A trial of MK 8628 for acute myeloid leukaemia and diffuse large B cell lymphoma

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Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Acute leukaemia

Acute myeloid leukaemia (AML)

Blood cancers

High grade lymphoma

Lymphoma

Non-Hodgkin lymphoma

Status:

Closed

Phase:

Phase 1

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

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 biopsy Open a glossary item ) 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: