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Decitabine Combined With Filgrastim for Children and Young Adults With AML, MDS and Related Myeloid Malignancies
NCT05796570Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Apr 2023
- Primary completion
- Aug 2026
- Countries
- 1
- Modality
- Cytokines & Interferons, Small Molecules
- Drugs
- decitabinefilgrastim
- Conditions
- acute myeloid leukemia (AML)myelodysplastic syndrome (MDS)Myeloid malignancy
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Overview
Phase 2, open-label trial of decitabine and filgrastim in acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and Myeloid malignancy (2 cohorts). Primary endpoint: Feasibility Failure Rate at 168 days. Started Apr 2023; status: active, not recruiting.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Cohort A: Standard Risk
Participants with standard risk for treatment related toxicities.
Cohort B: Increased Risk
Participants with inherited bone marrow failure (iBMF) with increased risk for treatment related toxicities.
03
Who it enrols
Patients aged 1-39 with AML, MDS, or related myeloid malignancies receiving an allogeneic HCT, in MRD negative remission, with adequate organ function and performance status. Excludes patients with FLT3/ITD mutations (unless co-occurring NUP28 mutation) and concurrent active malignancies.
04
Endpoints
Primary
Feasibility Failure Rate
Secondary
Event-Free Survival
Overall Survival
Treatment Tolerability Rate
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