Using azacitidine to improve donor chimerism in patients with myeloid malignancies after stem cell transplant

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

This study is testing if the drug azacitidine can help patients with acute myeloid leukemia or myelodysplastic syndromes maintain healthy donor cells after a stem cell transplant without causing new complications.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Henry Ford Health System (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Detroit, Michigan)
• Trial ID: NCT03850418 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of azacitidine in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) who have undergone allogeneic stem cell transplantation (SCT). The study aims to determine if azacitidine can be safely administered after SCT to reduce the rate of decreasing donor chimerism, which is associated with relapse, without increasing the risk of graft-versus-host disease (GVHD). Eligible patients will be those who show a drop in chimerism levels post-transplant but do not have concurrent hematologic relapse. The trial will monitor the effects of azacitidine on chimerism and overall patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with AML or MDS who are 30-180 days post-SCT and have experienced a drop in donor chimerism without hematologic relapse.

Not a fit: Patients with active hematologic relapse or those who do not meet the specified chimerism criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could help maintain donor chimerism and reduce relapse rates in patients with myeloid malignancies after stem cell transplant.

How similar studies have performed: Previous studies have suggested that azacitidine may be beneficial in similar contexts, indicating potential for success in this approach.

Eligibility 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

Where this trial is running

Detroit, Michigan

• Henry ford hospital — Detroit, Michigan, United States (Recruiting)

Study contacts

• Study coordinator: shatha farhan, MD

Conditions Myeloid Malignancy