A trial looking at ruxolitinib as treatment for polycythaemia vera (The RELIEF study)

Cancer type:

Polycythaemia

Status:

Results

Phase:

Phase 3

This trial compared ruxolitinib with hydroxycarbamide (hydroxyurea) to see which was better at treating symptoms of polycythaemia vera (PV).

More about this trial

Polycythaemia vera is a condition in which the bone marrow makes too many red blood cells. It is one of a group of conditions called myeloproliferative disorders. It is closely related to leukaemia.

Doctors usually treat PV with hydroxycarbamide. But some people still have symptoms such as tiredness, itching, aching muscles and sweating. So researchers are looking for other treatments.

Ruxolitinib is a targeted cancer drug. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow. Ruxolitinib may help to relieve the symptoms of polycythaemia vera.

The aims of this trial were to find:

if ruxolitinib reduced the symptoms of polycythaemia vera more than hydroxycarbamide
how safe it was

Summary of results

The trial team found that ruxolitinib controlled the symptoms of polycythaemia vera only slightly better than hydroxycarbamide.

This was a phase 3 trial. 110 people took part. They were put into treatment groups (randomised Open a glossary item ) by a computer. Neither they or their doctor chose or knew which group they were in. This is called a double blinded trial.

54 people had ruxolitinib
56 people had hydroxycarbamide

RELIEF Study Diagram

At 16 weeks of treatment researchers were looking for a decrease of half or more (50% or more) in the following group of symptoms:

tiredness
itching
muscle aches
night sweats
sweats while awake

In the ruxolitinib group they had the results for 53 people. Of these 23 (43.4%) people had a 50% or more decrease in their symptoms.

In the hydroxycarbamide group the team had the results for 54 people. Of these 16 (29.6%) had a 50% or more decrease.

However the team considered this difference not to be statistically significant Open a glossary item .

Researchers also compared the decrease of individual symptoms between the 2 groups. The greatest difference between the individual symptoms of the groups was itching. The team considered this difference to be statistically significant.

After 16 weeks people were told which group they were in. People taking ruxolitinib were able to continue doing so. People taking hydroxycarbamide were able to crossover and have ruxolitinib instead of hydroxycarbamide.

In the ruxolitinib group 34 people decided to continue with the treatment.

In the hydroxycarbamide group 36 people decided to crossover and have ruxolitinib.

Ruxolitinib benefited both these groups by reducing their symptoms.

The most common side effects of ruxolitinib included:

tiredness
headache
dizziness

The most common side effects of hydroxycarbamide included:

diarrhoea
constipation
tiredness
itching

Blood clots occurred in 1 person who had ruxolitinib and 6 people who had hydroxycarbamide.

The team concluded that, compared with hydroxycarbamide, ruxolitinib did reduce the symptoms of polycythaemia vera but the difference wasn’t statistically significant. They also concluded that ruxolitinib is better than hydroxycarbamide at controlling the individual symptom of itching.

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.