A study of CHOP and Campath for peripheral T cell lymphoma (CHOP-CAMPATH)

Please note this trial is no longer recruiting patients.

This pilot study is looking at chemotherapy with different doses of Campath as the first treatment for peripheral T cell lymphoma.

Peripheral T cell lymphoma is a rare form of non Hodgkin’s lymphoma (NHL). It affects T cells that circulate in your blood. Doctors usually treat this type of NHL with chemotherapy. One of the drug combinations they often use is called CHOP.

Alemtuzumab (Campath) is a monoclonal antibody. It has been in clinical trials to treat some other types of cancer, including a type of T cell lymphoma that affects the skin. There have been some good responses and doctors hope that Campath will help people with peripheral T cell lymphoma.

This trial is looking at a combination of CHOP chemotherapy and Campath. The aims of the trial are

To see if this combination of drugs is safe
To find the best dose of Campath
To see if CHOP and Campath works better than CHOP alone as the first treatment for peripheral T cell lymphoma

Recruitment

Start 15/05/2007

End 31/12/2011

Phase

Phase 1

Who can enter

You can enter this trial if you

Have peripheral T cell lymphoma (unless you have very early disease with no symptoms)
Have satisfactory blood test results
Are well enough to take part in the trial
Are willing to use reliable contraception during the trial (and for 1 month after) if there is any chance you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have a type of NHL called anaplastic large cell lymphoma that makes a lot of a protein called ALK
Have lymphoma in the brain or spinal cord
Have had any other cancer apart from carcinoma in situ of the cervix or non melanoma skin cancer that have been successfully treated
Have had chemotherapy in the past
Have another serious medical condition
Have heart problems
Are hepatitis B, hepatitis C, HIV or HTLV1 positive
Are pregnant or breastfeeding

Trial design

This is a phase 1 trial. Everybody taking part will have CHOP chemotherapy and Campath.

You will have the chemotherapy in 3 week cycles of treatment. You have cyclophosphamide, doxorubicin and vincristine, through a drip into a vein, on the first day of each cycle. And you take steroid tablets (prednisolone) on the first 5 days of every cycle. You will have between 6 and 8 cycles, depending on how well you respond to the treatment.

The first few patients recruited onto the trial will have the lowest dose of Campath. This group of people is called cohort 1. They will have this as an injection under the skin on the 1st day of each cycle of treatment. Depending on any side effects they have, the next group of patients may have a slightly higher dose (cohort 2). This will be 2 injections on the 1st and 3rd days.

Some people have an allergic reaction to Campath. This is most likely to happen the first time you have the drug. So the doctors will give you 2 very small test doses on 2 separate days before the first cycle of treatment. Before you have the test doses, you will have other medicines to reduce the risk of having a bad reaction. After the injections, the doctors will monitor you closely for 2 hours to see if you have a reaction. Even if you have a reaction, you should still be able to carry on with the trial.

Hospital visits

You will go to the hospital to see the doctors and have some tests before you take part in the trial. These include

Physical examination
Blood tests
Chest X-ray
Heart trace (ECG)
Echocardiogram
Bone marrow test
Lymph node biopsy
CT scan
Lumbar puncture

You will go to the hospital to have chemotherapy once every 3 weeks. You will also go to the hospital for the Campath injections. The number of visits will vary, depending on the dose you have. If you have a reaction to Campath when you have your first injection, you may need to spend one night in hospital. But you will be able to have the rest of the injections as an outpatient.

You will have a blood test every week during your treatment and a CT scan after the 3rd and 6th cycles. If you go on to have 8 cycles of treatment, you will have another CT scan after this. You will also have CT scans 3 and 12 months after you finish treatment.

If the tests at the beginning of the trial show that there is lymphoma in your bone marrow, you will have 2 more bone marrow tests. One will be half way through the treatment and one at the end.

After your treatment finishes, you will have follow up appointments

Every 3 months for the first year
Every 6 months the next year
Once a year after that

Side effects

The most common side effects of CHOP are

A drop in blood cells causing an increased risk of infection, bleeding or bruising problems, tiredness or shortness of breath
Feeling or being sick
Hair loss
Numbness or tingling in the hands or feet (peripheral neuropathy)
Difficulty sleeping

There is more information about the side effects of cyclophosphamide, doxorubicin, vincristine and prednisolone on CancerHelp UK.

Some of the common side effects of Campath are