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) 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.

Hospital visits

You see the doctor to have some tests before taking part in this trial. These tests include

  • A physical examination
  • Blood tests
  • Heart trace (ECG)
  • Bone marrow test – if needed

For the 1st year you will still be taking nilotinib. During this time you see your doctor every 3 months.

After a year, your doctor will take blood tests to see if you can stop taking nilotinib. If you can, you see the doctor

  • Every 4 weeks for a year
  • Every 6 weeks for the next year
  • Then every 3 months for the following 2 years

During this time, you have blood tests to find out if you need to start taking nilotinib again.

If you start taking nilotinib again, you see the doctor every 4 weeks for 3 months and then every 3 months for at least 4 years.

If you can’t stop taking nilotinib you see the doctor every 3 months.

When you finish treatment, a doctor or nurse from the trial team will contact you every 3 months to see how you are.

Side effects

You probably know how nilotinib affects you and what the side effects may be.

We have more information about nilotinib on our cancer drugs section.

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Jenny Byrne

Supported by

NIHR Clinical Research Network: Cancer
Novartis

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 11149

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

Last reviewed:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think

Share this page