RecruitingPhase 2NCT05796570

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


Sponsor

Franziska Wachter

Enrollment

37 participants

Start Date

Apr 19, 2023

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 1 YearMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This pilot study is testing a maintenance therapy regimen — using two drugs (decitabine and filgrastim) — given after a bone marrow transplant to prevent leukemia or related blood cancers from returning in children and young adults. **You may be eligible if...** - You have a confirmed diagnosis of AML (acute myeloid leukemia), MDS (myelodysplastic syndrome), or a related blood cancer - You have recently undergone a bone marrow (hematopoietic stem cell) transplant - Other disease-specific and post-transplant eligibility criteria apply **You may NOT be eligible if...** - Your cancer diagnosis does not match the specified types - You have not yet had a bone marrow transplant - Other health conditions or timing criteria apply Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDecitabine

Nucleoside metabolic inhibitor, via IV infusion.

DRUGFilgrastim

Recombinant granulocyte colony-stimulating factor (G-CSF), via subcutaneous injection.


Locations(2)

Boston Children's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT05796570


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