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

Stopped early · Phase 2

Conditions studied: Acute Myeloid Leukemia (AML) With Multilineage Dysplasia Following Myelodysplastic Syndrome, in Adults, AML (Adult) With 11q23 (MLL) Abnormalities, AML (Adult) With Del (5q), AML (Adult) With Inv (16) (p13; q22), AML (Adult) With t (16;16) (p13; q22), AML (Adult) With t (8; 21) (q22; q22), Secondary AML (Adult), Untreated AML (Adult)

In brief

This phase 2 study evaluates the sequential combination of decitabine then midostaurin for the treatment of newly-diagnosed acute myeloid leukemia (AML) in older patients.

Key facts

Study ID

NCT01846624

Run by

David Iberri

People needed

13

Starts

2013-06-01

Expected to finish

2016-08-31

Last updated by the study team

2018-09-27

Who can join

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

You may qualify if…

• Newly-diagnosed acute myeloid leukemia (AML) per the World Health Organization [WHO] 2008 classification [except t (15; 17)], including:
• De novo AML
• Secondary AML
• Secondary AML arising from previously-diagnosed myelodysplastic syndromes (MDS) treated with deoxyribonucleic acid (DNA) methyltransferase inhibitor (DNMTi) (ie, decitabine or azacitidine)
• FLT3-ITD mutation confirmed in bone marrow aspirate
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN)
• Serum bilirubin ≤ 2.5 ULN
• Serum creatinine ≤ 1.5 mg/dL and/or creatinine clearance ≥ 50 mL/min
• Ejection fraction ≥ 50% by echocardiogram
• Unwillingness or inability to receive conventional chemotherapy
• Ability to understand and the willingness to sign a written informed consent document
• Ability to adhere to the study visit schedule and other protocol requirements
• Life expectancy > 2 months

You may not qualify if…

• Receiving concomitant treatment with other anti-neoplastic agents (EXCEPTION: hydroxyurea). Prior treatment with DNMTi therapy (ie, decitabine or azacitidine) for MDS is allowed
• Received anti-neoplastic treatment within 4 weeks prior to enrollment (EXCEPTION: hydroxyurea)
• Received any surgical procedure, excluding central venous catheter placement or other minor procedures (eg, skin biopsy) within 14 days of study day 1
• Received any investigational agent within 4 weeks prior to enrollment
• Previous or current history of a myeloproliferative disease
• Known active central nervous system (CNS) malignancy
• Any other known disease (except carcinoma in-situ), concurrent severe and/or uncontrolled medical condition which could compromise participation in the study (eg, uncontrolled diabetes; cardiovascular disease including congestive heart failure; myocardial infarction within 6 months with poorly controlled hypertension; chronic renal disease; active uncontrolled infection)
• Active opportunistic infection or treatment for opportunistic infection within 4 weeks of first day of study drug dosing
• Known confirmed diagnosis of human immunodeficiency virus (HIV) infection or active viral hepatitis
• Known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of midostaurin
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to midostaurin and/or decitabine
• Impaired cardiac function including any of the following:
• Screening electrocardiogram (ECG) with a corrected QT interval (QTc) > 450 msec
• Bradycardia defined as heart rate (HR) < 50 beats per minute (bpm)
• Right bundle branch block + left anterior hemiblock (bifascicular block)
• Patients with myocardial infarction or unstable angina < 3 months prior to starting study drug
• Congestive heart failure (CHF) New York (NY) Heart Association class 3 or 4
• Inability to swallow or absorb drug
• Other medical or psychiatric illness or organ dysfunction or laboratory abnormality which in the opinion of the investigator would compromise the patient's safety or interfere with data interpretation
• Unwillingness or inability to comply with the protocol
• Pregnant
• nursing (lactating)
• 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 midostaurin medication; highly effective contraception methods as follows:
• Total abstinence, when this is in line with the preferred and usual lifestyle of the subject [periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception]
• Female sterilization (surgical bilateral oophorectomy with or without hysterectomy; or tubal ligation at least six weeks before taking study treatment). In case of oophorectomy alone, reproductive status must be confirmed by follow-up hormone level assessment

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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