Treatment of Patients With MDS or AML With an Impending Hematological Relapse With Azacitidin (Vidaza)
Analysis of the effectiveness of azacitidine 6 months after start of therapy to prevent a
hematological relapse in MDS or AML patients with significant residuals or an increase of
minimal residual disease (MRD) which is defined as
- decrease of CD34 donor chimerism (<80%) after allogeneic related or unrelated HSCT in
CD34+ MDS or AML or
- increase in the AML-specific molecular markers in the quantitative PCR for t(8,21),
inv16, t(6,9), NPM1+ AML >1% (ratio to reference gene) after conventional chemotherapy
or allogeneic HSCT or
- persistence of the (above) MRD level >1% after conventional chemotherapy or alloge-neic
HSCT
- tolerance of azacitidine
- quality of the response of the MRD (major vs. minor) and the relapse-free survival and
overall survival 12, 24 and 30 months after starting treatment with azacitidine
- modulation of CD34+, NK- and T-cells of MDS and AML patients by azacitidine
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients with hematological relapse 6 months after start of treatment with azacitidin
6 months after end of treatment
Yes
Uwe Platzbecker, Prof. Dr. med.
Principal Investigator
Universitätsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik I, 01307 Dresden
Germany: Federal Institute for Drugs and Medical Devices
TUD-RELA02-048
NCT01462578
September 2011
October 2015
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