Phase II Trial Examining Epigenetic Priming With Decitabine Followed by Idarubicin and Cytarabine for Patients With Relapsed or Refractory AML
PRIMARY OBJECTIVES:
I. To determine the morphologic complete remission (CR) rates using a decitabine
(DAC)-priming followed by idarubicin (IDA) and cytarabine (ARAC) in patients with relapsed
or refractory acute myeloid leukemia (AML).
SECONDARY OBJECTIVES:
I. To determine CR without minimal residual disease (CRMRD-), CR with incomplete blood count
recovery (CRi), CR with minimal residual disease (CRMRD+), and CR with incomplete blood
count recovery and with minimal residual disease (CRiMRD+) rates.
II. To estimate the frequency and severity of regimen-related toxicities.
III. To identify biomarkers (e.g., deoxyribonucleic acid [DNA] methylation and expression
changes including interferon regulatory factor [IRF]8) associated with clinical responses.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive decitabine intravenously (IV) over 1 hour on days -4 to 0,
cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes
on days 1-3.
ARM II: Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and
idarubicin as in Arm I.
In both arms, treatment repeats every 28 days for up to 3 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for 5 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Morphologic CR rates defined as absolute neutrophil count (ANC) at least 1,000/μL, platelet count at least 100,000/μL, less than 5% BM blasts, no Auer rods, no morphologic dysplasia, and no evidence of extramedullary disease
The trial will follow an optimal two-stage Simon design. This design has an overall type 1 error rate (alpha) of 10%, and a power of 82% for a true CR rate of 30%. The probability of stopping after the first stage is 70%, if the true CR rate is 10%, and 11%, if the true CR rate is 30%.
Assessed for up to 5 years
No
Derek Stirewalt
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
2588.00
NCT01607645
July 2012
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |