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

Stopped early · Phase 2

Conditions studied: Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Gene Mutations, FLT3 Tyrosine Kinase Domain Point Mutation, Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID: NCT02634827
Run by: Mayo Clinic
People needed: 1
Starts: 2015-12-30
Expected to finish: 2018-06-12
Last updated by the study team: 2019-08-07

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Provide informed written consent
Willing to return to consenting Mayo Clinic (Mayo Clinic's campus in Rochester), for follow-up during the Active Monitoring Phase of the study
Willing to provide bone marrow aspirate and blood samples for correlative research purposes

You may not qualify if…

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:
In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment
Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) OR
Sexually active males unless they use a condom during intercourse while taking drug and for 5 months after stopping midostaurin medication
NOTE:
They should not father a child in this period
A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Immunocompromised patients (other than that related to the use of corticosteroids) including patients confirmed to be human immunodeficiency virus (HIV) positive or have active viral hepatitis
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements; patients with any other known concurrent severe and/or uncontrolled medical condition (except carcinoma in-situ), which could compromise participation in the study (e.g. uncontrolled infection, uncontrolled diabetes, chronic active pancreatitis)
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Other active malignancy =< 1 year prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix
Previous treatment with specific chemotherapy (cytarabine, idarubicin, daunorubicin) or hypomethylating drug (decitabine or azacitidine) for a hematological disorder; EXCEPTIONS: prior hydroxyurea allowed; secondary AML is allowed
Impaired cardiac function including any of the following:
Inability to monitor the QT interval on electrocardiogram (ECG)
Congenital long QT syndrome or a known family history of long QT syndrome

Where it is running

Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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