Status:
RECRUITING
Azacitidine and Chimerism in MDS or AML Patients After Allogeneic Stem Cell Transplant
Lead Sponsor:
Henry Ford Health System
Conditions:
Myeloid Malignancy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 20 2026
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT03850418
Start Date
July 1 2019
End Date
February 20 2026
Last Update
February 10 2025
Active Locations (1)
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1
Henry ford hospital
Detroit, Michigan, United States, 48202