Mitoxantrone, Etoposide, and Cytarabine (MEC) Following Epigenetic Priming With Decitabine in Adults With Relapsed/Refractory Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndromes (MDS): A Phase 1/2 Study
PRIMARY OBJECTIVES:
I. Estimate the maximum tolerated dose (MTD) of decitabine priming followed by sequential
mitoxantrone hydrochloride/etoposide/cytarabine (MEC) chemotherapy in adults with
relapsed/refractory acute myeloid leukemia (AML).
SECONDARY OBJECTIVES:
I. Determine, within the limits of a Phase 1/2 study, disease response and duration of
remission.
II. Identify biomarkers (e.g., deoxyribonucleic acid [DNA] methylation and/or gene
expression changes) associated with treatment responses.
OUTLINE: This is a phase I, dose-escalation study of decitabine followed by a phase II
study.
Patients receive decitabine intravenously (IV) over 60 minutes on days -9 to -5 (dose level
1), days -11 to -5 (dose level 2), or days -14 to -5 (dose level 3).
INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV over 30 minutes on days
1-5, etoposide IV over 1 hour on days 1-5, and cytarabine IV over 1 hour on days 1-5.
Patients achieving complete response (CR) or CR with incomplete platelet count recovery
(CRp) may receive up to 2 courses of induction therapy and up to 2 courses of consolidation
therapy.
After completion of study treatment, patients are followed up every 3 months for up to 5
years.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD of decitabine defined as the highest dose in which the incidence of dose limiting toxicity (DLT) is < 33%, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
Day 45
Yes
Roland Walter
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
2652.00
NCT01729845
December 2012
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |