AMoRe 2017
INTERNATIONAL MULTICENTER, OPEN-LABEL, PHASE 2 STUDY TO TREAT MOLECULAR RELAPSE OF PEDIATRIC ACUTE MYELOID LEUKEMIA WITH AZACITIDINE
Rekrutierung beendet
Summary
A phase II study to evaluate the effect and safety of azacitidine treatment in AML subjects at molecular relapse after CR1 with regard to molecular response prior to further treatment.
Main inclusion criteria
- Age 3 months to <21 years with documented diagnosis of AML according to WHO classification with at least one quantitative genetic maker, e.g. one of the following aberrations: t(8;21); RUNX1/RUNX1T1; inv(16); CBFb/MYH11; t(9;11); MLL/AF9; t(10;11); MLL/AF10; NPM1; WT1; etc.
- Molecular remission confirmed at the start of last consolidation course or within 1 month after completion of consolidation treatment
- Detection of a confirmed molecular relapse of an AML
Sponsor
Gesellschaft für Pädiatrische Onkologie und Hämatologie (GPOH) gGmbH