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End of study updates

We are now approaching the SPIRIT 2 Last Patient Last Visit (LPLV) and would therefore like to take this opportunity to highlight a number of actions required prior to study closure.

Dasatinib Transition

All patients currently receiving trial IMP Dasatinib need to be transitioned to commercial stock (i.e. non-IMP TKI) prior to Tuesday 07 March 2018.

The existing Blueteq form for Dasatinib has been amended to include a question relating to SPIRIT 2 patients (see below). This amended form is now live and can be used as required by your NHS Trust. 

Please note you can use this form to transition patients prior to March, despite the wording in the form below. 

  Form example

Imatinib

Imatinib patients stop receiving IMP at study visit 15. Please bear in mind however that these patients also need to have used or returned all trial stock (i.e. Imatinib dispensed with a SPIRIT 2 label) before 07 March 2018. This is especially relevant to SPIRIT 2 patients who have recently reached, or are about to reach visit 15.

Please ensure that pharmacy are aware when patients are due to stop IMP as this may help ensure that IMP is not prescribed or dispensed in error.

Safety Reporting

There is a requirement under the SPIRIT 2 protocol that adverse events and serious adverse events continue to be reported for a period of one month (28 days) following the last dose of IMP.

This means that patients should be followed up for a period of one month following transition to commercial drug and any serious adverse events or adverse events reported in the usual manner.

eCRF Updates

When patients transition to commercial drug, a new study drug log page will need to be added to the eCRF to reflect this. The date of change will be the transition date, the dose will be 0 mg and the reason for change will be ‘STUDY DRUG PERMANENTLY DISCONTINUED’. A comment should also be added to reflect that the patient has been transitioned off IMP.

This transition date for each patient is essential data required in the final safety report for SPIRIT 2. As this report is due shortly after the end of trial, we would appreciate it if you could ensure that the eCRF is updated within 14 days of the patient transitioning to commercial supply. Please contact the trial office if there are any problems in achieving this deadline.

Please let the Spirit office know when you have transitioned your dasatinib patients.

Last modified: Wed, 24 Jan 2018 09:56:01 GMT