Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial looking at DTP3 for lymphoma or myeloma
This trial is looking at a new drug called DTP3 for diffuse large B cell lymphoma or myeloma.
It is for people whose treatment has stopped working or their cancer has got worse.
More about this trial
Sometimes the cancer comes back after treatment or treatment stops working. Doctors are looking at new treatments to help these groups of people. In this trial, they are looking at a new drug called DTP3.
DTP3 is a
The main aims of the trial are to:
- find the best dose of DTP3
- learn what the side effects are
- find out what happens to DTP3 in the body
- find out how well DTP3 works
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
For people who have myeloma the following must apply. You:
- have myeloma that is stage 1, stage 2 or stage 3 that needs to be treated
- have myeloma that the doctor can measure in a blood or urine test
- have myeloma that got worse after your last treatment or treatment stopped working
- have already had treatment that included bortezomib, lenalidomide or thalidomide, daratumumab or similar drugs. You might be able to take part if you had only 2 of these treatments. Your doctor will talk to you about this.
- have had at least 2 different
courses of treatmentin the past
For people who have diffuse large B cell lymphoma the following must apply. You:
- have diffuse large B cell lymphoma that needs treatment
- have a type of lymphoma called non germinal large B cell lymphoma. This only applies to people joining the dose expansion group.
- have at least 2 areas of lymphoma that your doctor can see on a scan that measure more than 1.5cm in length. Or you have one area that measures more than 2cm in length.
- have no
standard treatmentavailable to you
- have lymphoma that got worse after your last treatment or treatment stopped working
As well as the above entry conditions for myeloma and lymphoma, the following must also apply. You:
- have satisfactory blood test results
- are up and about more than half the day, you can look after yourself but might not be able to work (performance status 0, 1 or 2)
- are willing to use reliable contraception during the trial and for a period after if there is any chance you or your partner could become pregnant
- are at least 16 years old
Who can’t take part
You cannot join this trial if any of these apply. You:
- have lymphoma of the brain or spinal cord
- have T-cell histiocyte-rich large B-cell lymphoma
- have a rare type of blood cancer called plasma cell leukaemia (plasma cell myeloma)
- have primary
amyloidosis.Your doctor will know this.
- have had treatment for myeloma or diffuse B cell lymphoma within 28 days of the first dose of DTP3. This doesn’t include having
- are suitable to have a
stem cell transplantor CAR T-cell therapy
- have had a stem cell transplant or CAR T-cell therapy within 12 weeks of joining the trial
- have taken part in another trial with an experimental drug within 28 days of joining this trial or you are having treatment with an experimental drug
- have had radiotherapy within 28 days or might need to have radiotherapy while you are taking part in this trial. You can take part if you are having
radiotherapy to a single area to help with symptoms
- have had another cancer in the past. You can join if you had successfully treated
non melanoma skin cancer, carcinoma in situof the cervix or early prostate cancer. You could join if you had another cancer in the last 3 years and there have been no signs of it since.
You cannot join this trial if any of these apply. You:
- have had a heart attack, significant heart surgery in the last 6 months or any other
heart problemthat needs treatment. The trial team check if you have a heart condition before you join the trial.
- have had a stroke or problems with reasoning, planning, judgment, memory and other thought processes (vascular dementia)
- have a condition called POEMS syndrome
- have a risk of bleeding or you have a bleeding problem
- have moderate to severe tingling and numbness or pain in your hands and feet (
- are having treatment that damps down the
immune system. This includes steroids unless it is a low dose or you are having them for a short time to control symptoms.
- have HIV, an active hepatitis B or hepatitis C infection
- have any other medical condition or mental health problem that the trial team think will affect you taking part
You cannot join this trial if you are pregnant or breastfeeding.
This is a phase 1/2 trial. The researchers would like up to 72 people across the UK to take part. This trial has 2 parts:
- finding the best dose of DTP3 (dose escalation)
- learning more about how the drug works (dose expansion)
The team need about 24 people with either myeloma or lymphoma to join the dose escalation part. The first few people taking part have a low dose of DTP3. The next few people have a higher dose if they don’t have any serious side effects. And so on, until doctors find the best dose. This dose is one that helps the most and has the fewest side effects
The researchers need about 24 people with myeloma and 24 with lymphoma to join this part. This part opens when they find the best dose in part 1.
How you have treatment
You have DTP3 as a drip into a vein. It takes about an hour each time. You have treatment three times a week on the hospital day care ward. This is likely to be on a Monday, Wednesday and Friday. The team can tell you more about this. Everyone has treatment for as long as it is working and the side effects aren’t too bad.
Samples for research
The researchers ask you to give some extra blood samples. Where possible, you have these at the same time as your routine blood tests. They also ask to look at samples of
They plan to use the samples to:
- see how well DTP3 is working
- look at
genesin your cancer cells
- look for substances called
biomarkersto help work out why treatment might work for some people and not for others
- measure DTP3 in the body
You see the doctor and have tests before you can take part. These include:
- blood tests
- urine tests
- heart trace (
- bone marrow test
- CT scan , MRI scan or a PET-CT scan
After the first treatment, you may have an overnight stay in the hospital. This is so the team can take some blood samples to see what happens to DTP3 in the body. If you are unable to stay overnight, they take samples from you on the day care ward. These would stop at the end of the first day, to allow you to return home.
You have one extra bone marrow test or biopsy of cancer tissue. You have this during your third week of treatment.
You have regular check ups and blood tests during treatment.
When you stop treatment, you see the team at your routine hospital appointments. This is to check how you are and if you have started another cancer treatment.
The team phone you every 6 weeks to see how you are if you aren’t having hospital appointments.
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.
Only a few people have had DTP3 in the past and in this study. So the team are not sure what the side effects are. You see the doctor regularly to see if there are any side effects. We’ll add information about these when we know more.
How to join a clinical trial
Dr Aris Chaidos
Imperial College London
Institute of Cancer Research (ICR)
Medical Research Council (MRC)