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 trial looking at a new drug called olaparib for leukaemia and mantle cell lymphoma that has stopped responding to treatment (PICLLE)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
All body cells contain DNA. Our genes are made of DNA. Genes control growth, development and how the body works. If DNA becomes damaged (as it has in cancer cells), a protein called PARP-1 helps to repair it. Olaparib is a drug that stops PARP-1 from working. It is called a ‘PARP-1 inhibitor’. If PARP-1 doesn’t work, cancer cells can’t repair themselves and they die.
We know from research that PARP inhibitors can kill cancer cells in the laboratory. Olaparib has already been used in clinical trials to treat patients with solid tumours. In this trial researchers will look at olaparib in people with leukaemia and mantle cell lymphoma. The aims of this 2 stage trial are to
- Find the best dose of olaparib to give
- See how well olaparib works to treat chronic lymphocytic leukaemia (CLL), T-prolymphocytic leukaemia (T-PLL) and mantle cell lymphoma
Who can enter
You can enter this trial if
- You have chronic lymphocytic leukaemia, mantle cell lymphoma or T-Prolymphocytic Leukaemia (T-PLL)
- Your cancer has come back after treatment, or the standard treatment is not working
- You are not able to have any more standard treatment for your cancer
- You have satisfactory blood tests
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- You are willing to use reliable contraception during the trial and for 3 months after you finish the trial medication if there is any chance that you or your partner could become pregnant
- You are at least 18 years old
If you have CLL and take part in phase 2, you must have a gene change in your leukaemia cells, where part of the 11th
You cannot enter this trial if
- You have had treatment for chronic lymphocytic leukaemia, mantle cell lymphoma or T-Prolymphocytic Leukaemia (T-PLL) in the last 4 weeks
- You have CLL that has spread to your brain or spinal cord
- You have had a severe drop in blood cells for more than 8 weeks as a result of cancer treatment
- You have had any other cancer, apart from carcinoma in situ of the cervix, non melanoma skin cancer or early stage slow growing womb cancer (stage 1A and grade 1 womb cancer) that was successfully treated at least 3 years ago
- You are taking steroids at a dose of more than 10mg prednisone per day or similar – please note, you must not stop taking steroids without speaking to your doctor
- You have already had treatment with a PARP inhibitor, including olaparib
- You are allergic or sensitive to olaparib or anything in it
- You have had treatment in another clinical trial in the last 4 weeks
- You have low numbers of white blood cells called neutrophils, or blood clotting cells called platelets – you can ask your doctor about this
- You have had more than 4 bags of red blood cells (called packed red cells) through a drip into a vein in the last month
- You are taking any drugs that affect an enzyme called CYP34A (it is important that you don’t stop taking any medication without talking to your doctor)
- Your liver or kidneys are not working properly
- You have had a heart attack in the last 6 months, or have any other heart condition that is a cause for concern
- You have hepatitis B, hepatitis C or HIV
- You are not able to swallow tablets
- You have fits (seizures) that are uncontrolled by medication
- You have an uncontrolled infection
- You have any other medical or mental health condition that is a cause for concern
- You are pregnant or breastfeeding
This is a phase 1/2 trial. Whether you take part in phase 1 or phase 2 depends on when you join the trial.
The aim of the first phase of the trial is to find the best dose of olaparib. It will recruit between 3 and 18 people. The first patients taking part will have the lowest dose of olaparib. If they don’t have any serious side effects, the next patients will have a higher dose. And so on, until they find the best dose to give. This is called a ‘dose escalation study’.
You will have one of 3 doses of olaparib. The dose you have depends on when you join the trial. Neither you nor your doctor will be able to decide which dose of olaparib you have. Each dose will be given to between 3 and 6 patients. The best dose found in this phase will be used in phase 2 of the trial.
You take olaparib tablets at the same times twice a day for 8 weeks. You swallow them whole with a glass of water. After that, if olaparib is helping you, you will be able to carry on taking it for long as it continues to help.
Phase 2 is to see how well olaparib works in these cancers. It will recruit about 58 people. You take olaparib in the same way as the people in phase 1, but for 16 weeks. After this time you will be able to carry on taking olaparib for as long as it is helping you.
With your permission, the team will continue to gather information from your medical notes after you finish the trial to see how you are getting on.
If you need to stop taking olaparib, your doctor will discuss other possible treatment with you.
Before you start the trial you will see the doctor and have some tests. These tests include
- Physical examination
- Blood test
- Bone marrow biopsy
If you are joining phase 2 you will also have a
- CT scan of your chest, neck, tummy (abdomen) and the area between your hip bones (pelvis)
Lymph node biopsy(if needed)
If you have CLL, you will have a blood test to see if there is a particular gene fault in your cancer cells, called an 11q deletion. You may have already had this test through your regular cancer doctor. You will only be able to take part in the phase 2 part of the trial if your result shows the 11q deletion.
During the trial, everyone will see the doctor and have a blood test
- Every week for the first 8 weeks
- Every 2 weeks for the next 8 weeks
- Once a month until you stop treatment
If you are in phase 2 you will also have another CT scan, a bone marrow biopsy and possibly a lymph node biopsy after the first 16 weeks. This is to see if olaparib is helping your cancer. You may have more CT scans and bone marrow biopsies if your doctor thinks you need them.
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 Guy Pratt
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Birmingham