"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial of dexamethasone and lenalidomide for chronic lymphocytic leukaemia that has got worse or come back after treatment (LenD)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a combination of the drugs lenalidomide and dexamethasone for people with chronic lymphocytic leukaemia (CLL) that has got worse or come back despite having other treatment.
Doctors can treat CLL with chemotherapy. Fludarabine is a drug they often use. If CLL comes back after treatment, your doctor may suggest more chemotherapy, or they may suggest a biological therapy such as alemtuzumab (Campath).
Many people with CLL can have further periods of time when there is no sign of the leukaemia (
Researchers are looking for treatments that cause fewer side effects. In this trial, they are testing another type of biological therapy called lenalidomide.
We know from other trials that lenalidomide may help people with CLL, but it can cause side effects. In this study, people are having a lower dose of lenalidomide alongside a steroid drug called dexamethasone. Doctors already use steroids to treat CLL. And they can also reduce some of the side effects of lenalidomide. The researchers hope that the combination of these 2 drugs will help people with CLL and cause fewer side effects.
The people taking part have CLL that has got worse or come back despite having treatment that included fludarabine or alemtuzumab (or they are unable to have one of these treatments).
The aims of the trial are to
- See how well the combination of dexamethasone and low dose lenalidomide works for people in this situation
- Learn more about the side effects
Who can enter
You may be able to enter this trial if you
- Have chronic lymphocytic leukaemia (CLL) that is getting worse or has come back
- Have had at least 1 other type of treatment for CLL
- Cannot have treatment that includes fludarabine or alemtuzumab
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Are at least 18 years old
- Are willing to use reliable contraception for 4 weeks before starting lenalidomide, during treatment, and for 4 weeks afterwards if there is any chance you or your partner could become pregnant
You cannot enter this trial if you
- Have lymphoma that has changed into conditions called prolymphocytic leukaemia or Richter's syndrome
- Have had radiotherapy, chemotherapy, biological therapy, an
immunotherapydrug with a radioactive molecule attached, or an experimental drug in the last 4 weeks
- Have had major surgery in the last 4 weeks
- Have any other type of cancer that needs treatment, apart from non melanoma skin cancer or prostate cancer
- Have an eye condition called glaucoma, diabetes, high blood pressure or an ulcer in your gut (
peptic ulcer) and the condition cannot be controlled with medication
- Have an infection that cannot be controlled with medication
- Have damage to the nerves in your hands or feet (peripheral neuropathy) unless it is very mild
- Have a medical condition that means you need to take steroids on a long term basis, unless it is a very low dose
- Have certain heart problems – the trial team can advise you about this
- Need to take medication to prevent fits (seizures)
- Are known to be allergic to a drug called
- Are pregnant or breastfeeding
- Have HIV, hepatitis B or hepatitis C
This phase 2 trial will recruit 24 patients. Everybody taking part has dexamethasone and lenalidomide.
You have 4 week cycles of treatment. You take
- Dexamethasone tablets on the first 4 days of each treatment cycle
- Lenalidomide tablets every day
In the 1st cycle of treatment, you have a very low dose of lenalidomide. This goes up to a higher dose from the 2nd cycle onwards. If you have side effects, you stop taking lenalidomide. Once the side effects have got better, you start taking it again at a lower dose.
If the treatment is helping you and you don’t have any bad side effects, you can have up to 12 cycles of treatment, lasting nearly a year.
You see the trial team and have some tests before you start treatment. The tests include
You go to hospital to have a physical examination and blood tests
- 6 times in each of the first 2 treatment cycles
- 4 times in the 3rd cycle
- Once every 4 weeks after that
When you finish treatment, you see the trial team again about 4 weeks later. You have more blood tests, a CT scan and a bone marrow test.
You go back to see the trial team once a month for the next 3 months, and then 6 months after finishing treatment. You have blood tests each time. At the 6 month visit you have a CT scan and you may have a bone marrow test. After that, you see the trial team once a year.
The side effects of lenalidomide include
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- High temperature (fever)
- An abnormal heart beat
- Shortness of breath
- Blood clots
- Changes to the way your kidneys work
- An increased risk of getting some other types of cancer
- Joint or muscle pain
- Taste changes
The side effects of dexamethasone include
- Irritation of the stomach lining causing problems such as indigestion
- An increased appetite
- Changes to your blood sugar levels
- Fluid retention
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 Amit C. Nathwani
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University College London (UCL)