A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia
Status:
Recruiting
Trial end date:
2027-06-01
Target enrollment:
Participant gender:
Summary
The overall aim of this study is to determine if epigenetic priming with a DNA
methyltransferase inhibitor (DMTi) prior to chemotherapy blocks is tolerable and carries
evidence of a clinical efficacy signal as determined by minimal residual disease (MRD),
event-free survival (EFS), and overall survival (OS). Tolerability for each of the agents, as
well as total reduction in DNA methylation and outcome assessments will be done to
simultaneously obtain preliminary biological and clinical data for each DMTi in parallel.
PRIMARY OBJECTIVES:
- Evaluate the tolerability of five days of epigenetic priming with azacitidine and
decitabine as a single agent DMTi prior to standard AML chemotherapy blocks.
- Evaluate the change in genome-wide methylation burden induced by five days of epigenetic
priming and the association of post-priming genome-wide methylation burden with
event-free survival among pediatric AML patients.
SECONDARY OBJECTIVES
- Describe minimal residual disease levels following Induction I chemotherapy in patients
that receive DMTi.
- Estimate the event-free survival and overall survival of patients receiving a DMTi prior
to chemotherapy courses.