drugset
drugset / Trial / NCT03164057

A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia

NCT03164057 ↗

Phase 2 Active not recruiting 206 enrolled St. Jude Children's Research Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2017-06-15
Primary completion
2025-09-20
Completion
2027-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified — Intravenous
Subject Decitabine Small molecule — Intravenous
Background Asparaginase Erwinia chrysanthemi Protein / enzyme biologic — Intravenous
Background Asparaginase Erwinia chrysanthemi Protein / enzyme biologic — Intramuscular
Background Cytarabine Small molecule — Intravenous
Background Daunorubicin Small molecule — Intravenous
Background Dexrazoxane Small molecule — Intravenous
Background Etoposide Small molecule — Intravenous
Background Fludarabine Small molecule — Intravenous
Background G-CSF Unknown — Intravenous
Background Hydrocortisone Other / unclassified — Intrathecal
Background Idarubicin Small molecule — Intravenous
Background Methotrexate Small molecule — Intrathecal
Background Mitoxantrone Small molecule — Intravenous
Background Sorafenib Small molecule — Oral

Indications

acute myeloid leukemia myelodysplastic syndrome