Official Title: A Phase II Study of Combination Midostaurin and Decitabine MIDDAC in Elderly Patients Newly Diagnosed With Acute Myeloid Leukemia and FLT3 Mutation
Status: TERMINATED
Status Verified Date: 2018-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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 40
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 CRcomplete response with incomplete recovery CRipartial response PRmorphologic leukemia-free state by end of course 2 receive midostaurin PO BID on days 1-28 Patients achieving CRCRiPRmorphologic leukemia-free state by end of course 8 may continue on current regimen Patients failing to achieve a CRCRiPR 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