May 1st 2015. The ENESTPath patient recruitment target has been reached with more than 600 patients recruited.
Enrolment is now closed.
The first results of the study will be submitted to ASH- December 2015.
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ENESTPath - A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML
This trial is looking at switching treatment from imatinib to nilotinib to obtain a deeper MR and then stopping treatment.
We know that CML in chronic phase responds well to imatinib and in some people, so well that they can stop taking therapy without losing response. We also know that some patients may have a deeper molecular response when treated with nilotinib rather than imatinib.
The main aims of this trial are to find out if switching from imatinib to nilotinib can help deepen levels of molecular response to MR 4.5, which if maintained over some time may enable responders to try stopping therapy to see if they can maintain TFR.
Lead investigator is Prof. Jane Apperley- Imperial College, Hammersmith Hospital, London UK.
More detail for UK trial centres see following link:
http://www.cancerresearchuk.org/cancer-help/trials/a-trial-switching-sto...
Sponsor:Novartis Pharmaceuticals
For full international list of countries where this trial is open refer to the following link:
http://clinicaltrials.gov/ct2/show/study/NCT01743989?show_locs=Y#locn