Overview

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

Status:
Recruiting
Trial end date:
2024-02-20
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Henry Ford Health System
Treatments:
Azacitidine
Criteria
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