Recruiting
Phase 2

Azacitidine & Chimerism

Sponsor:

Henry Ford Health System

Code:

NCT03850418

Conditions

Myeloid Malignancy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

azacitidine

Study Details

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 rate of decreasing donor chimerism and hence decrease relapse without increasing GVHD

Conditions

Myeloid Malignancy

Study ID

NCT03850418

Start date

Jul 1, 2019

Status verified date

Feb, 2026

Completion date

Feb 20, 2028

Anticipated

Primary completion date

Feb 20, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

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

Study Design

Enrollment

43 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AZA

azacitidine

Interventions

azacitidine

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

Primary outcome measure

  • The rate of increase or stable donor chimerism [ Time Frame: one year ]

Central Contacts and Locations

Central contacts

Locations

Henry ford hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

shatha farhan

313-916-5002

More Information

Sponsor

Henry Ford Health System

Last update posted

Feb 24, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2026-02-24.