to enter this trial if you
- Have low grade B cell lymphoma or chronic lymphocytic leukaemia and the cells have the CD19 protein – the trial team will ask your permission to get a sample of cells removed when you had a
biopsyto test for this if it hasn’t been tested for already
- Have had at least one other type of treatment but your lymphoma or leukaemia is not responding or has come back
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Have satisfactory blood test results
- Are at least 18 years old
- Are willing to use reliable contraception during the trial and for 6 months afterwards if there is any chance you or your partner could become pregnant
As well as the above, if you have lymphoma, there must be at least one area of lymphoma that doctors can see on a CT scan and measures at least 1½ cm across (if you have a type of lymphoma called Waldenstrom’s macroglobulinaemia, you don't need to have this).
You cannot enter this trial if you
- Have lymphoma or leukaemia that has spread to your brain or spinal cord and is causing symptoms
- Have had any other cancer treatment (apart from radiotherapy for symptoms) in the last 4 weeks
- Haven’t recovered from the side effects of earlier treatment apart from hair loss or certain other side effects if they are very mild – the trial team can advise you about this
- Have not yet recovered from major surgery to your chest or tummy (
- Have lymphoma that has changed (transformed) from low grade to high grade
- Are taking
steroidsunless it is a low dose or the dose has not changed for at least a week
- Have certain heart problems – the trial team can advise you about this
- Have any other medical condition that the trial team think could affect you taking part
- Are taking part (or planning to take part) in another trial of an experimental treatment
- Are known to be HIV, hepatitis B or hepatitis C positive
- Are pregnant or breastfeeding
This phase 1 trial will recruit about 40 people. Everybody taking part has DI-B4. You have it through a drip into a vein once a week for 4 weeks.
The 1st patient will have the lowest dose of DI-B4 in the first week. As long as they don’t have bad side effects, their dose will then be increased each week. The 2nd patient will have a slightly higher dose that will increase each week and so will the 3rd. The following patients have slightly higher doses, but they have the same dose each week. A few patients will have each dose being tested. If they don’t have bad side effects, the next few patients have a higher dose and so on until the researchers find the best dose to give. This is called a dose escalation study. For the first 3 patients, as well as the dose increasing each week, the time it takes to have the drug may get longer each time.
Once the trial team have worked out the highest dose that at least 6 people have had safely, the rest of the people joining the trial will all have that dose.
You have regular blood tests during the trial so that the researchers can measure how much of the drug is in your blood and see how it is working.
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- Urine test
- Heart trace (
You will need to have a bone marrow test if you haven’t had one in the last 8 weeks. If you have had a bone marrow test in the last 8 weeks, you don’t need to have another one to be able to take part in the trial.
The researchers will ask you to have a bone marrow test before starting DI-B4 as this will help them to learn more about how the drug affects your bone marrow. If you have already had one in the last 8 weeks then this test is optional.
If you are one of the first 3 people in the trial having a different dose each week, you go to hospital
- 3 times a week for the first 4 weeks to have DI-B4 and blood tests
- Once a week for the next 4 weeks to have blood tests
If you have the same dose each week (from the 4th patient onwards), you go to hospital
- 4 times in the first week of treatment
- Twice in the 2nd and 3rd week of treatment
- 3 times in the 4th week of treatment
- Once a week for the next 4 weeks
In the first 4 weeks you have DI-B4 and blood tests. In the following 4 weeks you just have blood tests.
You see the trial team again 8 weeks after finishing DI-B4. You have a physical examination, blood tests and a urine test. You may also need to have a CT scan and a PET scan.
If the bone marrow test you had before starting treatment showed there were lymphoma or leukaemia cells in your bone marrow and your doctor thinks the DI-B4 has helped, you also have another bone marrow test at this time.
If the test you had before treatment was negative, you don’t need to have another test after treatment. But the researchers will ask you to have one to help them learn more about how the drug affects your bone marrow. This is an optional test.
You then see the trial team every 3 months for up to 18 months after starting treatment. You have blood tests each time and you may need to have more scans and bone marrow tests.
This is the first time DI-B4 is being tested in people and there may be side effects we don’t know about yet. The side effects of similar drugs include
- A reaction to the drug that can cause shivering, chills and shortness of breath
- Changes to how your blood clots
- A drop in the number of white blood cells causing an increased risk of infection
- Heart pain (angina) or changes to your heart beat
You have other drugs before having DI-B4 to try to reduce the risk of having a reaction, and the trial team will monitor you closely during treatment.
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.
Dr Andrew Davies
Cancer Research UK (Centre for Drug Development)
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
This is Cancer Research UK trial number CRUKD/12/003.