Barts Health NHS Trust

4. Mrs M complains the Trust did not act with sufficient urgency in July 2023 when her husband Mr M reported his leukaemia (cancer of the blood and bone marrow) had reached a serious acute stage (blast phase). She says the Trust should have been aware from his previous history that this could happen again. She says the Trust delayed treatment until September 2023.

5. Mrs M says the delay means that when Mr M was admitted to hospital his condition deteriorated and he sadly died in November 2023. She thinks earlier treatment may have prevented his death. As a result of what happened she has become severely depressed and suffers from anxiety and panic attacks. This has led to her giving up college. She has also suffered financial hardship.

6. The outcomes she seeks are an apology, financial remedy and service improvements.

7. Mr M was diagnosed with chronic myeloid leukaemia (CML) in 2015. This is a rare type of cancer that affects the bone marrow and white blood cells. The Trust treated him with various drugs over the years.

8. Mr M achieved remission in June 2019. Remission is when cancer treatment has reduced or eliminated the symptoms and signs of cancer.

9. The Trust gave Mr M an ablative conditioning allograft in July 2019. This is a transplant where the patient receives healthy stem cells (blood-forming cells) from a donor to replace their own stem cells.

10. The transplant did not clear Mr M’s disease and the Trust gave him further high dose tyrosine kinase therapy (TKI). This is a targeted therapy drug which identifies and attacks specific types of cancer cells while causing less damage to normal cells. In CML, TKIs target the abnormal BCR-ABL protein that causes uncontrolled CML cell growth. The therapy blocks the protein’s function, causing the cancer cells to die

11. Mr M achieved continued remission in September 2020. The Trust gradually withdrew the TKI by July 2022 as he found it difficult to tolerate. Unfortunately, by December 2022 his BCR-ABL was again detectable. When the amount of BCR-ABL in a sample increases, it may mean the treatment is not working.

12. The test results in January 2023 had rising levels of BCR-ABL, showing that Mr M had relapsed. The Trust restarted the TKI, using the drug asciminib. His BCR-ABL fluctuated over the next months, but always showed that disease was present. Mr M’s BCR-ABL levels increased a little in June 2023.

13. In August Mr M had a much greater increase in BCR-ABL levels, with a new population of blasts in his bone marrow. He again developed blast crisis phase. This is when the leukaemia transforms into acute leukaemia. In blast crisis many blast cells (immature white blood cells) fill the bone marrow and there are also more blast cells in the blood. This can stop the production of other cells that are important for survival. It can cause infections, anaemia and the blast cells can spread to other parts of the body.

14. Mr M’s condition deteriorated and he was admitted to hospital on 16 September. Mr M continued to decline and he was admitted to intensive care at the beginning of November, and sadly died two days later. We are very sorry for the significant impact Mrs M suffered following her husband’s death.

19. Mrs M told us the Trust did not act with sufficient urgency when her husband told medical staff he thought he had entered blast crisis phase. We can see what an anxious time this was for Mr M and his family. Mrs M has shared copies of messages Mr M sent to the Trust from 26 July onwards telling the Trust about his concerns.

20. Our adviser explained Mr M’s condition sadly relapsed in January 2023. They said if a patient has had a transplant and later relapses, a cure is not possible. The only option is to closely monitor the patient and try to treat them with a drug such as asciminib (TKI). This is the treatment recommended by the British Society for Haematology (BSH) guidelines.

21. The records show the Trust treated Mr M with asciminib and increased the dosage as the BCR-ABL levels rose. The guidelines do not outline what doses to give for increasing BCR-ABL levels. The manufacturer’s guidance for the drug says, ‘any change in the dosage regimen is at the prescriber's discretion, as necessary for the management of the patient’.

22. We asked our adviser about this. They explained Mr M had a change in his cancer cells called T315I mutation. This makes cancer cells resistant to anticancer drugs. They said asciminib is the most appropriate drug for Mr M as patients with the condition are resistant to other drugs. It is recommended by the BSH guidelines.

23. They said that based on their clinical experience the Trust increased the dosage correctly and in a timely way to try and manage the disease.

24. The BSH guidelines say ‘monitoring should be every three months’. The Trust was monitoring Mr M with blood tests every four weeks, and so more frequently than the guidelines.

25. In June 2023 Mr M’s BCR-ABL test showed the level had slightly risen. The guidance does not say a rise means BCR-ABL tests should be done more frequently. This was a slight rise and our adviser said it would have been reasonable for the Trust to have adhered to the guidance (every three months) or its original plan (every four weeks).

26. The Trust decided it would repeat the test in two weeks rather than four weeks. This did not happen and we can see this caused worry for Mr M and his family.

27. As the Trust had agreed to do repeat tests in two weeks instead of four, it should have done this. Our Principles say ‘public bodies should do what they say they are going to do. If they make a commitment to do something, they should keep to it, or explain why they cannot’.

28. We do not know why the earlier tests did not happen. The Trust realised its mistake and apologised. It carried out the test at the four weeks stage, as usual. This is in line with our Principles which say organisations should acknowledge mistakes ‘apologise, explain what went wrong and put things right quickly and effectively’.

29. Our adviser told us there was no impact from this in relation to treatment. The Trust was already giving Mr M the correct treatment and it did not need to change at this time. We do not uphold this complaint as we can see the Trust apologised as it should and remedied the mistake at the time.

30. By the end of July the BCR-ABL levels had increased again. The Trust increased Mr M’s dose of asciminib but sadly it was not possible to control his disease. Mr M entered blast phase again in August.

31. We understand Mr M’s family thinks he entered blast phase and sadly died because the Trust did not act on the concerns he raised in July. We have not seen evidence this was the case. The Trust was already monitoring Mr M more frequently than guidance recommends, and giving the only treatment it could, in line with the guidance.

32. Our adviser said the Trust made decisions correctly based on reliable blood test results. Our adviser explained there was no treatment it could give to control the disease. It did not fail to act on Mr M’s concerns, it was already doing all it could. Sadly, Mr M died despite the best treatment available.

33. We recognise what a difficult and upsetting experience Mrs M had, and how distressing it was for the family to see Mr M’s sad deterioration. We hope we have been able to explain the Trust did not delay in giving treatment, or disregard Mr M’s concerns.

1. We found the Trust gave Mr M the treatment he needed at the right time. We can see it agreed to carry out some tests earlier than usual, in June, and this did not happen. This did not delay Mr M’s clinical care and we can see the Trust apologised as it should.

2. We do not uphold the complaint.

3. We were sorry to hear about the circumstances that led to Mrs M bringing her complaint to us. We understand what happened to her husband has caused her much distress. We hope this report provides some resolution to her concerns.