The AML18 Trial is an intensive chemotherapy trial for patients over the age of 60 with AML and High Risk Myelodysplastic disease. This randomised 1600 patient trial will evaluate the effect of addin...

Mise à jour : Il y a 4 ans
Référence : EUCTR2013-002730-21

The AML18 Trial is an intensive chemotherapy trial for patients over the age of 60 with AML and High Risk Myelodysplastic disease. This randomised 1600 patient trial will evaluate the effect of adding novel treatment combinations to standard chemotherapy

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Extrait

This trial will aim to answer the following questions: 1)Does a fractionated schedule of two doses of Mylotarg improve upon the current standard of 3mg/m2 on day 1 of course 1? 2)Does the addition of Ganetespib starting at course 2 improve outcomes? 3)Does the addition of either a short or long (maintenance) course of AC220 starting at course 2 improve outcomes? 4)Is MRD status following course 1 of clinical value? In particular, can outcomes be improved by intensifying treatment in patients who show evidence of residual disease following course 1 of treatment? 5)To compare a total of two versus three courses of treatment in patients who are in CR or CRi and MRD -ve after induction course 1 6)To assess the value of Reduced Intensity Allogenic Stem Cell Transplantation as consolidation for patients with a matched sibiling or 8/8 matched unrelated donor.


Critère d'inclusion

  • Acute Myeloid Leukaemia High Risk Myelodysplastic Syndrome