Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT02723435
Eligibility Criteria:
INCLUSION CRITERIA
* Elderly patients with FLT3-mutated acute myeloid leukemia (AML)
* Prior enrollment in Stanford study IRB-25737
* In continued complete remission
* ≥ 30 days but ≤ 90 days post allogeneic hematopoietic cell transplant (HCT); treatment on this study protocol must begin before day 90 post-HCT
* Absolute neutrophil count (ANC) ≥ 1000 cells/uL
* Hemoglobin ≥ 8.0 g/dL and not requiring regular transfusions
* Platelets ≥ 50,000 cells/uL and not requiring regular transfusions
* Aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal (ULN)
* Alanine aminotransferase (ALT) ≤ 2.5 X ULN
* Serum bilirubin ≤ 2.5 times ULN
* Ability to give written informed consent, including via legally authorized representative
* Corrected QT (QTc) ≤ 450 msec
* Ejection fraction (EF) ≥ 45% by 2-dimensional transthoracic echocardiography (TTE) or multiple-gated acquisition (MUGA)
* Sexually active males, including vasectomized males, must agree via informed consent to use a condom during vaginal, anal, or oral intercourse, while taking midostaurin and for 5 months after stopping midostaurin
* Females must have or be:
* Negative pregnancy test, within 21 days of the first dose of midostaurin OR
* Not of childbearing potential as follows:
* Has undergone a hysterectomy or bilateral oophorectomy;
* Has not had menses at any time in the preceding 24 consecutive months
EXCLUSION CRITERIA
* Uncontrolled acute graft-vs-host disease (GVHD) grade 3 to 4
* Uncontrolled active infection
* Evidence of active AML (eg, circulating peripheral blasts on complete blood count)
* Known confirmed diagnosis of human immunodeficiency virus (HIV) infection
* Known confirmed diagnosis of active viral hepatitis
* QTc \> 450 msec
* Congenital long QT syndrome
* History of presence of sustained ventricular tachycardia, history of ventricular fibrillation or torsades de pointes
* Bradycardia defined as heart rate (HR) \< 50 beats per minute (bpm)
* Bifascicular block (right bundle branch block plus left anterior hemiblock)
* Congestive heart failure (CHF) New York Heart Association (NYHA) class 3 or 4
* Cardiac ejection fraction (EF) \< 45% within 28 days prior to starting cycle 1
* Other known malignancy (except carcinoma in situ)
* Other concurrent severe and/or uncontrolled medical condition which could compromise participation in the study, eg:
* Uncontrolled diabetes
* Chronic active pancreatitis
* Myocardial infarction within 6 months
* Poorly-controlled hypertension
* Chronic kidney disease
* Received any investigational agent within 30 days prior to day 1
* Antineoplastic chemotherapy or radiotherapy within 28 days prior to cycle 1
* No plans for concurrent chemotherapy while on study (exception: antineoplastic drugs used as part of GVHD prophylaxis or treatment)
* Any surgical procedure, excluding central venous catheter placement, bone marrow biopsy or other minor procedures (eg, skin biopsy) within 14 days of day 1
* Unwillingness or inability to comply with the protocol
* Known malignant disease of the central nervous system
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to midostaurin
* Concomitant use of strong inhibitors of cytochrome P450 family 3 subfamily A member 4 (CYP3A4)
* Pregnant or lactating
* Women of child-bearing potential
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT02723435
Study Brief:
Protocol Section:
NCT02723435