Secondary Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase II Study of Combination Midostaurin and Decitabine (MIDDAC) in Elderly Patients Newly Diagnosed With Acute Myeloid Leukemia and FLT3 Mutation
This phase II trial studies how well midostaurin and decitabine work in treating older patients with newly diagnosed acute myeloid leukemia and FLT3 mutations. Midostaurin and decitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To determine the complete response rate for elderly patients with FLT3 mutated acute
myeloid leukemia (AML) using midostaurin and decitabine.
SECONDARY OBJECTIVES:
I. Determine the 1-year overall survival (OS) and progression free survival (PFS) rates.
II. Determine overall response rates in patients treated with this regimen. III. Determine
the complete response duration in patients treated with this regimen.
IV. Assess the safety and toxicity of this regimen based on National Cancer Institute (NCI)
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
TERTIARY OBJECTIVES:
I. Assess the prognostic and predictive factors (FLT3 internal tandem duplication [ITD]
versus [vs] tyrosine kinase domain [TKD] mutation) for patients treated with this regimen.
II. Explore genetic targets for this disease.
OUTLINE:
Patients receive decitabine intravenously (IV) over 1 hour on days 1-5 and midostaurin orally
(PO) twice daily (BID) on days 8-21 of courses 1 and 2, and on days 1-28 of each subsequent
course. Patients failing to achieve complete response (CR)/complete response with incomplete
recovery (CRi)/partial response (PR)/morphologic leukemia-free state by end of course 2
receive midostaurin PO BID on days 1-28. Patients achieving CR/CRi/PR/morphologic
leukemia-free state by end of course 8 may continue on current regimen. Patients failing to
achieve a CR/CRi/PR/ morphologic leukemia-free state in bone marrow blasts by end of course 8
go to event monitoring. Treatment repeats every 28 days for up to 18 courses in the absence
of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for up to 2
years.
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