OncoMatch/Clinical Trials/NCT05796570

A Pilot Study to Evaluate the Feasibility of Post-Hematopoietic Stem Cell Transplant Prophylaxis With Decitabine Combined With Filgrastim for Children and Young Adults With AML, MDS and Related Myeloid Malignancies

Is NCT05796570 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Decitabine and Filgrastim for acute myeloid leukemia.

Phase 2RecruitingFranziska WachterNCT05796570Data as of Jun 2026

Treatment: Decitabine · Filgrastim — The purpose of this study is to examine if it is feasible to administer decitabine and filgrastim after allogenic hematopoietic stem cell transplant (HCT) in children and young adults with myelodysplastic syndrome, acute myeloid leukemia and related myeloid disorders, and if the treatment is effective in preventing relapse after HCT. The names of the study drugs involved in this study are: * Decitabine (a nucleoside metabolic inhibitor) * Filgrastim (a recombinant granulocyte colony-stimulating factor (G-CSF)

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Extracted eligibility criteria

Treatments studied

Chemotherapy

Decitabine

Other

Filgrastim

Cancer type

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Biomarker criteria

Excluded: FLT3 itd mutation

Allowed: NUP28 mutation

Performance status

ECOG/LANSKY/KARNOFSKY 0–2

ECOG performance status ≤2 (Lansky, Karnofsky ≥60%)

Demographics

Ages 1–39

Prior therapy

Must have received: allogeneic hematopoietic stem cell transplant

Patients must be receiving an allogeneic hematopoietic stem cell transplant. All donor types and graft sources are permitted. All conditioning regimens are permitted. All GVHD prophylaxis regimens are permitted.

Lab requirements

Blood counts

adequate organ function to be eligible for allogenic HCT as per institutional standard

Kidney function

adequate organ function to be eligible for allogenic HCT as per institutional standard

Liver function

adequate organ function to be eligible for allogenic HCT as per institutional standard

Cardiac function

NYHA class 2B or better for participants with known history or current symptoms of cardiac disease

Participants must have adequate organ function to be eligible for allogenic HCT as per institutional standard. Participants with known history or current symptoms of cardiac disease should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.

Structured fields extracted by AI. May contain errors — verify against the official protocol.