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Midostaurin and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia and FLT3 Mutation | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Midostaurin and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia and FLT3 Mutation

A Phase II Study of Combination Midostaurin and Decitabine (MIDDAC) in Elderly Patients Newly Diagnosed With Acute Myeloid Leukemia and FLT3 Mutation

NCT02634827•Mayo Clinic

View on ClinicalTrials.gov

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 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.

Eligibility

Age

60 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Unfit for chemotherapy based on investigator assessment or patient not willing to receive intensive induction as advised by investigator
•Untreated, histological confirmed acute myeloid leukemia (AML) based on World Health Organization (WHO) 2008 criteria with either/or both:
•* FLT3 ITD mutation
•* FLT3 TKD mutation
•Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3
•Serum amylase and lipase =\< 1.5 x upper limit of normal (ULN)
•Total bilirubin =\< 1.5 x ULN (does not apply to patients with isolated hyperbilirubinemia \[e.g., Gilbert's disease\], in that case direct bilirubin should be =\< 2 x ULN)
•Alkaline phosphatase =\< 3 x ULN
•Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 2.5 x ULN
•Creatinine =\< 2 x ULN
+4 more criteria

Exclusion Criteria

•Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months after treatment completion
•Highly effective contraception methods include:
•* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject; NOTE: periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception)
•* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
•* Male sterilization (at least 6 months prior to screening); NOTE: for female subjects on the study the vasectomized male partner should be the sole partner for that subject
•* Combination of any two of the following (a+b or a+c, or b+c):
•* a) Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \< 1%), for example hormone vaginal ring or transdermal hormone contraception
•* b) Placement of an intrauterine device (IUD) or intrauterine system (IUS)
•* c) Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
•* NOTE:
+77 more criteria

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Key Dates

Start Date

December 30, 2015

Primary Completion Date

March 18, 2017

Completion Date

June 12, 2018

Last Updated

August 7, 2019

Enrollment

ACTUAL participants

Conditions

Acute Myeloid Leukemia With FLT3/ITD MutationAcute Myeloid Leukemia With Gene MutationsFLT3 Tyrosine Kinase Domain Point MutationSecondary Acute Myeloid LeukemiaUntreated Adult Acute Myeloid Leukemia

Interventions

Decitabine

DRUG

Laboratory Biomarker Analysis

OTHER

Midostaurin

DRUG

SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation

NCT06222580

Acute Myeloid Leukemia With FLT3/ITD MutationAcute Myeloid Leukemia With KMT2A Rearrangement+3 more

View study

RECRUITINGPHASE1

Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML

NCT05024552

Acute Myeloid Leukemia With FLT3/ITD Mutation

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Midostaurin and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia and FLT3 Mutation

Inclusion Criteria

Exclusion Criteria

SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation

Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML

Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute Myeloid Leukemia

Natural Killer Cells Before and After Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia

The Gut Microbiome and Sorafenib Maintenance Therapy in FLT3-ITD Positive AML After Allo-HSCT