A trial of low intensity transplants for mantle cell lymphoma (MCL MiniAllo)

This trial is looking at having a stem cell transplant using lower doses of chemotherapy, in combination with alemtuzumab (Campath) for mantle cell lymphoma.

Doctors often treat mantle cell lymphoma with chemotherapy. This can work well and all signs of the lymphoma may disappear. This is called remission. But chemotherapy doesn’t usually cure mantle cell lymphoma and when it comes back, it can be difficult to get it into remission again.

Some people have high dose chemotherapy followed by a stem cell transplant for mantle cell lymphoma. But you usually have this after the disease has come back. In this trial, researchers are looking at stem cell transplants as part of the initial treatment.

They are using lower doses of chemotherapy than people usually have before a stem cell transplant. This is called ‘reduced intensity conditioning’ (RIC). You may also hear it called a mini transplant or mini allogeneic transplant (allogeneic means the stem cells come from a donor). Using lower doses of chemotherapy causes fewer side effects than the high dose treatment.

As well as having chemotherapy, you also have a drug called alemtuzumab. This is a monoclonal antibody. It attaches to lymphoma cells and can kill them. It also attaches to certain white blood cells in your body, reducing the risk of your body rejecting the transplant and the chance of a side effect called graft versus host disease (GVHD).

The aims of this trial are

To see if a low intensity stem cell transplant is a safe treatment for people with mantle cell lymphoma
To find out if it is better to have a transplant when people first go into remission, rather than waiting until the lymphoma comes back

Recruitment

Start 01/09/2009

End 30/06/2012

Phase

Phase 2

Who can enter

You can enter this trial if

You have mantle cell lymphoma that has responded to treatment (this can be either a partial response or a complete response)
There is someone who can donate stem cells and they are a HLA matched donor
You are fit enough to have a stem cell transplant
You have satisfactory blood test results
You are willing to use a reliable barrier method of contraception during the trial and for a year afterwards if there is any chance you or your partner could become pregnant
You are at least 18 years old

You cannot enter this trial if you

Have lymphoma that is getting worse despite treatment or has come back after treatment (relapsed)
Have lymphoma that has spread to your brain or spinal cord (central nervous system)
Have had any other cancer in the last 5 years apart from non melanoma skin cancer or cancer in situ of the cervix
Have another serious medical condition that would prevent you having a stem cell transplant or affect you taking part in the trial
Have problems with your heart, lungs, liver or kidneys not working very well
Are known to be HIV, hepatitis B or hepatitis C positive
Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. It will recruit 25 people. Everybody taking part will have the same treatment.

You have a combination of the chemotherapy drugs carmustine, cytarabine, etoposide and melphalan.

You also have alemtuzumab (Campath). These 5 drugs make up the reduced intensity conditioning called BEAM Campath. You start the conditioning 6 days before you have a stem cell transplant.

Doctors will arrange to collect stem cells from your donor. On the day of your transplant, you have the stem cells through a drip. It is a bit like having a blood transfusion. The cells find their own way into your bone marrow and start to grow. Soon they start to make new blood cells for you.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

Physical examination
Blood and urine tests
Bone marrow test
Heart tests (ECG and echocardiogram)
Tests to see how well your lungs are working (lung function tests)
CT scan
Pregnancy test (if you are a women who could possibly become pregnant)

You go into hospital 6 days before the day of your transplant to have the reduced intensity conditioning. You will stay in hospital for quite a few weeks after your transplant.

When you go home, you will have to go back to hospital quite often. This will be at least every week for the first 3 months. After that, you will see the doctors every 3 months for at least 2 years.

You have a CT scan 3 months, 6 months and 1 year after finishing your treatment. And you may need to have a bone marrow test after 3 months.

Side effects

The common side effects of chemotherapy include

Feeling or being sick
Diarrhoea
A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness

There is more information about the side effects of carmustine, cytarabine, etoposide, melphalan and alemtuzumab (Campath) on CancerHelp UK.

After any type of bone marrow or stem cell transplant, there is a risk of graft versus host disease (GVHD). This happens when the new stem cells attack your body tissue. It mainly affects your skin, gut and liver. It can start soon after your transplant (acute) or some time later (chronic).

Alemtuzumab reduces the risk of acute GVHD, but it can still happen. Doctors treat GVHD with drugs that damp down the immune system such as steroids.

Unfortunately, having a transplant may affect you ability to have children (your fertility). Men taking part will be offered the option to store sperm (sperm banking) before starting treatment. Preserving fertility for women is more complicated and it is important that women talk to their doctors about this before starting treatment.