Actively Recruiting
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
Led by Franziska Wachter · Updated on 2026-03-19
37
Participants Needed
2
Research Sites
332 weeks
Total Duration
On this page
Sponsors
F
Franziska Wachter
Lead Sponsor
H
Harvard Clinical and Translational Science Center (Harvard Catalyst)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with AML, MDS, treatment-related myeloid neoplasm, myeloid sarcoma, or acute undifferentiated leukemia
- Age between 1 and 39 years
- Receiving an allogeneic hematopoietic stem cell transplant
- Any donor type, graft source, conditioning, and GVHD prophylaxis allowed
- Registered between 40 days before and 1 day prior to stem cell infusion
- Must be in MRD negative remission post-transplant before treatment start
- ECOG performance status 2 or better (Lansky or Karnofsky score 60% or higher)
- Adequate organ function for transplant per institutional standards
- HIV-positive patients can participate if on effective treatment with undetectable viral load
- Hepatitis B patients must have undetectable viral load on suppressive therapy without drug interactions
- Hepatitis C patients must be cured or have undetectable viral load on treatment without drug interactions
- Patients with malignancy in remission are eligible
- Cardiac function must be NYHA class 2B or better if history of cardiac disease
- Women of child-bearing potential and men must agree to use contraception during and after study
- Willing and able to sign informed consent
You will not qualify if you...
- Unresolved adverse events from prior cancer therapy above grade 2 except bone marrow suppression
- Enrolled in another study that prevents starting maintenance therapy
- Allergic reactions to decitabine or filgrastim or related compounds
- Uncontrolled active illness
- Unable to attend clinic visits for at least 7 months post-treatment start
- Presence of FLT3/ITD mutations unless co-occurring NUP28 mutation
- Active concurrent malignancy not in remission
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
F
Franziska Wachter, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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