TY  - JOUR
AU  - Platzbecker, Uwe
AU  - Middeke, Jan Moritz
AU  - Sockel, Katja
AU  - Herbst, Regina
AU  - Wolf, Dominik
AU  - Baldus, Claudia D
AU  - Oelschlägel, Uta
AU  - Mütherig, Anke
AU  - Fransecky, Lars
AU  - Noppeney, Richard
AU  - Bug, Gesine
AU  - Götze, Katharina S
AU  - Krämer, Alwin
AU  - Bochtler, Tilmann
AU  - Stelljes, Matthias
AU  - Groth, Christoph
AU  - Schubert, Antje
AU  - Mende, Marika
AU  - Stölzel, Friedrich
AU  - Borkmann, Christine
AU  - Kubasch, Anne Sophie
AU  - von Bonin, Malte
AU  - Serve, Hubert
AU  - Hänel, Mathias
AU  - Dührsen, Ulrich
AU  - Schetelig, Johannes
AU  - Röllig, Christoph
AU  - Kramer, Michael
AU  - Ehninger, Gerhard
AU  - Bornhäuser, Martin
AU  - Thiede, Christian
TI  - Measurable residual disease-guided treatment with azacitidine to prevent haematological relapse in patients with myelodysplastic syndrome and acute myeloid leukaemia (RELAZA2): an open-label, multicentre, phase 2 trial.
JO  - The lancet  / Oncology Oncology
VL  - 19
IS  - 12
SN  - 1470-2045
CY  - London
PB  - The Lancet Publ. Group
M1  - DKFZ-2018-02036
SP  - 1668-1679
PY  - 2018
AB  - Monitoring of measurable residual disease (MRD) in patients with advanced myelodysplastic syndromes (MDS) or acute myeloid leukaemia (AML) who achieve a morphological complete remission can predict haematological relapse. In this prospective study, we aimed to determine whether MRD-guided pre-emptive treatment with azacitidine could prevent relapse in these patients.The relapse prevention with azacitidine (RELAZA2) study is an open-label, multicentre, phase 2 trial done at nine university health centres in Germany. Patients aged 18 years or older with advanced MDS or AML, who had achieved a complete remission after conventional chemotherapy or allogeneic haemopoietic stem-cell transplantation, were prospectively screened for MRD during 24 months from baseline by either quantitative PCR for mutant NPM1, leukaemia-specific fusion genes (DEK-NUP214, RUNX1-RUNX1T1, CBFb-MYH11), or analysis of donor-chimaerism in flow cytometry-sorted CD34-positive cells in patients who received allogeneic haemopoietic stem-cell transplantation. MRD-positive patients in confirmed complete remission received azacitidine 75 mg/m2 per day subcutaneously on days 1-7 of a 29-day cycle for 24 cycles. After six cycles, MRD status was reassessed and patients with major responses (MRD negativity) were eligible for a treatment de-escalation. The primary endpoint was the proportion of patients who were relapse-free and alive 6 months after the start of pre-emptive treatment. Analyses were done per protocol. This trial is registered with ClincialTrials.gov, number NCT01462578, and finished recruitment on Aug 21, 2018.Between Oct 10, 2011, and Aug 20, 2015, we screened 198 patients with advanced MDS (n=26) or AML (n=172), of whom 60 (30
LB  - PUB:(DE-HGF)16
C6  - pmid:30442503
DO  - DOI:10.1016/S1470-2045(18)30580-1
UR  - https://inrepo02.dkfz.de/record/141767
ER  -