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Treatment of Patients With Myelodysplastic Syndrome or Acute Myelocytic Leukemia With an Impending Hematological Relapse With Azacitidine (Vidaza) — RELAZA2  

Myelodysplastic Syndrome Clinical Trial

Official title:
Treatment of Patients With MDS or AML With an Impending Hematological Relapse With Azacitidine (Vidaza)

Clinical Trial Summary

Assessment of efficacy of azacitidine to prevent a relapse

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01462578
Study type Interventional
Source Technische Universität Dresden
Contact
Status Completed
Phase Phase 2
Start date September 2011
Completion date February 2021
View Details
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