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5-Azacitidine and DLI in relapsed AML or MDS after allo-SCT
NCT00795548Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2008
- Primary completion
- Oct 2010
- Countries
- 1
- Sponsor
- Heinrich Heine University Düsseldorf
- Modality
- Small Molecules
- Drugs
- azacitidine
- Conditions
- myelodysplastic syndrome (MDS)acute myeloid leukemia (AML)
01
Overview
Phase 2, open-label trial of azacitidine in myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), sponsored by Heinrich Heine University Düsseldorf. Primary endpoint: Best hematological response at 6 months. Started Nov 2008; status: completed.
02
Design
- Study design
- Non-randomizedOpen-labelSingle group
03
Who it enrols
Adults with AML or MDS relapsing after allogeneic stem cell transplantation, eligible for DLI, with adequate organ function and no active infections.
04
Endpoints
Primary
Best hematological response
Secondary
Safety and Toxicity of 5-Azacitidine
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