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NCT Number: NCT03850418

Azacitidine and Chimerism in MDS or AML Patients After Allogeneic Stem Cell Transplant

Previous studies provide a rationale for administration of AZA after allo SCT for decreasing chimerism. The investigators hypothesize that azacitidine can be well tolerated after SCT and help decrease rate of decreasing donor chimerism and hence decrease relapse without increasing GVHD

Recruiting

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Henry ford hospital

Detroit, Michigan, 48202, United States

Location status: Recruiting

Location contact

shatha farhan

CONTACT

313-916-5002

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with AML/MDS/MPN, CMML post Allogeneic SCT who experience any drop in total or myeloid chimerism any time after day 30, or their day 30 or day100 myeloid donor chimerism is below 98% without concurrent hematologic relapse (that is, patients with <5% bone marrow blasts as obtained at that time point) will be offered treatment with azacitidine
  • >=30 -180 days post SCT and patients must have ANC> 1000, PLT > 50,000
  • Age 18-75 years old
  • Performance score of at least 70% by Karnofsky
  • Adequate kidney and liver function as demonstrated by:
  • Creatinine clearance should be >60 ml/min
  • Total Bilirubin <1.5, ALT/AST/Alk Phos < 2.5 x normal. No evidence of chronic active hepatitis or cirrhosis.
  • Negative Beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective contraceptive measure while on study.
  • Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.
  • Patients must be off any prior chemotherapy, radiotherapy, or other investigational therapy within 2 weeks prior to start treatment

Exclusion criteria

  • Positive for HIV, HBsAg, HCV or other viral hepatitis or cirrhosis from any cause
  • Active or prior CNS leukemia, unless in complete remission for at least 2 months.
  • History of serious chronic mental disorder or drug-abuse accompanied by documented problems of compliance with therapeutic programs.
  • Uncontrolled infection
  • Grade III, IV graft versus host disease (GVHD

Treatment and study plan

Azacitidine

Drug

azacitidine 32mg/m2 x 5 days every 28 days for minimum of 4 cycles if tolerated

Primary outcomes

  1. The rate of increase or stable donor chimerism

    Time frame: one year

    To determine the rate of increase or stable donor chimerism when using low dose azacitidine post allogenic stem cell transplant (SCT) in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) and myeloproliferative neoplasms (MPN) with documented low or decreasing donor chimerism

Study contacts

Contact information is provided by the study sponsor or research team.

NALINI JANAKIRAMAN, MD

CONTACT

shatha farhan, MD

CONTACT

[email protected]

313 916 5002

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Feb 21, 2019
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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