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)
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
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.
Parallel
Decitabine
DrugNucleoside metabolic inhibitor, via IV infusion.
Filgrastim
DrugRecombinant granulocyte colony-stimulating factor (G-CSF), via subcutaneous injection.
Feasibility Failure Rate (FFR)
Feasibility failure relates to decitabine exposure in the setting of post-hematopoietic stem cell transplant (HCT) maintenance and in combination with filgrastim; FFR is defined as the proportion of participants that do not initiate at least 5 of 6 planned cycles and/or receive fewer than 22/30 overall planned decitabine doses during maintenance phase.
24-Month Probability Event-Free Survival (EFS)
EFS based on the Kaplan-Meier method is defined as the time from HCT until evidence of relapse of myelodysplastic syndrome (MDS) or leukemia, or death from any cause. Participants without an event are censored at the date of last follow-up.
24-Month Probability Overall Survival (OS)
OS based on the Kaplan-Meier method is defined as the time from HCT to death or censored at date of last follow-up
Treatment Tolerability Rate (TTR)
Tolerability is based on select adverse events (AE) deemed probably of definitely related to decitabine; TTR is the proportion of participants with grade 4 non-hematologic (NH) AEs except infection and febrile neutropenia, grade 3 NH AEs causing a delay in treatment by \>14 days, and hematologic AEs including ANC\<500 cells/uL or platelet count\<10,000 cells for \>1 week despite supportive care as well as day 28 ANC and platelet target levels or graft failure.
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Franziska Wachter
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
Harvard Clinical and Translational Science Center (Harvard Catalyst)
Collaborator
