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)

Status Completed

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 ;

Related Conditions & MeSH terms

• Acute Myelocytic Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

• NCT number: NCT01462578
• Study type: Interventional
• Source: Technische Universität Dresden
• Status: Completed
• Phase: Phase 2
• Start date: September 2011
• Completion date: February 2021