About this trial
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)
Eligibility criteria
Qualifiers
AML (relapsed, de-novo or secondary) based on WHO classification
MDS (relapsed, de-novo or secondary) based on WHO classification
Treatment myeloid neoplasm (tMDS/AML; relapsed disease included)
Myeloid Sarcoma
Disqualifiers
Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 2) except for bone marrow suppression.
Participants should not be enrolled on another study that prohibits initiation of maintenance therapy.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to decitabine or filgrastim.
Participants with uncontrolled intercurrent illness.
Trial design
Treatments tested in this trial
- Decitabine
- Filgrastim
Treatment groups
Sponsors and collaborators
Franziska Wachter
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
Harvard Clinical and Translational Science Center (Harvard Catalyst)
Collaborator