Spots Global Cancer Trial Database for Treatment of Patients With Myelodysplastic Syndrome or Acute Myelocytic Leukemia With an Impending Hematological Relapse With Azacitidine (Vidaza)
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Trial Identification
Brief Title: Treatment of Patients With Myelodysplastic Syndrome or Acute Myelocytic Leukemia With an Impending Hematological Relapse With Azacitidine (Vidaza)
Official Title: Treatment of Patients With MDS or AML With an Impending Hematological Relapse With Azacitidine (Vidaza)
Study ID: NCT01462578
Interventions
Study Description
Brief Summary: Assessment of efficacy of azacitidine to prevent a relapse
Detailed Description: 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
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Charité Campus Benjamin Franklin, Berlin, , Germany
Universitätsklinikum Bonn, Bonn, , Germany
Klinikum Chemnitz (Küchwald), Chemnitz, , Germany
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, , 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
Universitätsklinikum Münster, Innere Medizin A - KMT-Zentrum, Münster, , Germany
Contact Details
Name: Uwe Platzbecker, Prof. Dr.
Affiliation: Universitätsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik I, 01307 Dresden
Role: PRINCIPAL_INVESTIGATOR
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