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
Franziska Wachter
Summary
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)
Description
This is a single arm, pilot study to determine if sequential cycles of maintenance therapy with decitabine and filgrastim post allogenic hematopoietic cell transplant (HCT) are feasible and effective in preventing relapse after HCT in pediatric and young adult patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and treatment related myeloid malignancies (tAML/MDS) with either idiopathic disease or underlying germline disorders, including a subset that may be at higher risk for toxicity from treatment. Decitabine in combination with filgrastim after stem cell transplant…
Eligibility
- Age range
- 1–39 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Disease Criteria: Participants must have a histologically confirmed diagnosis of one of the following hematologic malignancies for eligibility, as defined by the criteria below: * 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 * Acute Undifferentiated Leukemia (MPAL and acute leukemia of ambiguous lineage/NOS not eligible) * Note: MDS, AML, MDS/AML, or tMDS/AML as defined above may be idiopath…
Interventions
- DrugDecitabine
Nucleoside metabolic inhibitor, via IV infusion.
- DrugFilgrastim
Recombinant granulocyte colony-stimulating factor (G-CSF), via subcutaneous injection.
Locations (2)
- Boston Children's HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts