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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-39
SponsorFranziska Wachter

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

Sponsors and collaborators

Franziska Wachter

Lead sponsor

Dana-Farber Cancer Institute

Sponsor institution

Harvard Clinical and Translational Science Center (Harvard Catalyst)

Collaborator