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

Description

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

Conditions

Myeloid Malignancy

Study Overview

Study Details

Study overview

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

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

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

Condition
Myeloid Malignancy
Intervention / Treatment

-

Contacts and Locations

Detroit

Henry ford hospital, Detroit, Michigan, United States, 48202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 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
  • 2. \>=30 -180 days post SCT and patients must have ANC\> 1000, PLT \> 50,000
  • 3. Age 18-75 years old
  • 4. Performance score of at least 70% by Karnofsky
  • 5. Adequate kidney and liver function as demonstrated by:
  • 1. Creatinine clearance should be \>60 ml/min
  • 2. Total Bilirubin \<1.5, ALT/AST/Alk Phos \< 2.5 x normal. No evidence of chronic active hepatitis or cirrhosis.
  • 6. 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.
  • 7. Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.
  • 8. Patients must be off any prior chemotherapy, radiotherapy, or other investigational therapy within 2 weeks prior to start treatment
  • 1. Positive for HIV, HBsAg, HCV or other viral hepatitis or cirrhosis from any cause
  • 2. Active or prior CNS leukemia, unless in complete remission for at least 2 months.
  • 3. History of serious chronic mental disorder or drug-abuse accompanied by documented problems of compliance with therapeutic programs.
  • 4. Uncontrolled infection
  • 5. Grade III, IV graft versus host disease (GVHD

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Henry Ford Health System,

Study Record Dates

2026-02-20