NCT01462578

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Acute Myelocytic Leukemia
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Azacitidine	Azacytidine injection: 75 mg/m²/d, subcutaneous; initial minimum 6 cycles; another 6 or 12 cycles according to MRD niveau; maximum 24 cycles

Timeline

• Start date: 2011-09-01
• Primary completion: 2018-08-01
• Completion: 2021-02-01
• First posted: 2011-10-31
• Last updated: 2021-11-15

Locations

11 sites across 1 country: Germany