A trial of MK 8628 for acute myeloid leukaemia and diffuse large B cell lymphoma
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at MK 8628 for people with acute myeloid leukaemia (AML) and diffuse large B cell lymphoma (DLBCL) who have had previous treatment. Some people over 60 years old may have treatment as part of the trial even if they haven’t had previous treatment for their leukaemia or lymphoma.
More about this trial
MK 8628 works by blocking a protein that cancer cells need to grow. We know from early research that MK 8628 might help people with blood cancers such as leukaemia and lymphoma.
In this trial researchers want to find:
- the best dose of MK8628 for people with AML or DLBCL
- how safe MK 8628 is for these people
- what the side effects are
- how well it works
Who can enter
The following bullet points list 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.
You may be able to join this trial if you have acute myeloid leukaemia (AML) and are in one of the following situations:
- You have at least 5% blasts in your
bone marrow 
- You are under 60 years old and your leukaemia has come back (
relapsed ) at least twice - You are 60 years old or older, this is your 1st relapse and you were free of leukaemia for less than a year
- You have relapsed after having an
allogeneic stem cell transplant that was more than 3 months ago - You have the
Philadelphia chromosome and have had 2 types of treatment that included drugs such as imatinib, nilotinib and dasatinib or you had only 1 of these and your AML came back or continued to grow because of a change (mutation ) in the leukaemia cells that make them resistant to these type of drugs
Or
You have diffuse large B cell lymphoma (DLBCL) and are in one of the following situations:
- You have at least 1
lymph node that is at least 15cm and 10cm wide, hasn’t been treated with radiotherapy and can be measured on a CT scan - You have had 2 different
standard treatments for DLBCL - You have had treatment with an anti CD 20
monoclonal antibody or you are not able to have monoclonal antibodies
And all of the following apply. You:
- Finished treatment at least 3 weeks ago (6 weeks for
nitrosoureas and mitomycin C ) - Are able to do everything apart from heavy physical work (performance status 0 or 1)
- Have satisfactory blood test results
- Are willing to use reliable contraception during treatment and for at least 3 months afterwards
- Are at least 18 years old
You cannot join this trial if any of these apply.
Cancer related
- You have acute promyelocytic leukaemia (type M3)
- Your lymphoma started in the brain or spinal cord
- Your lymphoma has spread to the brain or spinal cord and is causing symptoms or hasn’t been treated
- You have leukaemia cells in the fluid around the brain and spinal cord
- You have had
high dose chemotherapy followed by an autologous stem cell transplant within 3 months of starting treatment in this trial - You are on any other treatment for your leukaemia or lymphoma
- You have taken an experimental drug as part of another clinical trial in the past month
- You have ongoing moderate to severe side effects from previous treatment apart from hair loss and moderate
peripheral neuropathy that is stable - You have ongoing (chronic) graft versus host disease (GVHD) or are taking medication that affects your
immune system such as steroids to treat GVHD - You have another cancer that is continuing to grow or needs treatment apart from
non melanoma skin cancer or in situ carcinoma of the cervix that has been treated
Medical conditions
- You have a problem with your
digestive system such as Crohn’s disease that affects how you absorb medication - You have HIV, hepatitis B or hepatitis C
- You have a low number of red blood cells caused by an
autoimmune disease - You have a low number of blood cells called
platelets - You have a condition called disseminated intravascular coagulation (DIC) and doctors cannot control the bleeding
- You have a condition that causes the body to have too much or too little of essential substances for example too much calcium (hypercalcemia) that isn’t controlled by medication
- You have had a heart attack in the past year or any other heart problem such as congestive heart failure or angina that isn’t controlled by medication
- You have high blood pressure that isn’t controlled by medication
- You have any other medical or mental condition that the trial team think could affect you taking part in the trial
Other
- You take any medication that affects body substances called CYP enzymes
- You are unable to swallow tablets or capsules
- You have already had a drug that works in the same way as MK8628
- You are pregnant or breastfeeding
Trial design
This is a phase 1 trial. The researchers need 56 people to join.
The researchers are looking at 2 different doses of MK 8628. The first 6 people taking part will have a low dose of MK 8628. If they don’t have any serious side effects, the next few people will have a slightly higher dose.
MK 8628 is a capsule you take twice a day. You have a diary to write down the dose of MK 8628 you took and when.
You continue taking MK8628 as long as it is helping and the side effects aren’t too bad.
Samples
People who have AML have a bone marrow test done before starting treatment.
People who have DLBCL need to have a small piece of a lymph node taken (a ) if a previous sample isn’t available.
You have extra blood samples taken when you start treatment. The researchers will use these samples to see what happens to MK 8628 in the body. They will also use them to find out more about AML and DLBCL.
Hospital visits
You see the doctor to have some tests before you take part in the trial. These tests include:
- a physical examination
- blood tests
- urine test
- heart trace (
ECG) - bone marrow test for people with AML
- lymph node biopsy for people with DLBCL if needed
- PET-CT scan and CT scan for people with DLBCL
During treatment you see the doctor every 3 weeks for a physical examination and blood tests.
People with AML have a bone marrow test every 3 weeks to week 15 and then every 3 months.
People with DLBCL have a PET-CT scan and CT scan every 3 months.
You see the doctor at the end of treatment and a month later for the same tests you had at the start.
People with AML then see the doctor every 6 weeks for a blood test and a bone marrow test if needed.
People with DLBCL then see the doctor every 3 months for a PET-CT scan and a CT scan.
You continue to see the doctor as part of the trial until your cancer starts to get worse or you start another treatment. Then your doctor will tell you how often they want to see you.
Side effects
MK 8628 is a new drug and there might be side effects we don’t know about yet. You will be monitored during the time you are having the drug and you will have a telephone number to contact the hospital if you are concerned about anything. The most common side effects reported are:
- diarrhoea
- upset stomach
- a drop in blood cells causing an increased risk of infection, bruising, bleeding and shortness of breath
- loss of appetite and changes to taste
- feeling or being sick
- feeling weak and having no energy
- changes to the way your liver works
- itchy skin rash
Your doctor will talk to you about the side effects of MK 8628 before you agree to take part in the trial.
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 David Cunningham
Supported by
Merck, Sharp & Dohme
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
