A trial looking at DTP3 for lymphoma or myeloma

Cancer type:

Blood cancers

High grade lymphoma

Lymphoma

Myeloma

Non-Hodgkin lymphoma

Status:

Open

Phase:

Phase 1/2

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

There are a number of ways to treat diffuse large B cell lymphoma or myeloma. Myeloma is also called multiple myeloma.

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 targeted cancer drug Open a glossary item . It aims to kill myeloma or lymphoma cells without affecting normal cells. It might have fewer side effects.

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 treatment in 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 treatment available 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

Cancer related
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 bisphosphonates.
are suitable to have a stem cell transplant or 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 situ of 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.

Medical conditions
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 problem that 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 (peripheral neuropathy )
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

Other
You cannot join this trial if you are pregnant or breastfeeding.

Trial design

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)

Dose escalation
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

Dose expansion
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 bone marrow Open a glossary item or samples of cancer tissue (biopsy ) your doctor may ask for.

They plan to use the samples to:

see how well DTP3 is working
look at genes in your cancer cells
look for substances called biomarkers to help work out why treatment might work for some people and not for others
measure DTP3 in the body

Hospital visits

You see the doctor and have tests before you can take part. These include:

blood tests
urine tests
a physical examination
heart trace (ECG )
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.

Follow up
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.

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.

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.