Pilot Study on Using Decitabine and Filgrastim After Stem Cell Transplant in Children and Young Adults with Blood Cancers

Sponsor: Franziska Wachter

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05796570

Provider View

This study is exploring whether a combination of two drugs, decitabine and filgrastim, can be safely given after a stem cell transplant to help prevent the return of certain blood cancers in children and young adults.

Patient Parameters

Program Overview

The study aims to find out if it's possible to use decitabine and filgrastim after a stem cell transplant to prevent the return of blood cancers like acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) in children and young adults. The drugs involved in this study are decitabine, which helps stop cancer cells from growing, and filgrastim, which helps the body make more white blood cells.

Description

This study is testing whether giving decitabine and filgrastim after a stem cell transplant can help prevent blood cancers from coming back in children and young adults. The study will include about 37 participants who will receive the treatment for up to 6 months, if they can tolerate it, and will be monitored for 24 months after their transplant. Participants will undergo various procedures, including blood tests and bone marrow biopsies, as part of the study. The study is supported by Dana-Farber Cancer Institute and Boston Children's Hospital.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of certain blood cancers like AML or MDS.
  • Must be receiving a stem cell transplant from a donor.
  • Can enroll in the study from 30 to 10 days before the stem cell transplant.
  • Must be in remission after the transplant before starting the study treatment.
  • No age restrictions, but must be between 1 and 39 years old.
  • Must have good organ function and be in good overall health.
  • Must not have any active infections like HIV, hepatitis B, or hepatitis C unless they are well-controlled.
  • Women and men must agree to use birth control during the study.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Cannot have severe side effects from previous cancer treatments.
  • Cannot be part of another study that doesn't allow this treatment.
  • Cannot have allergies to the study drugs.
  • Cannot have uncontrolled illnesses.
  • Must be able to attend clinic visits for at least 7 months after starting treatment.
  • Cannot have certain genetic mutations that require different treatments.
  • Cannot have another active cancer at the same time.

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