A trial looking at low intensity stem cell transplant after chemotherapy for acute myeloid leukaemia and high risk myelodysplastic syndrome - MUNICH

This trial is looking at having a reduced intensity stem cell transplant straight after chemotherapy for acute myeloid leukaemia (AML) and high risk myelodysplastic syndrome (MDS). This trial is for people with AML or high risk MDS that has not responded to treatment or come back after treatment.

Doctors can treat AML and high risk MDS with chemotherapy and a stem cell transplant. They give chemotherapy first to try and get rid of all the cancerous or abnormal cells. After you recover from chemotherapy you have a test to see how well it worked. If your test shows no sign (or nearly no sign) of cancer or abnormal cells, you may have a stem cell transplant. The transplant can be several weeks after chemotherapy. This means having 2 periods of time in hospital, one for chemotherapy and one for the transplant.

The researchers are looking at giving the transplant 3 days after chemotherapy. They are using lower doses of treatment than people usually have before a stem cell transplant. This is called a reduced intensity transplant. This would mean having only one period of time in hospital.

We know from research that reduced intensity transplant can help people whose AML or high risk MDS did not respond to treatment or came back after treatment. We also know that these people could benefit from having the transplant straight after chemotherapy.

The aims of this trial are to find out

How well having a stem cell transplant straight after chemotherapy works for people with AML and high risk MDS that has not responded to treatment or come back after treatment
How long they need to stay in hospital
What the side effects are

Recruitment

Start 01/08/2007

End 31/08/2015

Phase

Phase 2

Who can enter

You can enter this trial if you

Have acute myeloid leukaemia, or high risk myelodysplastic syndrome that has not responded to treatment or has come back after treatment
Have recovered from side effects of treatment you have already had
Can look after yourself and are up and about for more than half the day (performance status 0, 1, 2)
Are willing to use reliable contraception if there is a chance you or your partner could become pregnant
Are 18 to 60 years old

You cannot enter this trial if you

Have had a cancer treatment in the last 14 days – apart from hydroxycarbamide or low dose cytarabine
Had surgery in the last 21 days
Are taking medication as part of another clinical trial
Have a serious problem with your heart
Have had another cancer, unless it was successfully treated and there has been no sign of it (complete remission) in the last 5 years – you may join the trial if you have in situ carcinoma of the cervix and basal or squamous cell cancer of the skin that has been successfully treated
Have another medical condition that could affect you taking part in the trial

Trial design

This is a phase 2 trial. It will recruit between 90 and 95 people in the UK.

Everyone will have chemotherapy before a reduced intensity stem cell transplant.

You have chemotherapy though a drip into the vein over 14 days. Some days you will have more than one drug. You will have

After a break of 3 days you have your stem cell transplant.

You will have some other drugs after your transplant and your doctor will tell you about these.

Hospital visits

You will see the doctor and have some tests before starting treatment. These include

A physical examination
Blood tests
Tests to see how your lungs work (Lung function tests)
Heart scan (Echocardiogram)
Bone marrow test

Even though this trial is looking at reduced intensity transplants, this is still quite intensive treatment. You will be in hospital between 4 and 6 weeks.

When you go home you will have to go back to the hospital quite often. This will be at least every week at the beginning. And then at longer times as your doctor feels is suitable.

You have a bone marrow test 1month and 3 months after your treatment.