This phase I trial studies the effects and safety of adding azacitidine (5-AzaC) to the standard of care (Soc) for patients with relapsed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after being treated with donor stem cell transplant. SoC includes giving an infusion of the donor's white blood cells (donor lymphocyte infusion or DLI) to boost the anticancer effects of the transplant. Giving 5-AzaC after DLI may alter the function of T-cells resulting in reduced incidence of graft versus host disease (GVHD) while maintaining the anticancer effects.
PRIMARY OBJECTIVES: -To determine the Maximum Tolerated Dose (MTD) of 5-AzaC (azacitidine) when given after chemotherapy and DLI in patients with AML/MDS who relapse after allogeneic stem cell transplant. SECONDARY OBJECTIVES: * To determine the rate of Grades II-IV and III-IV acute GVHD (aGVHD) in first 100 days after DLI. * To determine the rates of complete remission (CR), partial remission, (PR) and complete remission with incomplete count recovery (CRi), and overall response rate (CR+ CRi + PR). * To determine overall survival 100 days after DLI. * To determine the effects of increasing dose of 5-AzaC on frequency and absolute number of resting regulatory T-cells (rTregs) and activated Tregs (aTregs) at baseline, 7 days, 14 days, 21 days, and \~60 days after first dose of 5-AzaC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Washington University School of Medicine
St Louis, Missouri, United States
MTD and DLT of azacitidine when given after DLI
MTD is defined as the maximum dose level immediately below the dose level at which 2 patients of a cohort (3 to 6 patients) experience dose-limiting toxicity during the first cycle.
Time frame: 40 days (after DLI)
Rate of Grade II-IV and III-IV acute GVHD based on Glucksberg criteria
Time frame: 100 days (after DLI)
Rates of CR, CRi, PR, and overall response (CR+CRi+PR = overall response)
Time frame: 1 year (after DLI)
Overall survival
Time frame: 100 days (after DLI)
Effects of increasing dose of azacitidine on frequency and absolute number of (resting T-cells) rTregs and (T-cells)Tregs
Time frame: 64 days (Baseline, 7 days, 14 days, 21 days, and ~60 days after first dose of azacitidine
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