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

37 Participants
are divided into 2 treatment groups

Locations

2
Boston Children's Hospital02215, BostonMassachusetts, United States
Dana-Farber Cancer Institute02215, BostonMassachusetts, United States

Sponsors and collaborators

Franziska Wachter

Lead sponsor

Dana-Farber Cancer Institute

Sponsor institution

Harvard Clinical and Translational Science Center (Harvard Catalyst)

Collaborator