Results of the AML 12 trial

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Published: 11 Dec 2017
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Dr Ana Garrido - Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

Dr Garrido speaks with ecancer at the ASH 2017 annual meeting about results from 500 patients enrolled in a risk-adapted phase II trial of intensive chemotherapy followed or not by autologous or allogeneic HCT.

She outlines the cytogenetic and MRD classifications for high, intermediate and low-risk trial arms, and their improved survival endpoints based on risk stratification and subsequent treatment.

Dr Garrido hopes that further NGS validation will confirm markers for risk and response.

ecancer's filming has been kindly supported by Amgen through the ECMS Foundation. ecancer is editorially independent and there is no influence over content.

This is an ongoing trial which started in 2012 and in which we treat patients up to the age of 70 years old with primary acute myeloid leukaemia and with a post-remission allocation depending on cytogenetics and molecular findings and also depending on minimal residual disease after the consolidation.

Can you tell us more about the arms in the trial?

The risk allocation depends, as I said, on the cytogenetics and molecular findings and MRD analysis after the consolidation. We allocate patients into the favourable risk group when they have favourable cytogenetics or molecular findings and who were MRD negative after the end of treatment. Those patients receive high doses of cytarabine as consolidation treatment. In the intermediate risk group we allocate those patients with intermediate cytogenetics and without any of the favourable or unfavourable molecular markers. Those patients receive an autologous stem cell transplant or an allogenic stem cell transplant depending on EBMT score and centre choice. Finally, patients in the other risk group, they are allocated those patients with adverse cytogenetics or with intermediate cytogenetics but with adverse molecular findings or those patients with any genetics but who were MRD positive after the end of treatment. Those patients received an allogeneic stem cell transplant.

You mentioned this is an ongoing trial but are there any differences that you can see in the data so far?

Yes, we have just performed the analysis just now and the preliminary results show that overall survival and event free survival of the whole series is around 58%. According to the different genetic groups and taking also into account MRD, there were statistically significant differences between all the groups. What we can conclude by now is that MRD analysis helped us to differentiate our group of patients, the favourable risk group, with a very favourable outcome but MRD and the other genetic allocation did not differ between intermediate and adverse risk groups.

When it comes to the future for this trial, what are the plans for following up this recent data?

From now on what we have to do is to implement the next generation sequencing analysis to try to find any molecular markers that define better the intermediate risk group which is a group with an adverse prognosis in which we can work to try to differentiate those patients with a better prognosis into this group and to keep going on the analysis of MRD at different time-points of analysis to better differentiate at which moment it is important to analyse the MRD status.