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First all-Ireland trial at St James’s for ICORG

Medicine Weekly on 23 January 2002

The success of the first trial set up by the Irish Clinical Oncology Research Group (ICORG) involving patients from both the Republic and Northern Ireland should lead to growing interest internationally in Ireland as a location for leading haematological research.

ICORG has reported a very impressive contribution by the Haematology Department of St James’s Hospital to an international Chronic Myeloid Leukaemia (CML) research study. The opening of the research site at the hospital was completed in a record number of only 16 days with the co-operation of the Irish Medicines Board.

Once open, the site had the highest rate of accrual in Europe. Enrolment for the study commenced in October 2000 and, in just one year, a total of 39 Irish patients were enrolled in the trial. This figure is extraordinary in that it represents over 90 per cent of all CML cases in Ireland during the period of the study.

The exceptional patient enrolment was due to the leadership of Prof Shaun McCann of St James’s Hospital – one of Ireland’s leading international investigators – as well as the co-operation of the members of the Irish Haematological Association. The study was conducted at the St James’s site with patients referred from six of the eight regional health boards, including Northern Ireland.

The objective of the study was to determine the efficacy and safety of a drug called Glivec (formally STI 571), which is manufactured by Novartis, in patients intolerant of/or unresponsive to Interferon alpha. Interferon alpha has been shown by large international studies to be associated with an increase in life expectancy in patients with CML, but due to side effects, many patients discontinue treatment.

Results of the Glivec study have shown that, when given continuously as a single oral daily dose, complete haematological and cytogenetic responses in chronic phase CML have been induced, with reduced side effects.

There are currently a number of trials where the use of this treatment is being tested for a variety of different cancers and plans are also in place to establish a national database for CML which will involve the ongoing monitoring of patients.