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

Myeloid Malignancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03850418
• Other study ID #: 12592
• Status: Recruiting
• Phase: Phase 2
• Start date: July 1, 2019
• Est. completion date: February 20, 2026

Study information

• Verified date: January 2024
• Source: Henry Ford Health System
• Contact: shatha farhan, MD
• Phone: 313 916 5002
• Email: SFARHAN1[@]HFHS.ORG
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: February 20, 2026
• Est. primary completion date: February 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Myeloid Malignancy
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Henry ford hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of increase or stable donor chimerism	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	one year