At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 151 enrolled
Drug / intervention
azacitidinedrug
Likely dose
Azacitidine subcutaneous (specific dose regimen not stated in available text)AI-extracted
Key inclusion· 4
- ✓Diagnosis of refractory anemia with specific cytopenias (hemoglobin <110 g/L requiring transfusion, platelets <100×10⁹/L, or ANC <1.5×10⁹/L) OR refractory anemia with excess blasts
- ✓Age ≥18 years
- ✓Life expectancy >7 months
- ✓Unlikely to proceed to bone marrow or stem cell transplantation following remission
Key exclusion· 9
- ✕Prior treatment with azacitidine
- ✕History of Acute Myeloid Leukemia
- ✕Secondary MDS
- ✕Malignant or metastatic disease within previous 12 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Open-Label Study Comparing Three Alternative Dosing Regimens of Subcutaneous Azacitidine Plus Best Supportive Care for the Treatment of Myelodysplastic Syndromes
In Brief
A Phase 2 clinical trial evaluating azacitidine for Myelodysplastic Syndromes. Completed, enrolled 151 participants across 31 sites.
Detailed Summary
The purpose of this study is to determine if azacitidine, combined with Best Supportive Care (BSC), is effective in treating myelodysplastic syndromes (MDS) when given according to a different doses and dosing schedules.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndromes
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2005
First PostedFeb 2005
Primary CompletionAug 2008
TodayJul 2026
First PostedFeb 1, 2005
Enrollment StartJan 1, 2005
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 21.4 years ago
Interventions
azacitidinedrug
Azacitidine is administered subcutaneously Total of 18 cycles on treatment or early discontinuation.