A trial looking at pegylated interferon for polycythaemia and essential thrombocythaemia (Pegasys)

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

Cancer type:

Blood cancers
Polycythaemia
Thrombocythaemia

Status:

Closed

Phase:

Phase 3

This trial is looking at comparing a drug called pegylated interferon with hydroxyurea for the treatment of polycythaemia vera and essential thrombocythaemia. This trial is supported by Cancer Research UK.

Interferon is a drug that boosts the immune system (immunotherapy). Pegylated interferon (pegIFN) is a type of interferon that is designed to stay in the body longer.

Polycythaemia vera is a condition in which the bone marrow makes too many red blood cells. Essential thrombocythaemia is a condition in which the bone marrow makes too many blood cells called platelets. These conditions are part of a group called myeloproliferative disorders.

People with polycythaemia vera and essential thrombocythaemia have an increased risk of developing blood clots. Doctors give them drugs to reduce their risk. Two drugs they can use are hydroxyurea (hydroxycarbamide) and pegIFN. But they aren’t sure which is best at controlling these disorders. In this trial the researchers want to compare these 2 drugs to find out.

The aims of this trial are to compare hydroxyurea with pegIFN to find out

  • Which is best to control polycythaemia vera and essential thrombocythaemia
  • How safe hydroxyurea and pegIFN are
  • More about the side effects

Who can enter

If you have polycythaemia, you may be able to enter this trial if you have at least one of the following

  • A previous blood clot
  • A condition called erythromelalgia that causes skin redness, intense heat and pain in your feet, hands or both
  • Migraines within 10 years of diagnosis that are thought to be caused by your polycythaemia
  • Large spleen
  • Your platelet count is greater than 1,000 (your doctor can tell you this)
  • You are taking medicine for diabetes or high blood pressure

If you have essential thrombocythaemia, you may be able to enter this trial if you have at least one of the following

  • A previous blood clot
  • A previous bleeding episode thought to be caused by your essential thrombocythaemia
  • Your platelet count is greater than 1,500 (your doctor can tell you this)
  • You are taking medicine to control diabetes or high blood pressure

You must also

  • Have been diagnosed in the past 3 years
  • Be willing to use reliable contraception during treatment if there is any chance you or your partner could become pregnant
  • Be at least 18 years old

If you have polycythaemia, your blood cells must also have the JAK 2 gene change (mutation). This is common in polycythaemia.

You cannot enter this trial if you

  • Have myelofibrosis that isn’t caused by polycythaemia vera or essential thrombosis (primary myelofibrosis)
  • Are sensitive, or allergic, to pegIFN or hydroxyurea
  • Have had any other chemotherapy drugs for your condition. If you previously had hydroxyurea for 3 months or less you may still be able to take part
  • Have had another cancer in the past 5 years apart from non melanoma skin cancer and carcinoma in situ of the cervix
  • Are pregnant or breastfeeding
  • Have had a mental disorder, apart from mild depression
  • Are HIV positive
  • Have an infection
  • Have hepatitis B or hepatitis C
  • Have certain problems with your eyes
  • Have certain problems with your liver
  • Have a problem with your thyroid gland that isn’t controlled with medicine
  • Have a blood clot in the blood vessels into your spleen (your doctor can tell you)
  • Have had an organ transplant
  • Have fits (seizures) that aren’t controlled
  • Have, or have had, a problem with your breathing that affects your daily living
  • Have any other medical condition that could affect you taking part in this trial

Trial design

This is an international phase 3 trial. It will recruit 300 people.

It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

  • People in group 1 have pegIFN and aspirin
  • People in group 2 have hydroxyurea and aspirin

Pegasys trial diagram

You have pegIFN as an injection under the skin. You have it once a week. The first week you have a low dose. The dose will go up each week until you reach the maximum dose. When you have reached the maximum dose, the researchers will teach you how to give the injection to yourself, so that you can do it at home.

Hydroxyurea is a capsule. You usually take it once a day. Your doctor will tell you how often you need to take it.

Aspirin is a tablet or capsule. You take it every day with food. If you aren’t able to have aspirin your doctor may give you a different drug.

You continue treatment for a year. If your condition responds you will may continue having treatment for another 5 years.

The trial team will ask you to fill out a questionnaire before starting treatment, a month after starting treatment and then every 3 months during treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

If you agree to take part in this trial the researchers will take extra blood samples to look for substances (biomarkers) to help them with future research into these conditions. You must agree to these to take part in the trial.

Hospital visits

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

  • A physical examination
  • Blood tests
  • Taking toe nail or finger nail clippings
  • An ultrasound (if needed)
  • Bone marrow test
  • Eye examination
  • Heart trace (ECG)

During treatment you see the doctor at weeks 1, 3, 5 and then every 2 months for a physical examination and bloods. After 6 months you see the doctor every 3 months. You have another bone marrow test at year 1 and 2.

After treatment you see the doctor at least once a year for 2 years.

Side effects

The most common side effects of hydroxyurea include

The most common side effects of pegIFN are similar to interferon and include

  • Flu like symptoms such as aches and pain, high temperature (fever), chills, sweating and headache
  • Tiredness
  • Feeling sick
  • Hair loss
  • Depression
  • Loss of appetite
  • Diarrhoea

We have information on hydroxyurea and interferon.

Your doctor will talk to you about the possible side effects before you agree to take part in this trial.

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

Professor Claire Harrison

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Guy's and St Thomas' NHS Foundation Trust
Mario Negri (IRCCS)
Myeloproliferative Disorders Research Consortium (USA)
NIHR Clinical Research Network: Cancer
Roche

Other information

This is Cancer Research UK trial number CRUK/11/048.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

8124

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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