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A trial of azacitidine with or without vorinostat for acute myeloid leukaemia or high risk myelodysplastic syndrome (RAvVA)

This trial is looking at azacitidine and vorinostat for people who can’t have intensive treatment for acute myeloid leukaemia (AML) or high risk myelodysplastic syndrome (MDS).

Doctors usually treat AML or high risk MDS with chemotherapy. But this treatment can be intensive. Some people can’t have intensive chemotherapy. You may have less intensive chemotherapy, but there is no standard treatment for people in this situation.

In this trial, researchers are looking at 2 drugs called azacitidine and vorinostat.

Azacitidine is a chemotherapy drug that doctors already use to treat AML in people who cannot have intensive chemotherapy.

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

The aim of the trial is to see if a combination of azacitidine and vorinostat is better than azacitidine alone for people who can’t have intensive chemotherapy for AML or MDS.

Recruitment

Start 25/09/2012
End 30/09/2014

Phase

Phase 2

Who can enter

You may be able to enter this trial if

  • You have acute myeloid leukaemia or myelodysplastic syndrome (MDS) that is considered to be high risk - you may have just been diagnosed, or you may have already had treatment but your disease didn't respond well or has come back
  • You can’t have intensive treatment (your doctor will discuss this with you)
  • You have satisfactory blood test results and 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 the trial and for 3 months afterwards, if there is any chance you or your partner could become pregnant

You cannot enter this trial if you

  • Have a type of AML called acute promyelocytic leukaemia
  • Have chronic myeloid leukaemia (CML) that has become acute (blast phase)
  • Have any other type of cancer
  • Have had a stem cell transplant
  • Have already had azacitidine or similar drugs such as decitabine
  • Have had any other drug that is classed as a histone deacetylase inhibitor if it was used as an anti cancer treatment (your doctor can confirm this)
  • Have had any other cancer treatment, including experimental drugs in the last 30 days
  • Have certain heart problems – the trial doctors can advise you about this
  • Can’t have either of the study drugs for some reason, or are not able to have injections under the skin (subcutaneous injections)
  • Have any serious infection or other medical condition that the trial doctors think could affect you taking part
  • Are pregnant or breastfeeding

Trial design

This phase 2 trial will recruit about 160 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 one group have azacitidine and vorinostat, people in the other group have azacitidine alone.

RAvVA trial diagram

Everybody has 4 week cycles of treatment.

You have azacitidine as an injection just under your skin (subcutaneous injections) once a day for 7 days at the beginning of each treatment cycle.

Vorinostat is in capsules that you swallow. If you are in the group having vorinostat, you take the capsules on 7 days in each cycle of treatment, starting on the 3rd day.

You have 6 cycles of treatment. But if it is helping and you don’t have any bad side effects, the trial doctors will talk to you about having the treatment for longer.

The trial team will ask you to fill out a questionnaire before you start treatment, at the beginning of each treatment cycle and when you finish treatment. The questionnaires ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

You go to hospital to have the azacitidine injections. This means you go to hospital on at least 7 days in each 4 week cycle. Each visit lasts up to 3 hours, but you don’t stay in overnight.

You have regular blood tests and more bone marrow tests at the end of the 1st, 3rd and 6th cycles of treatment.

If you carry on having treatment after 6 cycles, you will continue to have regular blood tests and a bone marrow test every 3 months.

When you finish treatment, you continue to have blood tests once a month for 2 years.

Side effects

The trial team will talk to you about all possible side effects before you agree to join the trial.

The side effects of azacitidine include

  • Feeling or being sick
  • Diarrhoea or constipation
  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • Redness or bruising at the injection site
  • High temperature (fever)
  • Loss of appetite
  • Dizziness
  • Headache
  • Tiredness (fatigue)
  • Breathing difficulties, shortness of breath and chest pain
  • Sore throat
  • Joint or muscle pain
  • Rash and itching

The side effects of vorinostat include

  • Blood clots in the lungs or veins causing shortness of breath or pain and swelling in your legs
  • Feeling or being sick
  • Loss of appetite and weight loss
  • Diarrhoea or constipation
  • Tiredness
  • Dizziness
  • Headache
  • Hair loss
  • Aching muscles
  • High temperature
  • Taste changes and a dry mouth
  • Cough or upper respiratory tract infection
  • A drop in blood cells, causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • Breathing problems
  • Back pain
  • Weakness

Location of trial

For more information

Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you need to print this page and take it to your own doctor to discuss.

Find out how to join a trial or contact our cancer information nurses for other questions about cancer by phone (0808 800 4040), by email, or at

The Information Nurses
Cancer Research UK
Angel Building
407 St John Street
London
EC1V 4AD

Chief Investigator

Professor Charles Craddock

Supported by

Celgene
Experimental Cancer Medicine Centre (ECMC)
Merck
NIHR Clinical Research Network: Cancer
Trials Acceleration Programme (TAP - Leukaemia and Lymphoma Research)
University of Birmingham
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Updated: 5 March 2014