Study on Azacitidine and Donor Cell Levels in MDS or AML Patients After Stem Cell Transplant

Sponsor: Henry Ford Health System

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03850418

Provider View

This clinical trial is exploring whether the drug azacitidine can help maintain healthy donor cell levels in patients with MDS or AML after a stem cell transplant, potentially reducing the risk of cancer returning without increasing complications.

Patient Parameters

Program Overview

The purpose of this study is to see if azacitidine can be safely used after a stem cell transplant to help keep donor cell levels stable in patients with Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML). Researchers believe that this approach might lower the chances of the cancer coming back without causing more side effects like Graft Versus Host Disease (GVHD).

Eligibility Criteria

Inclusion Criteria

  • Patients with MDS, AML, or related conditions who have had a stem cell transplant and show a drop in donor cell levels after 30 days, or have less than 98% donor cells by day 30 or 100 without signs of cancer returning.
  • Between 30 to 180 days after the transplant, with specific blood cell counts (ANC > 1000, Platelets > 50,000).
  • Aged between 18 and 75 years.
  • Have a performance score of at least 70% on the Karnofsky scale, indicating they can care for themselves.
  • Have good kidney and liver function based on specific medical tests.
  • Women who can have children must test negative for pregnancy and agree to use birth control during the study.
  • Able to understand and sign a consent form.
  • Must not have had chemotherapy, radiotherapy, or other experimental treatments in the two weeks before starting the study.

Exclusion Criteria

  • Positive for HIV, hepatitis B, hepatitis C, or any liver disease.
  • Have or had leukemia in the central nervous system unless it has been in remission for at least two months.
  • History of serious mental health issues or drug abuse that affects treatment compliance.
  • Have an uncontrolled infection.
  • Have severe Graft Versus Host Disease (GVHD) of grade III or IV.

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