A trial looking at whether it is possible for people with chronic myeloid leukaemia to stop taking nilotinib

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Blood cancers

Chronic leukaemia

Chronic myeloid leukaemia (CML)

Leukaemia

Status:

Closed

Phase:

Phase 2

This trial is for people with chronic myeloid leukaemia (CML) who have been taking nilotinib for at least 2 years. It is for people who have had treatment with a drug called imatinib (Glivec) then switched to nilotinib.

Nilotinib is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

In this trial researchers want to see if it is possible for people to stop taking nilotinib after at least 3 years of treatment for CML.

The aims of the study are to find out

How many people are still free of leukaemia 1, 2, 3 and 4 years after stopping nilotinib
Who may benefit most from stopping nilotinib
How stopping the drug affects peoples’ quality of life

Who can enter

You may be able to enter this trial if

You have chronic myeloid leukaemia (CML) with a high level of a protein called BCR-ABL – your doctor can advise you about this
You have had treatment with a drug called imatinib followed by at least 2 years of treatment with nilotinib
Your leukaemia has responded to nilotinib – your doctor can confirm this
You have satisfactory blood test results
You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
You are willing to use reliable contraception during treatment and for a month 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 CML that is causing symptoms (accelerated phase) or your leukaemia is developing very quickly (blast phase)
You have had a stem cell or bone marrow transplant using cells from a donor
Your leukaemia had responded to imatinib before you switched from it to nilotinib – your doctor can confirm this
You have had tests in the past that show there is an unusual change (mutation ) to the genes in your leukaemia cells – your doctor can confirm this
Your dose of nilotinib has had to be lowered in the last 6 months due to a drop in your white blood cells or a drop in your platelets
You have already tried to stop taking nilotinib
You have had a heart attack or chest pain in the last year or have any other serious heart problem
You have had inflammation of your pancreas (pancreatitis) in the last year, or have long term inflammation of your pancreas
You have a problem with bleeding that isn’t due to your leukaemia
You have had another cancer in the last 5 years apart from basal cell skin cancer or in situ carcinoma of the cervix
You have had surgery and not yet fully recovered
You have had an experimental drug as part of a clinical trial in the last month
You are having any medication or herbal treatment that affects an enzyme called CYP3A4
You have any other medical condition that could affect you taking part in this trial
You have problems absorbing tablets
You are pregnant or breastfeeding

Trial design

This is an international phase 2 trial. It will recruit 117 people from different countries around the world.

Everyone will continue to take nilotinib for another year. Then your doctor will take a blood sample to see if you can stop taking it. If you do stop taking it, your doctor will assess you regularly to see if there are signs that the number of leukaemia cells is increasing. If this happens, you will start taking nilotinib again.

If you can’t stop taking nilotinib after the first year in the trial, you continue to take it for another year. Then your doctor will take another blood sample to see if you may be able to stop taking nilotinib.

If you aren’t able to stop nilotinib at these times you will continue having it until the end of the trial.

Trial diagram

If you agree to take part in this study, the researchers will ask for extra blood samples. They will use these samples to look for substances in the blood (biomarkers Open a glossary item ) to see if they can find out more about who may be able to stop taking nilotinib. If you don’t want to give these samples for research, you don’t have to. You can still take part in the trial.

The trial team will ask you to fill out a questionnaire before you start treatment and a number of times during treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.