Assessment of efficacy of azacitidine to prevent a relapse
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+ or CD117+ MDS or AML or * increase in the AML-specific molecular markers in the quantitative PCR for 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 allogeneic 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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
93
Azacytidine injection: 75 mg/m²/d, subcutaneous; initial minimum 6 cycles; another 6 or 12 cycles according to MRD niveau; maximum 24 cycles
Charité Campus Benjamin Franklin
Berlin, Germany
Universitätsklinikum Bonn
Bonn, Germany
Klinikum Chemnitz (Küchwald)
Chemnitz, Germany
Number of patients with hematological relapse 6 months after start of treatment with azacitidin
Time frame: 6 months after end of treatment
Number of occurrence or exacerbation of clinical relevant acute or chronic GvHD
Time frame: 2 years follow-up after treatment
Number of patients with infectious SAEs (rate of SAE)
Time frame: 2 years follow-up after treatment
Rate of changes of methylation in CD34+ cells
Time frame: 2 years follow-up after treatment
Relapse-free survival and overall survival
Relapse-free survival and overall survival 12, 24 and 30 months after start of treatment
Time frame: 12, 24 and 30 months after start of treatment
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Universitätsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik I
Dresden, Germany
Universitätsklinikum Essen, Klinik für Hämatologie (Westdeutsches Tumorzentrum)
Essen, Germany
Klinikum der J. W. Goethe-Universität, Medizinische Klinik II Hämatologie / Onkologie
Frankfurt am Main, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
Universitätsklinikum Heidelberg, Medizinische Klinik, Abt. Innere Medizin V
Heidelberg, Germany
Klinikum rechts der Isar der TU München, III. Med. Klinik und Poliklinik
München, Germany
LMU München, Klinikum Großhadern, Med. Klinik III
München, Germany
...and 1 more locations