A trial looking at a new drug called olaparib for leukaemia and mantle cell lymphoma that has stopped responding to treatment (PICLLE)

Cancer type:

Blood cancers

Chronic leukaemia

Chronic lymphocytic leukaemia (CLL)

Leukaemia

Low grade lymphoma

Lymphoma

Non-Hodgkin lymphoma

Status:

Results

Phase:

Phase 1/2

The trial team wanted to find the best dose of olaparib to treat leukaemia and lymphoma and if it might help people live longer.

It was open to people with:

More about this trial

All body cells contain DNA. Our genes are made of DNA. Genes control growth, development and how the body works. If DNA is damaged, as it has in cancer cells, a protein called PARP-1 helps to repair it.

Olaparib is a drug that stops PARP-1 from working. It is a PARP-1 inhibitor. If PARP-1 doesn’t work, cancer cells can’t repair themselves and they die.

We know from research that PARP inhibitors can kill cancer cells. Olaparib is already a treatment for people with some types of solid tumours Open a glossary item

In this trial researchers looked at olaparib in people with leukaemia and mantle cell lymphoma.

The aims of this trial were to:

find the best dose of olaparib to have
see how well olaparib works as a treatment for leukaemia and mantle cell lymphoma

Summary of results

When the trial started olaparib was available as a capsule. During the time of the trial olaparib changed to a tablet. The drug company thought a tablet might be better than a capsule.

This means that it was harder to draw firm conclusions from the results of the trial.

The team found that further studies need to be done to find the best dose of olaparib for blood cancers. But that the results suggest that it may help people live longer.

This trial closed in 2015. These results were published in 2018.

About this trial
The researchers planned this trial to have 2 parts.

The 1st part was to find the best dose of olaparib capsule to give. The 2nd part was to find out how well olaparib worked.

The team couldn’t do the 2nd part because the people they needed were taking part in other clinical trials.

These are the results of the 1st part of the trial.

This was a phase 1 trial. 15 people took part. Everyone had olaparib.

The first few people had a low dose and if they didn’t have any severe side effects the next few had a higher dose. And so on until the best dose to give was found.

The last 6 people to join the trial had olaparib as a tablet. So, 9 people had olaparib as a capsule and 6 had it as a tablet.

Results
The team found the best dose of olaparib capsule to give that doesn’t cause unacceptable side effects.

The trial stopped before the team could complete the process of finding the best dose for olaparib tablets.

They looked at the average overall time people lived. For all 15 people it was just over 4 months.

The average length of time for the people who had tablets was just over 4 months. The average length of time for people who had capsules was just over 3½ months.

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Researchers looked at certain gene changes (mutation Open a glossary item

) in the leukaemia and lymphoma to find out if these made a difference to how well olaparib worked. They found that olaparib seemed to work better for people whose leukaemia and lymphoma had a change in the ATM gene.

Side effects

The most common side effects reported included:

a drop in blood cells
tiredness
feeling sick

Conclusion

Even though the team couldn’t complete the trial, they concluded that further studies need to be done to find the best dose of olaparib for blood cancers. These early results suggest that olaparib could possibly work well for blood cancers that have a change in the ATM gene.

Where this information comes from

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.