Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A study of CHOP and Campath for peripheral T cell lymphoma (CHOP-CAMPATH)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This pilot study is looking at chemotherapy with different doses of Campath as the first treatment for peripheral T cell lymphoma. This trial is supported by Cancer Research UK.
Peripheral T cell lymphoma is a rare form of non Hodgkin 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
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
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.
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
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
- Flu like symptoms
- A drop in blood cells causing an increased risk of infection, tiredness, shortness of breath, and bleeding or bruising problems
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.
Dr Rod Johnson
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Schering Healthcare Ltd
University College London (UCL)
This is Cancer Research UK trial number CRUKE/04/016.